Developing a core outcome set for generalized anxiety disorder during the perinatal period: Identifying core treatment outcomes in perinatal anxiety

Abstract

Background

Generalized anxiety disorder during the perinatal period (pGAD) is highly prevalent and associated with adverse outcomes for both mother/birthing person (BP) and child. Yet, most treatment studies rely on researcher‐selected outcomes that may not reflect patient priorities.

Objectives

This study aimed to identify patient‐oriented treatment outcomes for pGAD to inform the development of a core outcome set (COS).

Design

A qualitative study using focus groups was conducted in line with COMET and COREQ guidelines to capture patient perspectives on treatment outcomes.

Methods

Six semi‐structured focus groups were conducted with participants who had a primary diagnosis of and participated in a cognitive behavioural therapy group for pGAD at the Women's Health Concerns Clinic, St. Joseph's Healthcare Hamilton. Discussions explored participants' experiences with perinatal anxiety, specifically which treatment outcomes were most important to them when seeking treatment for pGAD. Focus groups were audio‐recorded, transcribed verbatim and analysed using thematic analysis with independent coding and consensus validation.

Results

A total of 21 participants (10 pregnant, 11 postpartum) were recruited. Three overarching themes were identified: (1) emotional well‐being, (2) interpersonal and relational well‐being and (3) daily functioning. Within these themes, the treatment outcomes most important to people with lived experience with pGAD were reported: increased self‐awareness, management of distressing thoughts, partner relationship satisfaction, validation through support, improved sleep quality and overall quality of life.

Conclusions

Patient‐identified outcomes extend beyond symptom reduction and highlight the importance of psychological resilience, partner relationship satisfaction and functional recovery. Incorporating these outcomes into future treatment will enhance the relevance, comparability and clinical utility of interventions for pGAD, supporting the development of a patient‐informed COS.

Practitioner points.

• pGAD is highly prevalent and associated with negative outcomes for both mothers/birthing people and the child.

• A COS ensures that treatment uses consistent and patient‐oriented treatment outcomes, improving comparability across studies.

• Patient involvement in identifying outcomes helps ensure that interventions address the needs and priorities of perinatal populations.

• Findings from this study will support researchers and clinicians in evaluating and selecting treatment outcomes that are most meaningful to pregnant and postpartum people with GAD.

INTRODUCTION

Generalized anxiety disorder (GAD) is a chronic anxiety disorder characterized by persistent, excessive and difficult‐to‐control worry that lasts for a period of at least six months. It is accompanied by cognitive, emotional and somatic symptoms that cause clinically significant distress or impairment in functioning. In the perinatal context, GAD often presents with pregnancy and parenting‐related worries, including fears about childbirth, infant health and safety, parenting ability and family well‐being. This presentation of GAD during the perinatal period (pGAD) can manifest as heightened reassurance‐seeking, hypervigilance and impairments in daily caregiving roles (Fairbrother et al., 2016; Wenzel & Stuart, 2011).

The perinatal period refers to the time spanning pregnancy and the postpartum period, typically defined as pregnancy through the first 12 months following childbirth (Wenzel & Stuart, 2011). GAD is the most commonly diagnosed anxiety disorder during the perinatal (pregnant and the postpartum) period, with a prevalence rate of 4% in pregnant people and 5.7% in postpartum people, compared with 1.8% in non‐perinatal populations (Dennis et al., 2017; Ruscio et al., 2017). This is concerning as untreated GAD in this population is associated with significant distress and impairment in functioning of the mother/birthing person (mother/BP), and poor cognitive, emotional and developmental outcomes for the child (Grigoriadis et al., 2018; Stein et al., 2012; Uguz et al., 2013).

The high prevalence rate of GAD during the pGAD highlights the importance of clinical research studies that evaluate the effectiveness of interventions for pGAD. Specifically, it is critical to ensure that we are providing this population with the most effective and evidence‐based treatments, and we must conduct high‐quality clinical treatment studies. This entails choosing both well‐defined outcomes and valid and reliable outcome measurement instruments (Williamson et al., 2017). To determine the most effective evidence‐based treatment options for people with pGAD, the results of high‐quality treatment studies must be compared against one another through systematic reviews (Williamson et al., 2017).

