Patient Perspectives on a Digital Therapeutic for Schizophrenia: A Qualitative Evaluation of an App for Negative Symptoms

Abstract

Background

Negative symptoms of schizophrenia are highly predictive of poor functional outcomes, and current treatment approaches have been minimally efficacious for these symptoms. CT-155/BI 3972080 (CT-155) is being developed as a smartphone-based digital therapeutic (DTx) rooted in evidence-based psychosocial interventions. Patient feedback on the usability, facilitators, and barriers to app use are of critical importance for long-term effectiveness of CT-155.

Study Methods

This qualitative analysis explored user experiences with a beta version of CT-155 (CT-155 beta) following participation in an exploratory clinical study. Semistructured interviews were conducted with 42 participants at the end of a multicenter, 7-week, single-arm, open-label, study of CT-155 beta (NCT05486312). Thematic analysis was used to identify key patterns in participant experiences, focusing on usability, perceived benefits, and challenges.

Study Results

Participant feedback revealed insights regarding: (1) usability of the app, (2) benefits of use, and (3) considerations for implementation. Participants described the app as accessible and easy to navigate, even among those with limited digital experience. The reported benefits included improved coping, increased motivation, increased social interest and skills, new thought patterns, and engagement with structured daily routines. Implementation considerations included technical issues, a desire for more personalization, and the influence of psychiatric symptoms.

Conclusions

This study provides early insights into patient experiences after using CT-155 beta. The findings support the acceptability of the app and offer user-informed direction for future development. These results informed updates to the study app, which has been evaluated in a phase III confirmatory study.

Introduction

Negative symptoms represent a significant and pervasive challenge for individuals living with schizophrenia, profoundly impacting quality of life.^1–6 Despite promising psychosocial treatments (eg, social skills training, cognitive restructuring, behavioral activation, positive affect training) and ongoing pharmacological research,^7–10 limited incorporation of patient perspectives in treatment development poses a critical barrier to access and engagement, preventing sustained and clinically meaningful improvements in negative symptoms.^11,12 Consequently, negative symptoms are a substantial and critical unmet treatment need.¹³

Digital interventions represent a promising and innovative approach to addressing negative symptoms.^14–19 By leveraging technology already integrated into patients’ daily lives (eg, smartphones), these interventions may facilitate structured delivery of therapeutic content in real-world contexts, supporting consistent access to treatment, usually alongside traditional in-person care.^14–19 Indeed, high-frequency, brief-format delivery of therapeutic content may not only prove effective for behavioral traits in schizophrenia but also improve accessibility and augment traditional in-person therapies.^14–19

Patient centricity is a key ingredient to successfully developing an effective intervention, and is especially critical when targeting people with schizophrenia who experience complex and unique challenges. An emphasis on patient-centricity is increasingly recognized across healthcare research,^20–24 as exemplified by the US Food and Drug Administration’s (FDA) Patient-Focused Drug Development (PFDD) program.²⁵ Launched in 2012, this initiative recommends integrating patient and caregiver perspectives into the development and evaluation of medical products to ensure treatments address the symptoms and outcomes most valued by those living with various conditions. At a recent PFDD meeting, “Reimagine Schizophrenia,” several people living with schizophrenia reported that medications do not control their symptoms adequately and described the importance of new treatments that make it easier to maintain relationships, help them enjoy daily activities, and improve motivation.²⁶ A survey from the Schizophrenia and Psychosis Action Alliance (SPAA) conducted at this meeting showed that people with schizophrenia and their loved ones desire treatments that target social and occupational outcomes, while minimizing potential risks and side effects.²⁶ Caregivers and family members express similar sentiments in a qualitative study, describing increased motivation and improved role functioning as key treatment targets of importance.²⁷

Research shows when we prioritize lived experience voices, a clear and cohesive message comes through: People with schizophrenia are not satisfied with current treatment options.²⁶ Patient involvement in treatment development, most often through user experience interviews, advisory boards, and/or focus groups, can help address this dissatisfaction and promote equity by ensuring that therapeutic goals reflect outcomes that matter most to patients across different cultural and socioeconomic backgrounds.^28,29 Aligning therapeutic goals with patient-prioritized outcomes not only supports long-term engagement but also helps meet regulatory guidance, which encourages the integration of patient perspectives to streamline product development and evaluation.^25,30 Furthermore, patient input in the development of a digital therapeutic (DTx) supports shared decision-making and fosters integration into care.³¹ When paired with trustworthy design grounded in robust governance, ethical standards, and inclusive user experience, these tools can offer meaningful and reliable support.³¹ This is particularly important for individuals with schizophrenia, who often face stigma and disempowerment in traditional care settings,^32,33 and may benefit from digital interventions that actively promote inclusion and trust.

The development of novel treatments for negative symptoms is only as promising as people’s willingness to engage with them in real-world settings. As for all therapies, treatment success with psychosocial interventions may be strongly linked with patient engagement.³⁴ Meaningful engagement supports the integration of patient-informed psychosocial interventions into daily life, maximizing therapeutic benefit. In addition, condition-specific challenges such as cognitive impairment, low motivation, limited digital literacy,^35,36 and even negative symptoms themselves may limit usability and, consequently, engagement. Therefore, a key challenge for creating new and engaging digital interventions for negative symptoms of schizophrenia is finding the ideal fit between patient capabilities and the demands of the treatment. In other words, successful treatment development for negative symptoms must bridge the gaps between what patients are being asked to do, what patients like to do, and what patients are actually able to do.