One problem in many areas of health research is that different researchers are measuring different outcomes with different measurement instruments (Williamson et al., 2017). This leads to ‘Research Waste’, namely, an unfortunate process whereby many research studies/outcomes are excluded from systematic reviews due to the variability in outcomes that are measured across studies (Chalmers et al., 2014). Another problem that exists in health research is that outcomes are often chosen by the researchers/trialists. As a result, the treatment outcomes that matter most to the end users, that is, the patients/consumers, are often left unknown and/or not taken into consideration, and ultimately, not measured (Williamson et al., 2017). There has been a growing awareness of the importance of patient engagement in outcome selection and measurement in clinical treatment studies, resulting in a strong emphasis on quality of life and functional outcomes being two critical treatment outcomes to evaluate (Sacristan et al., 2016).

We conducted a scoping review following a systematic approach to identify the outcomes and outcome measurement instruments that are being utilized in studies evaluating interventions for GAD during the perinatal period. Our results suggest there is a significant amount of variability in both the outcomes and outcome instruments that are being utilized across these studies. Further, the researchers solely chose and defined the outcomes that were measured in these clinical treatment studies, leaving outcomes that matter most to the end users (e.g., patients) unknown.

To enable comparability through clinical treatment studies, core outcome sets (COS; Williamson et al., 2017) are developed for use in many health care areas, resulting in the standardization of outcome selection and measurement across clinical treatment studies of a particular condition. COS also enables the synthesis of these studies through systematic reviews. A COS is an agreed‐upon, standardized, minimum set of outcomes that should be measured and reported in all clinical treatment studies of a specific health condition, while allowing researchers to also measure other outcomes of interest (COMET Initiative, 2022).

The primary objective of this study was to identify the treatment outcomes that matter the most to people with pGAD. These outcomes were identified through focus groups that were conducted with people with lived experience of pGAD (Sim, 1998). Consistent with the exploratory and qualitative nature of this study, we hypothesized that people with lived experience of pGAD would identify treatment outcomes that extend beyond symptom reduction and prioritize domains related to daily functioning, quality of life, emotional well‐being and caregiving capacity. We further hypothesized that these patient‐identified outcomes would not fully align with the outcomes most commonly selected and reported by researchers in existing clinical treatment studies.

This study is part of the development of an evidence‐ and consensus‐based COS for studies that evaluate the effectiveness of any type of intervention for people with pGAD.

METHODS

Design

This study followed the Core Outcome Measures in Effectiveness Trials (COMET) Initiative methodology recommendations. This included the recommended identification of outcomes that matter the most to patients in the Core Outcome Set development process. The 32‐item checklist Consolidated criteria for REporting Qualitative research (COREQ) was followed (see the Appendix Table A1; Tong et al., 2007). As part of the patient and public involvement recommendations of the COMET methodology, we conducted focus groups with those who have pGAD to understand what treatment outcomes matter the most to this patient population (Krueger & Casey, 2015; Williamson et al., 2017).

Participants

Mothers/BP who were 18 years old or older, pregnant or up to 12 months postpartum, with a primary diagnosis of GAD, had completed cognitive behavioural therapy (CBT) for pGAD treatment. CBT was selected as it is a first‐line, evidence‐based intervention for GAD, including during the perinatal period, and is widely used in both clinical practice and research. Therefore, understanding how outcomes are measured in CBT‐based interventions is essential for ensuring consistency and comparability across studies. Participants who were fluent in English and had completed a full course of CBT for pGAD were recruited to participate in the focus groups. Treatment completion was defined in advance as attendance at all six sessions of an evidence‐based CBT group protocol for pGAD delivered at the Women's Health Concerns Clinic (WHCC) in Hamilton, Ontario. Participants with comorbid disorders were also included as long as their principal diagnosis was GAD. Participants with neurological disorders, mania, psychosis, or current substance and alcohol use disorders were excluded.

Recruitment and consent procedure

Participants were patients of the WHCC in Hamilton, Ontario, who were recruited to participate in research at their initial consultation. This is a specialty outpatient clinic that provides mental health care to women across the reproductive timeline (e.g., perinatal, menopause; Caropreso et al., 2020). Patients who were referred for group CBT for pGAD completed a semi‐structured assessment to confirm the diagnosis of pGAD (i.e., the Mini‐International Neuropsychiatric Interview for the DSM‐V; Sheehan et al., 1997). The CBT intervention consisted of a six‐session, manualized group CBT protocol specifically adapted for pGAD and grounded in well‐established evidence‐based CBT principles for anxiety disorders, including psychoeducation, cognitive restructuring, worry management and behavioural strategies. Only individuals who completed all six CBT sessions were eligible for inclusion in the present study, ensuring that all participants had been exposed to the full treatment protocol prior to participation in the focus groups. Patients were invited to participate in a prospective database that allows researchers in the clinic to utilize their data (e.g., assessment outcome, symptom measures), granting permission to be contacted for future studies (Hamilton Integrated Research Board (HiREB) #: 1052). The research team identified participants in this database who have a principal diagnosis of GAD and who have completed group CBT treatment. The eligible participants from the database were contacted via telephone to describe the purpose of the study and, the time commitment, while emphasizing the study's importance (e.g., ensuring future research studies investigating the effectiveness of GAD interventions during the perinatal period incorporate treatment outcomes that matter most to patients). Both verbal and written consent were obtained (written via email attachment), and the participant was provided with an opportunity to time to ask any questions or voice any concerns. Participants who consented to participate in the research were then scheduled to participate in a focus group via a virtual Zoom format.

Focus group procedure

Focus groups were conducted on the Zoom virtual platform and were scheduled to last for up to 1.5 h. Two female PhD candidates in clinical psychology who were part of the research team (ES, BI) led the blinded semi‐structured focus groups to gain qualitative insights into which outcomes for GAD interventions during the perinatal period are most important for pregnant and postpartum people. To ensure consistency across sessions, all focus groups were conducted using a standardized semi‐structured guide. Co‐facilitators followed the same scripted introduction, sequence of core questions, and facilitation procedures in each session. During focus group sessions, research team members took field notes of participant responses. Focus group participants were aware that the facilitators of the focus group were experts in the perinatal field. A patient partner was engaged to review and refine outcome definitions for clarity and relevance; however, this individual's input was intended to supplement, rather than replace, the broader perspectives obtained through focus groups and the existing perinatal mental health literature, and should not be interpreted as representing all patient viewpoints. The focus groups were audio recorded using the Zoom recording function, and a physical recording device was used for redundancy. Zoom's auto‐transcription service was used to create the initial transcript file, and the file was cross‐referenced against the recordings to ensure the transcript is verbatim. Finally, the transcript was reviewed for accuracy by two independent reviewers (AT, DG).

The first 15 min of the group included introductions and a brief overview of the study goals and how the focus group would take place. Participants were then asked the following questions. The research team members further probed with questions when necessary to elicit further information and/or when necessary to secure detailed responses (Braun et al., 2019; Braun & Clarke, 2006; Maguire & Delahunt, 2017):

1. Tell us about your experiences with anxiety before and during the perinatal period. When did it start and how has it impacted you? The goal of this question was to gain insight into their experience and build rapport with one another.

2. When you participated in treatment for perinatal anxiety, what treatment outcomes were important to you? The goal of this question was for participants to come up with as many outcomes as possible that they were looking for when first seeking out treatment.

3. Considering the outcomes of treatment that were important to you, did treatment address these outcomes or were there outcomes that remained unchanged? Why do you think these outcomes did not change? The goal of this question was to identify outcomes that were important to the participants but may not have been addressed in treatment to ensure all outcomes were discussed.

4. Out of all the anxiety treatment outcomes you described, which ones are most important to you when seeking treatment for perinatal anxiety? This question was considered the most important question for this study. Once the participants had brainstormed all possible outcomes, they were asked which one, out of all the outcomes discussed, mattered the most to them.

Once the outcomes were identified, our research team collaborated with our patient partner (someone who completed treatment for GAD in our clinic in the past) to develop patient‐oriented definitions for each outcome, ensuring they reflected participants' experiences rather than relying solely on researcher‐derived definitions from the existing literature.