Previous digital intervention research studies for people with schizophrenia have considered various design features to best meet the needs and abilities of this population. A prime example of this is DIALOG+, a psychosocial intervention for people with psychosis.^37,38 DIALOG+ was built on existing clinician–patient relationships, where the app was used during routine visits to facilitate therapeutic goal setting, and improve client–patient communication.^39–42 Other digital treatments for schizophrenia have similarly provided additional supports, including peer-to-peer social networking,⁴³ app-specific guidelines for clinicians to support patient engagement,⁴⁴ and access to tech support personnel.¹⁴ These studies show how digital treatments embedded in structures of support help maintain an optimal fit between treatment demands and the unique needs of people with schizophrenia, by mitigating challenges with digital literacy and accessibility that are typical of this population.

Furthermore, digital health treatments have incorporated design strategies to address characteristic cognitive difficulties and motivation deficits. A recent review of user experiences with digital health interventions among people with psychosis found that real-time documentation features (eg, mood or event tracking) helped mitigate memory limitations by allowing users to document events or feelings as they occurred, removing the burden of recall.⁴⁵ Features such as medication, mood, or goal tracking have also been found to motivate users by providing tangible evidence of their efforts. Other game-like elements such as levels, points, challenges, or progress feedback may boost motivation, and reduce apathy by instilling a sense of achievement.^45,46 These findings demonstrate how various design features can lift unnecessary cognitive load and motivate users to make progress at their own pace. High-quality, accessible, and engaging treatments for people with schizophrenia are long overdue. To address this unmet need, CT-155/BI 3972080, a smartphone-based DTx, has been developed as an adjunct to standard-of-care antipsychotic medication in adults with negative symptoms.^47,48 CT-155 aims to target negative symptoms by providing aspects of multiple evidence-based psychosocial interventions, grounded in principles of face-to-face treatment. It is intended to promote effort toward goal-directed behaviors and increase experiences of pleasure during daily activities. We have previously published feasibility, efficacy, and safety data on a beta version of CT-155 (CT-155 beta), which showed high patient engagement, acceptability, within-group effectiveness for negative symptoms, and safety.⁴⁷ This was a 7-week single-arm, open-label (NCT05486312) exploratory study.⁴⁷ After participants in this study completed their 7 weeks, they were asked to complete exit interviews to discuss their experience with CT-155 beta and provide feedback. Here we report a thematic analysis of qualitative data gathered from these interviews.

In this article, we focus on patient perspectives and experiences with CT-155 beta and identify key themes related to user experience, factors contributing to patient satisfaction and acceptability, and perceived benefits. We also explore challenges encountered during app use, with the goal of informing future design improvements and implementation strategies for DTx in mental health care.

Methods

Data Collection

A qualitative analysis was conducted on patient interviews administered at the end of a multicenter, 7-week, single-arm, open-label, exploratory study.⁴⁷ Participants were recruited by individual clinical sites, which used their own preferred methods. Recruitment strategies varied and included tactics such as bus ads, using existing patient databases, online outreach via social media ads, flyers/posters, and contacting referring physicians. Of note, diagnoses for all the participants were confirmed by licensed clinicians. Briefly, the study evaluated the feasibility and acceptability of CT-155 beta in adults with schizophrenia and at least moderate experiential negative symptoms (ClinicalTrials.gov: NCT05486312). The present research reports a thematic analysis of semistructured, voluntary interviews administered at the end of the study.

To be eligible for inclusion in the exploratory study, participants were required to be ≥18 years of age with a primary diagnosis of schizophrenia for ≥1 year (as per the Diagnostic and Statistical Manual of Mental Disorders, fifth edition [DSM-5]) and to exhibit moderate-to-severe experiential negative symptoms (ENSs), defined as a score of ≤30 on the Motivation and Pleasure Self-Report Scale (MAP-SR).⁴⁹ Diagnostic comorbidity was allowed with exclusions for posttraumatic stress disorder (PTSD), bipolar disorder, major depressive disorder, developmental disorders, substance or alcohol-use disorder, or any prominent disorder that would interfere with compliance to the protocol, secondary or otherwise. Participants also had to be receiving a stable dose of ≤2 different antipsychotic medications for ≥12 weeks prior to screening. Participants were also ineligible if they were receiving clozapine or haloperidol, had received psychotherapy within 12 weeks of screening, or presented with prominent positive symptoms that, in the investigator’s opinion, would interfere with effective engagement in treatment for negative symptoms.⁴⁷ All the participants were recruited from outpatient settings. The study protocol was approved by the Western Copernicus Group IRB (approval number: 20220609), with written informed consent obtained from all the participants.⁴⁷ The present research reports a thematic analysis of semistructured, optional interviews administered at the end of the study.

All the participants from the study who completed the 7-week active period with CT-155 beta were invited to take part in a remote, posttreatment, qualitative interview during the 7-day follow-up period after their last day of CT-155 beta concluded. Of the 50 participants enrolled, 43 completed the study and were invited to interview; 42 agreed to participate in interviews conducted remotely via Zoom.

Interviews were conducted by trained personnel who were familiar with and trained in conducting interviews with clinical populations. The interview discussion guide is available in the online supplementary materials. These interviewers were licensed clinical social workers with over 10 years of experience, including direct work with people with schizophrenia and administering user experience interviews. The interviewers were not employed or affiliated with the clinical sites, nor had they previously interacted with the participants. Interviewers first built rapport by asking about several areas of participants’ lives (eg, living situation, mental health status, goals, and phone usage), followed by questions about their experiences with the CT-155 beta app. Interviews specifically explored the following: What was the patient experience of using the app? What factors contributed to patient satisfaction? And what challenges did patients experience? Participants were also invited to share general impressions of the app, describe how they used it in their daily life, reflect on its perceived value and lasting benefit, and comment on whether they would continue to use it themselves and/or recommend to someone else.