Sample size

We utilized one of the most common qualitative sampling methods, referred to as sampling until redundancy (i.e., saturation; Guest et al., 2006; Streiner et al., 2015). Retzer et al. (2020) conducted focus groups to identify patient‐derived outcomes to be used in community‐based bipolar trials. This study reached saturation with a sample of 21 participants (10 pregnant and 11 postpartum), informing our hypothesis that a minimum of 15 participants would be sufficient to achieve saturation. Participants were provided with a small token in the form of a gift card upon completion of the focus group for their time participating in this study.

Measures

Demographics form

The demographic information collected from participants included participants' age, gender, sex, number of months pregnant or postpartum while they were undergoing treatment, how far pregnant or postpartum they were currently, number of children, ethnicity, marital status, education level, employment status, medical history, pregnancy and delivery history, family psychiatric history, medication usage and treatment history.

Mini‐International Neuropsychiatric Interview for the DSM‐V (MINI; Sheehan et al., 1997). The MINI, a semi‐structured diagnostic interview tool, was used to confirm a DSM‐V diagnosis prior to pGAD for each participant's treatment at the WHCC as part of the Green Prospective Database (HiREB #15085). The MINI is a valid and reliable clinician‐reported assessment tool (Lecrubier et al., 1997; Sheehan et al., 1997) and has demonstrated good concordance with other diagnostic interviews (Spitzer et al., 1990). Questions in the MINI ask about the intensity, frequency and duration of symptoms and the degree of distress and impairment associated with them. Participants in the current study were screened for manic and hypomanic episodes, major depression, persistent depression, GAD, panic disorder, agoraphobia, social anxiety, specific phobia, obsessive compulsive disorder, suicidality, posttraumatic stress disorder, substance and alcohol use and psychosis.

Data analysis

Statistical analysis

Means and percentages for continuous variables and means and standard deviations (for discrete variables) were calculated for relevant demographic scores for both pregnant and postpartum participants, to better characterize the sample (Table 1).

TABLE 1.

Participant demographic characteristics.

Variable	n	%	M	SD	Range
Gender
Women	21	100
Age (years)			31.76	4.35	22–40
Weight (lb)			184.24	53.33
Height (inches)			66.29	2.33
GAD onset
Perinatal	5	23.8
Outside Perinatal	15	71.4
Unreported	1	4.76
Number of children			1.00	.63
0/pregnant	4	19
1 child	13	61.9
2 children	4	19
Race
White	18	85.7
Other	1	4.8
Asian	1	4.8
East Asian	1	4.8
Marital status
Married	20	95.2
Single	1	4.8
Employment
Full time	14	66.7
Part time	3	14.3
STD/LTD	3	14.3
Unemployed	1	4.8
Education level
Bachelor's	8	38.1
Master's	5	23.8
Certificate	4	19
High school	4	19
Psychotropic medications
Yes	10	47.6
No	11	52.4
Medical conditions
Yes	7	33.3
No	14	66.7
Comorbid diagnoses
Mood disorders	14	66.7
MDD	10	47.6
PDD	1	4.8
PMDD	1	4.8
BD	1	4.8
Anxiety/related disorders	4	19
Panic disorder	1	4.8
Agoraphobia	1	4.8
Specific phobia	1	4.8
SAD	2	9.5
Both mood and anxiety disorders	4	19.0
None	6	28.6

Note: Some participants had both anxiety‐related and mood‐related comorbid diagnoses. Percentages may not total 100% due to rounding or overlap in comorbidities.

Abbreviations: BD, bipolar disorder; MDD, major depressive disorder; PDD, persistent depressive disorder; PMDD, premenstrual dysphoric disorder; SAD, social anxiety disorder.

Qualitative analysis

The qualitative focus group data were analysed using a thematic analysis to identify treatment outcomes that are most important to mothers/BP with GAD (Braun et al., 2019; Braun & Clarke, 2006; Maguire & Delahunt, 2017). Two independent coders from the research team (AT, DG) familiarized themselves with the data, conducted a preliminary code generation (i.e., initial codes identified), identified themes/outcomes across the data, reviewed the themes by cross‐checking with the other coder and discussed until a consensus was reached. If a consensus was not reached, a third review was consulted (ES) to examine the data and resolve the discrepancy through a group discussion. Following a consensus, a definition and name for each outcome were identified, using the existing literature to search for existing definitions.