Intervention: CT-155 Beta

CT-155 is considered a software-as-a-medical device to treat negative symptoms in people living with schizophrenia. CT-155 beta was an abbreviated 7-week version of the full CT-155 intervention. CT-155 beta was co-designed and developed alongside lived experience users. Additional details on this development process can be found in Snipes et al.⁵⁰

CT-155 beta comprised a 3-week orientation phase, a 4-week active phase, and a remote 1-week follow-up period.⁴⁷ Individual components of CT-155 were designed to incorporate evidence-based principles of psychosocial therapy for negative symptoms, including cognitive restructuring, positive affect training, behavioral activation, and adaptive goal setting. Adaptive goal setting encompassed behavior activation elements, in which activities were adaptively set and gradually increased in difficulty as participants gained skills. Modules in the adaptive goal setting component included important functional areas (ie, social, work and school, and recreation). The cognitive restructuring and positive affect training components were intended to remove barriers and facilitate goal attainment. Throughout the intervention, participants received normalizing messages and cognitive or behavioral strategies to help manage negative experiences related to cognition, beliefs, emotions, and associated behaviors. Further details on CT-155 beta can be found at Goenjian et al.⁴⁷ A selection of screenshots from the CT-155 beta study app are presented in Figure S1.

Data Analysis

All the interviews were audio-recorded, transcribed verbatim, deidentified, and assigned an anonymized identification (ID) number. Transcripts were imported into NVivo 15 software (QSR International) for data management and coding. The goals for analysis included identifying themes that (1) represent participant experience from their own phenomenological perspective and (2) offer a rich description of their experience. In line with these goals, a thematic analysis was conducted.^51,52

First, a team of coders read transcripts several times to become familiar with the data. Two researchers then independently reviewed a sample of transcripts to begin developing an initial coding framework (codebook), through an iterative open-coding process, identifying recurring patterns and topics that emerged from participant interviews.^53,54 Several transcripts were test-coded independently, after which the team met to clarify ambiguous definitions, overlapping codes, and gaps. Through iterative discussions, the codebook was refined and finalized. Test transcripts were recoded using the final version, which was then applied across the full dataset. The team continued consensus coding to ensure reliability, which exceeded 80% across all coding.

Finally, the research team met to review the frequency of codes that emerged and arrive at a consensus on key themes. Themes with limited support from interview texts (ie, infrequently used codes) were removed to ensure that the final themes reflected perspectives that were more prevalent across participants. A data audit trail⁵⁵ of quotes associated with the final set of key themes was created, reviewed, and exemplar quotes were highlighted (see Table 2). Confidence in the final themes was also guided by the occurrence of saturation, which frequently occurs at around 8-10 observations and reflects the point at which additional interviews yield minimal new thematic content.⁵⁶

Table 2.

Key Themes and Illustrative Quotes From Thematic Analysis

Theme	Subtheme	Exemplar quote
Usability of the app	Ease of use	“No, it was very easy to use. It was one of the easiest apps I’ve ever really dealt with, because I really am not computer-inclined or phone-inclined, but the app showed me how to text more often and do more messaging, stuff like that so I could stay in touch with my support group.” (ID23)
	Flexibility	“The content was very well identifiable or easy to understand. You had choices. What type of activity would you like to do? And then would you like to do it for 20 minutes? What time do you want to do this 20 minutes, the schedule, so if you like writing, if you like— hobbies, is the word [they are?] asking for. And so we’ll write. We’ll listen to music.” (ID25)
	Accessible and enjoyable content	“I overall liked the app. It helped build my confidence in people, just being able to go out and do things. And it wasn’t like they were telling me to do it. They asked me to try. So that’s what I did.” (ID11)
	Felt engaged and satisfied with experiences on app	“I really got a lot out of it, more than I had expected I would, and I’m very well pleased with the experience.” (ID20)
Benefits of the app	Coping skills	“Well, so far, everything’s in the—I have higher expectations of myself. So sometimes I feel like I’m stumbling, but I can actually pick myself back up and start all over again. And by participating in your extra-curriculum activity, I’ve actually learned how to get up before 10 o’clock every morning. I look forward to participating in your program. I actually learned a lot of coping skills.” (ID38)
	Increased social interest and skills	“Maybe a little bit, as far as trying to break the ice to speak to somebody that kind of opened me up a little bit because I just had this cloud over me and did not really want to sometimes deal with certain things. And then it kind of helped, it was kind of helpful. When I spoke to somebody, it kind of made me feel a little bit better. Get a smile on somebody’s face and stuff like that. So those are the little positive things, the gestures that it tell me to do that I really got out of the habit of doing.” (ID15)
	New ways of thinking	“I found it helpful, informative, especially the part about curiosity and not dwelling on negative thoughts of rejection … to go out and try new things that would be pleasurable … and replacing thoughts.” (ID2)
	Sense of accomplishment	“It made me feel good that I accomplished something for the day.” (ID5)
Considerations for implementation	Technical issues and literacy	“Only thing, I did not—well, this is on me. The only thing I did not like is—because I really enjoyed the app. But a lot of times when I tried to get back to it later, it was a no-go. So I’d just have to do it the next morning. And then sometimes we would be on another exercise. But somebody was telling me, ‘Well, you should be able to go back to where you left off.’ But I did not know how to do all that.” (ID3)
	Greater personalization	“Sometimes what the app ask you to do, you do what the app ask you because you have to do what’s in the app. But it’s not always right. What the app says is not always right for you personally.” (ID42)
	Content suggestions	“Maybe when they are giving advice … like I’m seeing you right now, a real person giving me advice about the breathing and things like that, that would be much better visually and more easy to connect.” (ID10)
	Symptoms impacting app use	“I did not do that part the way it was supposed to do because I do not have no people that are going to answer my question, like family member. I talk my personal privacy with them, and then that’s it.” (ID42)

Results

Participant Characteristics

Of the 50 participants who enrolled in the exploratory clinical study, 43 completed the study and were invited to interview.⁴⁷ Of those invited, 42 participants completed the semistructured exit interviews and were included in the present analysis. One participant did not attend at the appointed time and did not reschedule and therefore did not partake in the interview. The interviews lasted 45 minutes on average, with a range from 17-63 minutes.