To enhance transparency and reduce arbitrariness in outcome organization, these six participant‐derived outcomes were subsequently mapped onto the outcome domain framework proposed by Dodd et al. (2018). This framework provides a standardized and theoretically grounded taxonomy for organizing outcomes across studies. Mapping was conducted by the research team through discussion and consensus, with each outcome assigned to the domain that best reflected its conceptual focus. Using this approach, the six outcomes were organized into four overarching domains: psychological/emotional functioning, social functioning, life impact and physical functioning. Thus, the six focus groups informed the identification of six core outcomes, which were then structured into four overarching domains to facilitate clarity and comparability.

RESULTS

Demographic information

A total of 21 participants were included in the present study. Three individuals who initially expressed interest and were scheduled did not attend the focus groups and were therefore not included in the final sample. Among those who participated, there was 0% attrition. From the included participants (n = 21), all self‐identified as women, with 11 in the postpartum period and 10 currently pregnant. The majority identified as White (n = 18), with one participant identifying as Asian, one as East Asian and one as Other. Most participants were married (n = 20), and one participant identified as single. Participants ranged in age from 22 to 40 years (M = 31.76, SD = 4.35). A total of 13 participants reported having one child, 4 participants reported having two children and 4 participants reported having no children/were pregnant with their first child.

With respect to clinical characteristics, the onset of GAD occurred outside the perinatal period for most participants (n = 15), during the perinatal period for four participants (n = 5), and was not reported for one participant (n = 1). Fewer than half of the participants (n = 10) reported current use of psychotropic medication, and seven participants reported at least one medical condition. Among the 21 participants, 14 had a comorbid mood disorder, four had a comorbid anxiety‐related disorder and six did not have a comorbid diagnosis. Among the 18 individuals with a comorbid disorder, some participants (n = 4) experienced both mood and anxiety‐related disorders, indicating an overlap between categories. A full breakdown of participant demographics and clinical characteristics is presented in Table 1.

Study overview

Between March 2024 and October 2024, six focus groups were conducted to determine treatment outcomes that were valued as most important to perinatal mothers/BP with a primary diagnosis of GAD. Each focus group had an average of three participants, with attendance ranging from two to five participants per session. The average duration of these sessions was approximately 1 h and 29 min (range = 15 min).

The analysis identified several key themes representing changes in participants' emotional, psychological and behavioural states following the intervention, each reflecting important aspects of the participants' experiences and progress. Importantly, the six focus groups served as the source of qualitative data from which themes and outcomes were derived, rather than representing distinct analytic units.

Key findings from focus groups

Our key question from the focus group was: ‘Out of all of the anxiety treatment outcomes you described, which ones are most important to you when seeking treatment for perinatal anxiety?’

Our thematic analysis of the six focus groups identified six core treatment outcomes that participants described as most important when seeking treatment for pGAD: (1) increased self‐awareness, (2) management of distressing thoughts, (3) relationship satisfaction, (4) validation through support, (5) improved sleep quality and (6) quality of life. The most frequently reported outcome was Increased Self‐Awareness, followed by Quality of Life, then Management of Distressing Thoughts, Relationship Satisfaction, Validation Through Support and finally Improved Sleep Quality.

Rather than aggregating these outcomes into higher‐order themes inductively, we subsequently mapped them onto the established outcome domain framework proposed by Dodd et al. (2018). This framework provides a standardized and theoretically grounded approach to organizing heterogeneous outcomes across studies. Using this framework, Increased Self‐Awareness and Management of Distressing Thoughts were categorized under ‘Psychological/Emotional Functioning’; Partner Relationship Satisfaction and Validation Through Support under ‘Social Functioning’; Quality of Life under ‘Life Impact’; and Improved Sleep Quality under ‘Physical Functioning’. This mapping is presented to enhance transparency, reduce arbitrariness in outcome aggregation and present the findings within an established outcomes taxonomy.

Domain 1: Psychological/emotional functioning

Outcomes in this category involve a desire for greater self‐awareness and improved management of distressing thoughts. Mothers/BP expressed a need to better understand their internal experiences, recognize cognitive patterns and develop strategies to navigate their thoughts more effectively. Strengthening these skills was seen as essential for fostering emotional resilience, enhancing cognitive flexibility and promoting a greater sense of control over one's mental well‐being.