The median age of those who completed the interview was 55 (range: 23-64), the majority were male (n = 34, 81%), most identified as Black or African American (n = 25, 60%), a majority (n = 26, 62%) did not have college-level education, and nearly all (n = 39, 93%) self-reported an annual income of <$25 000. See Table 1 for more participant demographic information. The mean (standard deviation) MAP-SR score at screening was 14.6 (9.2) and the mean Clinical Assessment Interview for Negative Symptoms – Motivation and Pleasure subscale (CAINS-MAP) total score at baseline was 20.3 (8.7). There were no notable differences in patient demographics or clinical characteristics between participants who completed the exit interviews and the overall population that enrolled in the study (Table S1).

Table 1.

Sociodemographic and Clinical Characteristics

Baseline characteristic	Completed interview (n = 42)
Male, n (%)	34 (81)
Age, median (range), years	55.0 (23-64)
Race, n (%)
Black or African American	25 (60)
White	11 (26)
Asian	3 (7)
American Indian or Alaska Native	1 (2)
Other	2 (5)
Ethnicity, n (%)
Hispanic or Latino	9 (21)
Not Hispanic or Latino	33 (79)
Education, n (%)
Less than high school	6 (14)
High school	20 (48)
Some college	11 (26)
College degree	5 (12)
Annual income, n (%)
<$25 000	39 (93)
$25 000-$49 999	3 (7)
Digital literacy
MDPQ, mean (SD)	27.2 (8.2)
Screening assessment
MAP-SR, mean (SD)	14.6 (9.2)
Baseline clinical assessments
CAINS-MAP, mean (SD)	20.3 (8.7)
Engagement metrics
Number of days the app was opened, mean (SD)	41.0 (12.7)
Number of days participant checked in, mean (SD)	38.0 (13.8)
Adherence
Proportion of therapeutic lessons completed, mean (SD)	77.4 (29.3)
Number of therapeutic goals completed, mean (SD)	3.7 (2.1)

Abbreviations: CAINS-MAP, Clinical Assessment Interview for Negative Symptoms – Motivation and Pleasure subscale; MAP-SR, Motivation and Pleasure Self-Report Scale; MDPQ, Motivation and Deficit Questionnaire; SD, standard deviation.

Overview of Findings

Participants with moderate-to-severe ENS of schizophrenia shared feedback about their experience using the CT-155 beta app for 7 weeks. Feedback revealed insights in 3 overall domains: (1) the usability of the app (ease of use, flexibility, accessibility and enjoyability, engagement), (2) benefits of using the app (coping skills, social interest and skills, new ways of thinking, accomplishment), and (3) considerations for implementation (technical issues and literacy, personalization, content, impact of symptoms). A summary of key themes and subthemes, along with illustrative quotes, is provided in Table 2.

Theme 1: Usability of the CT-155 Beta App

First, in response to open-ended questions about their experience using the study app, many participants described their overall experiences as user-friendly and engaging. Their accounts reflected a strong appreciation for the intuitive design, adaptable structure, and emotionally supportive content. Specifically, participants discussed 4 aspects of usability that contributed to their positive experience using the app: (1) ease of use, (2) flexibility, (3) accessible and enjoyable content, and (4) feeling engaged and satisfied.

Ease of Use

Participants found the app user-friendly, highlighting their ability to use it without instruction or prior experience. The self-explanatory prompts and smooth flow between steps were seen as enablers of engagement: “It was basically self-explanatory. Once I logged in, it asked me how my day was going, and then I would click how I was doing, and then it would just [say] ‘You're doing a wonderful job.’ And then click to go to the next step” (ID11).

Another participant, who identified as having limited digital skills, appreciated how the app helped them develop new habits: “It was one of the easiest apps I’ve ever really dealt with because I really am not computer-inclined or phone-inclined, but the app showed me how to text more often and do more messaging, stuff like that so I could stay in touch with my support group” (ID23).

Other participants reflected on the structure of the app, and ways this supported them in slowing down and finding motivation, for example: “I’d say it was [easy to use], not to go over your head, but I think it was pretty easy for me to slow my roll down to get some type of different type of motivation of life” (ID16). Similarly, another participant commented on the app’s smooth transitions, noting that the experience felt calm and unrushed: “… how it transitions you through each phase, I think it was smoothly done. It wasn’t a rushed thing” (ID22).

Flexibility

Participants also discussed the flexibility offered in the app as a key feature that contributed to a positive experience. Those who mentioned flexibility highlighted 2 main aspects: (1) being able to postpone activities on difficult days and (2) having choices about the type and timing of tasks. Participants noted that these benefits were particularly valuable when they wished to make changes based on their mental health or other challenges they were facing on a given day. For instance, 1 participant discussed appreciating the option to pause the program when their mood was low and resume the next day: “If you’re having not a good day, you don’t have to do it this day at this time … you’ll be able to try it again tomorrow. I like that part” (ID19). Other participants discussed the benefits of being able to adapt their goals within the structure of the app, and this flexibility helped keep them engaged. For instance, 1 participant explained: “You had choices. What type of activity would you like to do? And then, would you like to do it for 20 minutes? ... So if you like writing … we’ll write. [Or] we’ll listen to music” (ID25).

Accessible and Enjoyable Content

As individuals reflected on their experience using the app, many described their engagement as enjoyable and accessible. Several remarked that they enjoyed using the app more than they expected to when they first heard about the tool: “It’s a really good app. I really enjoyed it. It kind of was sad when it ended, but it was pretty good. I did like my pace[d] breathing” (ID4). A separate participant spoke about the unexpected depth of engagement, describing how they often lost track of time while immersed in creative tasks:

It kept me on there for 2 hours a day for about a week or so. So yeah, it was like, for example, “Would you like to paint, draw, write a paragraph, or listen to music?” I say, “Well, listen to music and write” … it was cool. I mean, I wasn’t expecting to stay on the app for 2 hours a day for a week, but it went by fast. And I actually enjoyed myself. I found myself really not even paying attention to the clock. (ID30)

According to participants, the structure of the app’s guidance struck a helpful balance when motivating them to take steps toward their goals. For example, 1 individual described how the app helped them build confidence and autonomy by encouraging, and not instructing, them to try new activities: “I overall liked the app. It helped build my confidence in people, just being able to go out and do things. And it wasn’t like they were telling me to do it. They asked me to try” (ID11). Another participant highlighted the app’s helpfulness in managing emotions and planning ahead, particularly praising the tone and clarity of its voice guidance: “Well, it helped me keep track of my emotions and my anxiety. It’s very supportive, the voice of the app that talks . . . [and] it’s very easy to keep track with, like what we’re going to do the next day or in a week or a month maybe” (ID40).

Participants also described how the content of the app provided an alternative to their current standard of care. For 1 participant, the app offered a preferable alternative to traditional therapy, particularly in the context of disrupted services during the COVID-19 pandemic: “I’ve had therapists before, but since when the COVID came, it just threw everything out of whack. So now I have a therapist … but I’d rather deal with the app” (ID23). Another participant reflected on the calming quality of the app, noting that while it did not replace clinical care, it offered a peaceful, supportive experience that felt inviting: “I found it simple, and I found it relaxing … it does not replace a clinician, but … it was just all at ease, all well. And I’m going to say fun is not the word for it, but it was pleasant to go to the app” (ID25).

Felt Engaged and Satisfied with Experiences on the App

Many participants expressed a sense of personal engagement with the app that grew over time as they used it. Several individuals described their experience as more rewarding than they had initially anticipated. For instance, 1 participant reflected positively on their involvement, stating that the outcome exceeded their expectations: “I really got a lot out of it, more than I had expected I would, and I’m very well pleased with the experience” (ID20). Another participant commented on the program’s duration, noting that they were becoming increasingly engaged as it ended, and wished it had been extended: “The study was kind of short. It should have been longer … oh, the audio was cool … the whole thing needs to be longer because I was just really getting into it. Too short. The study was too short” (ID33).

The sources of felt engagement seemed to come from a variety of aspects of the app. For example, the visual and aesthetic aspects of the app appeared to support engagement for some. One such participant described the interface as “vibrant” and visually appealing: “I think the colors, it’s very vibrant, I guess. So it’s very … alluring to look at” (ID40). Others pointed to how they felt when using the app and referencing its content: “And when I use my cell phone, it actually gives me something. Pre-programmed my mind with good, positive imagery so I can actually boost up my self-esteem and my self-confidence, dignity, and respect for other people” (ID38).

Theme 2: Benefits of Using the App

This theme captures the positive psychological, social, and cognitive outcomes participants associated with engaging in the app. Specifically, the benefits identified fell within 4 areas: (1) development of coping skills, (2) increased social interest and skills, (3) new ways of thinking, and (4) a sense of accomplishment.

Coping Skills

Many participants expressed that the app was instrumental in learning coping skills for daily challenges related to schizophrenia and expressed how the app offered both practical and emotional strategies for managing stress, regulating emotions, and promoting day-to-day well-being. Of note, participants identified a range of skills they connected to and benefited from. For some individuals, relaxation techniques were highlighted as helpful to cope with their symptoms, “to relax … it teach[es] you some skills to cope with your schizophrenia … it was kind of fun” (ID28). For other individuals, engagement in structured daily tasks helped calm their racing thoughts and supported emotional regulation: “Sometimes my mind seems to go so fast … they learned me how to pace myself and do an activity … it kept me from really being inside of myself” (ID4).

Participants also identified real-world application of the coping skills they learned through the app, including better coping in stressful moments and greater confidence to face challenges. For example, 1 such participant reported improvements in self-expectations and their daily routine, attributing these changes to the coping skills learned from the app, such as meditation and focused breathing, contributed to a sense of calmness and readiness for future challenges:

I’ve actually learned how to get up before 10 o’clock every morning. I look forward to participating in your program. I actually learned a lot of coping skills … how to meditate and breathe, because sometimes I can’t hear my own heartbeat … and I got in tune with my inner being. And I feel like I’ve learned a great lot of assets I could use in the near future when I’m looking for a job, feel calm and cool, be able to stay focused and take good care of myself. (ID38)

For another user, the app prompted greater openness and helped reinforce the idea that support from others could be a valuable resource: “... it helped me open up a little bit more, try to talk to people more. It reminded me of other people who could help you with your stresses and coping” (ID17).

Social Interest and Skills

Many participants also reported improvements in their social skills and interest in socializing. The changes included overcoming withdrawal, initiating small gestures, or rediscovering everyday social skills. One participant shared that the app helped reduce their habitual isolation and encouraged them to reach out to others: “I learned how to socialize with my cellphone, and it actually brought me out of my inner shell, which I normally stay focused on myself every day” (ID38). Another described how small moments of positivity generated by the app prompted them to consider social interaction: “I liked that it made me smile. It made me want to find other people to talk to just instead of the ones I was talking to” (ID17).

Others expressed that the app prompted self-reflection about longstanding social patterns or helped rebuild confidence in engaging with others. Participants contrasted the social successes they experienced while using the app with their usual patterns of socialization, attributing these improvements to social skills they acquired through app use: “It teaches you how to properly talk to somebody or how to go out into the world and say hi. All this stuff I already knew 20, 30 years ago. [laughter] … But they teach you … stuff on it was cool” (ID27). One person noted that the app helped them initiate small, socially positive behaviors—like smiling or greeting others, which had fallen out of habit: “Trying to break the ice to speak to somebody that kind of opened me up a little bit because I just had this cloud over me and didn’t really want to sometimes deal with certain things … [then] when I spoke to somebody, it kind of made me feel a little bit better” (ID15).

Some participants also reported the app’s emotional regulation tools, such as breathing exercises or guided prompts, supported their ability to interact with others more calmly and deliberately; for example, “It taught me how to pace and breathe, take a moment to collect myself. And it taught me how to relax and my curiosity” (ID4). Another participant similarly shared:

It actually showed me how to overcome some of my residual symptoms by teaching me self-discipline. And I noticed that I do have bad habits and I have good habits. And my bad habits is I have a lot of negativity. And my positive energy that I have to develop is … maybe reach out and touch base with other individuals that might be more than willing to be my close friend. (ID38)

Finally, 1 participant suggested that this kind of gentle social stimulation could be particularly useful for those experiencing depression or isolation: “I think this is a real good app for loneliness because somebody who doesn’t interact, they have something to interact with” (ID22).

New Ways of Thinking

Individuals also discussed ways the app offered practical cognitive strategies—ranging from reframing negative thoughts to structured planning, to self-affirmation—that expanded how they approached daily challenges and emotion regulation. Participants were able to describe the specific strategies they employed from the app, and how these tools were useful in generating new ways of thinking that they adopted in everyday life.

Similar to the themes about coping strategies, participants identified a range of tools from the app that they found useful when it came to changing thought patterns. For instance, 1 participant valued prompts that redirected attention away from anticipated rejection toward curiosity and pleasant activities: “I found it helpful, informative, especially the part about curiosity and not dwelling on negative thoughts of rejection … To go out and try new things that would be pleasurable … and replacing thoughts” (ID2). Another described learning cognitive techniques for spotting “black-and-white” thinking (ID40), while others connected with the daily mirror exercises and self-affirmations that prompted a shift toward gratitude: “Every morning, I always got in the mirror and talked to it, talking to myself, actually, just letting me know I’m going to have a good day. I mean, it makes you be more grateful for you to face another day without too many challenges” (ID39).

Sense of Accomplishment

Participants also highlighted ways the app facilitated goal setting and task completion, which contributed to a personal sense of accomplishment, satisfaction, and left them feeling motivated. For instance, engaging with the app itself was an accomplishment for some, and they felt proud of their follow-through. One such participant described how completing small tasks contributed to a feeling of daily progress: “It made me feel good that I accomplished something for the day” (ID5). Such reflections suggest that, for some users, the app helped instill a routine that fostered self-discipline, goal-tracking, and emotional satisfaction tied to completing tasks. Achieving goals with the app also appeared to increase motivation. As 1 participant describes: “It’s fun. It excites. It’s usable. And then it’s a task … and then I just concentrate … and then I devote myself to it and then get the task done to put everything on the app” (ID42). Some participants also described engagement through internalizing what they learned from the app, noting how they planned to put their learnings into practice as they worked toward goals outside of the research study. One participant described how the app provided guidance that could help them move toward their personal goals: “For me, I think the app will help me out. If the app, in a way, like the study I just completed, it will help me. It will give me pointers. Give me good pointers. It will lead me the right way to complete my goal” (ID32).

Theme 3: Considerations for Implementation

While participants spoke positively about many aspects of the app, they also raised a range of practical considerations for future implementation including: (1) technical issues and digital literacy, (2) desire for greater personalization, (3) content suggestions, and (4) symptom impact on app use.

Technical Issues and Literacy

Some participants reported experiencing technical issues, such as log-in difficulties or notification delays. While these problems did not prevent use entirely, they occasionally interrupted engagement in the short term. In some cases, participants also reported difficulty knowing how to resolve technical issues that arose. For example, some participants experienced technical issues with the app notification system and relied on setting their own alarms as reminders rather than using the in-app function. One participant reported the notifications came through at the wrong time and they needed to restart their phone to fix the timing, but they were unsure how to create a long-term solution (ID30). Other examples of technical issues included receiving a reminder at a scheduled time even if they completed the task earlier in the day (ID8), and the app running slowly or taking time to load on one’s phone (ID32). Finally, 1 participant noted difficulties with password management and logging in: “I remember this time I didn’t do it that day. And I opened it up … I couldn’t figure it out myself … it asked for like a 5-digit password or something, and I couldn’t remember it. So, when I got here, I had to recreate a new one” (ID20).

Greater Personalization

Two participants described a desire for more tailored experiences within the app. While they acknowledged that the app was helpful, they felt that its structured options sometimes limited its relevance to the specific challenges they were facing. One person reflected on moments when the app felt emotionally supportive, but still wanted greater ability to tailor the app’s content:

I wish it would have had—being a little bit open to ideas that I had, like suggestions . . . If I was having a particular problem, I could type in what I was exactly going through that day or that moment instead of just giving me either this or that . . . an option where I compare as far as how is my mood today? Do you feel down? Do you feel up? (ID15)

This participant elaborated on the idea of more adaptive content, suggesting the app could benefit from branching pathways that respond to issues like suicidal ideation, domestic stress, or experiences of discrimination: “… say, if you’re having suicidal thoughts, it’ll take you to the suicidal page or the suicidal part of it and maybe try to get you some help, or give you pointers on domestic stuff that you’re going through” (ID15). A second participant recommended incorporating initial questions about their personality and preferences to make them feel more understood, enabling a dynamic interaction based on user input:

Ask me questions that I think are helpful, and let me give my feedback on what I think is helpful. Let’s say, for example, it asks me questions about my personality. Then it’s like, “Okay, it took time to get to know me.” Now it asks me, “What do you think we can do? Do you think that—what activities do you think will be helpful for this app?” So, if I say writing out my feelings, it allows me now to write out my feelings on the app. (ID41)

Content Suggestions

The feedback reflected a range of ideas for improving the app’s look, feel, and relational tone. Views varied, with some emphasizing the importance of information and coping strategies over visuals and others feeling the visual design enhanced their engagement. For example, 1 participant highlighted that they were seeking practical coping mechanisms for daily challenges, and thus the content of the app was what was most important to them: “I did the app to learn about coping mechanisms for what I deal with every day. So visually, it’s really not that important. It’s the content that’s inside the app that’s very important” (ID10).

In contrast, another user spoke positively about the animated journey sequences and how these supported motivation:

What I did really like in the app was in the beginning, when it had the little animations of you going on your journey to this new area or camp … and I really enjoyed that little character and his animations and depicting this hypothetical journey. And I don’t know. I just feel like the visuals helped a lot. (ID8)

There were also suggestions for making the experience feel more personal and relatable. One participant recommended including real people instead of animations, feeling it would make the content easier to connect with: “. . . a real person giving me advice about the breathing and things like that, that would be much better visually and more easy to connect” (ID10). Another expressed a need for more diverse representation of the app’s characters to ensure inclusivity: “More characters, it shows that anybody can do it, no matter what race, creed, color. I would love to see all race of characters in this app” (ID23).

Symptoms Impacting App Use

Finally, in 2 cases, content from participants appeared to suggest that mental health symptoms, such as paranoia, disorganization, or cognitive difficulties, may have impacted participants’ ability to engage with the app as intended. One participant reflected on how concerns about privacy and the perceived repetition of questions influenced their interaction with the app:

If we ask a question three times the same way, I probably repeat it … but I did not do that part the way it was supposed to do because I don’t have no people that are going to answer my question, like [a] family member. I talk my personal privacy with them, and then that’s it. And then I take it from there. (ID42)

Another described difficulty staying on topic when responding, and expressed awareness of how their disorganized thinking might affect communication:

And even though my responses are vague and sometimes completely just off-topic and I sometimes just give a one-word sentence, that one word just gives a clear example of how my mind is like a little off—or sometimes an entire sentence that had nothing to do with what we were asking you … I know that I have issues … you have to make sense of it because I start drifting away. (ID41)

Discussion

This qualitative analysis explored the experiences of individuals with schizophrenia with at least moderate ENS using CT-155 beta for a period of 7 weeks. Drawing on in-depth interviews conducted at the end of an exploratory study, the analysis identified 3 key themes: usability of the app, benefits of use, and considerations for future implementation. These findings provide insight into how users interacted with CT-155 beta, what aspects they found meaningful, and areas for further refinement.

The findings of this analysis highlight that usability was central to ensuring the app addressed the unique needs of people with schizophrenia with negative symptoms. Participants emphasized the importance of intuitive navigation, low cognitive load, and simple transitions between tasks. Several individuals, with self-described limited digital literacy, found the app easy to use and self-explanatory, indicating that co-design effectively minimized common engagement barriers. Flexibility with the app, such as the ability to pause, repeat, or tailor the timing of activities, may be particularly useful for people with schizophrenia who traditionally struggle with avolition. These features are particularly important for individuals with schizophrenia who experience cognitive impairment. These findings are in accord with self-determination theory⁵⁷ and illustrate how satisfying a patient’s sense of autonomy, competence, and relatedness may enhance engagement, encouraging feelings of intrinsic motivation toward the treatment. More specifically, flexibility in app use may empower users with a sense of autonomy over their therapeutic journey; progress tracking and adaptive goal setting may promote feelings of competence; and opportunities to share experiences and feel heard during the development process may create an emotionally resonant experience that can nurture feelings of relatedness. Future studies should examine whether fostering intrinsic motivation acts as a mechanism supporting app engagement.

In terms of perceived benefit, participants described several ways the app contributed to emotional and behavioral improvements. These included greater awareness of coping strategies, increased social engagement, and the use of structured routines to support daily activity. Some participants reported renewed motivation and greater engagement in personally meaningful activities. For individuals with schizophrenia who often have challenges around the initiation and completion of goal-directed behavior and intrinsic motivation, these findings emphasize the value of integrating these symptoms in vivo. Our findings suggest that CT-155 may help address key priorities identified by people living with schizophrenia for future treatments (eg, supporting relationships, enhancing enjoyment of daily activities, and improving motivation).²⁶ Participants’ satisfaction with the app’s content and format further supports the alignment between its design and patient needs, reinforcing the importance of patient-centered development and the integration of patient perspectives in accordance with regulatory guidance. Importantly, participants were ineligible if they had received psychotherapy within 12 weeks of study screening, yet they reported a range of perceived emotional and behavioral benefits, suggesting that CT-155 may offer support for individuals who are not currently engaged in traditional therapy. Finally, the experiences described by participants reflect CT-155’s theoretical foundation, particularly its focus on promoting goal-directed behavior and enhancing pleasure during daily activities.

Participants also shared a range of feedback related to future development and implementation. Some technical issues were reported, such as delays in notification delivery and occasional login difficulties. For individuals experiencing avolition, reliable reminders and prompts may be essential to facilitate engagement. Other DTx studies have also reported technical issues, such as login difficulties, reduced battery life, compatibility issues, and connecting to Bluetooth, which caused participants to feel frustrated spending time to resolve them.⁴⁵ These findings highlight the importance of having easy access to support so that technical issues are resolved quickly and any impact on engagement is minimized. Addressing such technical shortcomings could enhance the therapeutic value of the intervention. A few individuals suggested that more personalization would improve the user experience, particularly for those navigating complex emotional or environmental challenges. Feedback on app content also revealed diverse preferences: While some users appreciated visual simplicity, others wanted more animation, real-person guidance, or representation of diverse identities. Furthermore, in line with other studies, 1 individual reflected on concerns with privacy using the DTx.⁴⁵ Therefore, as with any digital intervention, it is crucial that patients are made fully aware of who has access to the app data. These perspectives informed updates to CT-155 for its ongoing phase III evaluation, which includes enhancements in content flexibility and user feedback mechanisms.

This study is subject to several limitations. First, the findings are based on a small number of qualitative interviews conducted at the end of a clinical study and may not be generalizable to all users of digital interventions or to broader clinical populations. Participants who completed the study and agreed to be interviewed demonstrated slightly higher engagement levels than the overall enrolled population. However, these differences were modest, and because the majority of participants completed the interviews, the interviewed group remained broadly representative of the full sample. Data also reflect short-term experiences within a structured research environment and may not capture how users would interact with the app in routine care. Furthermore, the feedback from users was considerably more positive than negative, and while this positive valence is a reflection of experiences shared by the participants, it’s also possible that there was a bias toward positive responses among those who agreed to take part in the interviews. Additionally, because interviews were only conducted with participants who completed the study, the qualitative findings may not fully represent the perspectives of those who did not complete the study. However, as this group comprised only 7 of the 50 enrolled participants, the impact on overall findings is likely to be limited. Finally, as noted in our methods section, participants were excluded if they had additional prominent disorders that might interfere with compliance to protocol, including PTSD, bipolar disorder, or major depressive disorder. Therefore, the results may not generalize to those with schizophrenia who also struggle with other complex conditions.

Conclusion

These results underscore the value of integrating patient experience data early in the development of a DTx, as they reveal the diversity of different perspectives and unique needs within the target population. The findings are in accord with self-determination theory and show how satisfying a patient’s sense of autonomy, competence, and relatedness may enhance engagement. For people living with schizophrenia, especially those affected by negative symptoms, intuitive, accessible, and personalized digital tools like CT-155 may offer a way to complement existing treatment approaches. At this point in time, there are few studies that have specifically focused on the user experience of digital treatments targeting negative symptoms. As such, the findings from this study may provide actionable insights for other developers and researchers working to create digital treatments for people with schizophrenia, who want to understand the unique app design considerations that must be kept in mind for this population and the motivational and engagement-related challenges among those with negative symptoms. Negative symptoms remain among the most disabling and difficult to treat features of schizophrenia, with limited pharmacological and psychosocial options that are both effective and scalable.^8,9,58,59 As a DTx intended to be prescribed in routine clinical care, CT-155 may help overcome accessibility and implementation challenges for evidence-based psychosocial treatments for schizophrenia. As CT-155 progresses through later-stage clinical testing, including the phase III CONVOKE study (NCT05838625), this work lays the foundation for a patient-informed, scalable intervention aligned with regulatory expectations. In other words, by centering the lived experiences of individuals with schizophrenia, this research advances the development of DTx that are not only clinically grounded but also meaningfully responsive to patient needs, and represents a promising step toward bridging the gap between scalable innovation and personalized care in mental health treatment. Future research should examine differences in engagement with the app based on clinical or background characteristics, as well as clinical effectiveness, long-term use patterns, and strategies to support sustained engagement of CT-155 in real-world settings.

Funding

This work was supported by Boehringer Ingelheim. Editorial support in the form of initial preparation of the manuscript with input from all the authors, and collation and incorporation of author feedback to develop subsequent drafts, assembling tables and figures, copyediting, and referencing was provided by Sarah Meadows, MRes, and Jonnie Plumb, PhD, of Avalere Health Global Limited, and was funded by Boehringer Ingelheim International GmbH.

Conflicts of Interest

J.B. and G.M. are employees of Click Therapeutics, Inc. C.D.C. and S.P. are employees of Boehringer Ingelheim International GmbH. A.G., B.D.H., B.P., and A.P. are employees of Boehringer Ingelheim Pharmaceuticals, Inc. A.P. is also affiliated with King’s College London, London, UK, Boston University, Boston, USA, and the University of Washington, Seattle, WA, USA. R.F. and L.L. have no conflicts to declare. G.S. is one of the original developers of the Brief Negative Symptom Scale (BNSS) and receives royalties and consultation fees from WCG in connection with commercial use of the BNSS and other professional activities; these fees are donated to the Brain and Behavior Research Foundation. G.S. has also received honoraria and travel support from WCG for training pharmaceutical company raters on the BNSS, and has consulted for and/or been on the speaker bureau for Minerva Neurosciences, Acadia, Lundbeck, Sunovion, Boehringer Ingelheim, Otsuka, and Johnson and Johnson pharmaceutical companies.

Data Availability

To ensure independent interpretation of clinical trial results and enable the authors to fulfil their role and obligations under the ICMJE criteria, Boehringer Ingelheim grants all external authors access to relevant clinical trial data. In adherence with the Boehringer Ingelheim Policy on Transparency and Publication of Clinical Study Data, scientific and medical researchers can request access to clinical trial data, typically, 1 year after the approval has been granted by major regulatory authorities or after termination of the development program. Researchers should use the link https://vivli.org/ to request access to trial data and visit https://www.mystudywindow.com/msw/datasharing for further information.