Outcome 1a: Increased self‐awareness

Increasing self‐awareness is characterized by wanting to develop recognition of emotions and feelings of anxiety. It helps mothers/BP identify what anxiety feels like in their own lives, how it affects different areas of life and how it presents in specific situations. Beyond just recognizing emotional states and triggers, this also involves identifying physical and behavioural signs of anxiety early and taking steps to prevent them from escalating.

Quotes included:

I think for me having the tools for recognizing thought distortions, because I was aware of a few of them, but realized how many more affected me, or that I thought were normal were distorted. (Participant 1, Focus Group 5)

being mindful, aware and taking a step back where needed and learning coping strategies to be more healthy emotionally and mentally. (Participant 2, Focus Group 5)

Knowing how to acknowledge/accept the way you were feeling was an important step in feeling better, as well maybe being more compassionate with yourself. (Participant 1, Focus Group 6)

Outcome 1b: Management of distressing thoughts

Management of distressing thoughts outcome is characterized by the desire to process, recognize, understand and respond to unwanted, distressing thoughts in a way that reduces the impact on the emotions and daily lives of mothers/BP. It involves developing awareness of these thoughts and learning to engage in cognitive restructuring and/or accepting their presence without allowing them to take control. Effective management helps people minimize distress, maintain focus and engage in daily activities without being overwhelmed by intrusive thoughts.

Quotes included:

The biggest thing was the intrusive thoughts, it just got in the way of my sleep, got in the way of my joy, got in the way of like, yeah just everything. I feel like it was just all surrounded by these intrusive thoughts that would definitely I think be the biggest thing for me. (Participant 1, Focus Group 4)

Like I want to be able to control those thoughts and worries enough that I can be a good parent and help my own child be able to regulate and control their thoughts and emotions. I think that to a certain degree – I don't know, he's only four – but there's a certain part of me that thinks that the way I am has kind of produced a little bit of anxiety in him as well, and I would like to be able to show him coping mechanisms and use all those strategies that I've learned and will learn. (Participant 3, Focus Group 3)

Using some of my tools to calm my brain down and feel comfortable in my own body to face my fear, that was very helpful especially through that newborn no sleep, no focusing on our own needs kind of deal. (Participant 3, Focus Group 6)

Domain 2: Social functioning

Outcomes in this category involve a desire for meaningful connections, emotional validation and strengthened relationships. Mothers/BP expressed a need for support and understanding, particularly as they navigate the impact of anxiety on their relationships. They emphasized the importance of feeling heard, acknowledged and validated in their experiences, highlighting how emotional support from others fostered a greater sense of security and closeness. Feeling supported and understood was seen as essential for enhancing emotional well‐being and maintaining fulfilling interpersonal relationships.

Outcome 2a: Partner relationship satisfaction

Partner relationship satisfaction is characterized by the desire of mothers/BP to build stronger, more supportive relationships with their partners through communication. This includes feeling supported, comfortable expressing emotions and needs openly, fostering understanding and deepening their sense of connection despite feelings of a changed identity.

Quotes included:

The relationship with my spouse, would be like the number one thing. And, I don't think, like, I, I don't think that was really addressed much, if at all, in the CBT for anxiety group, and that was like a huge piece for me. (Participant 3, Focus Group 1)

Yes, definitely communication. My son's father is a bit of a hothead, so instead of communicating ‘I'm frustrated’, he just starts yelling., Why are you yelling at me? Why not just talk to me? (Participant 4, Focus Group 6)

Outcome 2b: Validation through support

Validation through support is characterized by mothers/BP wanting their experiences with having anxiety in motherhood to be recognized and understood by others who have been through similar challenges. The feeling of being understood and connected to others who have gone through similar situations. It involves recognizing shared emotions, challenges or circumstances, which can provide comfort, validation and a sense of belonging. In the context of mental health and motherhood, relatability fosters self‐trust, reassurance and empowerment in managing emotional challenges.

Quotes included:

Like I really wanted to have validation of a therapist saying like, “What you're going through is something we've seen before, this is something that's treatable, it's something that we can empathize with.” and also just kind of directly with other mothers. Being able to look at another woman and see another woman and just kind of know that we're in it together and that, again, you're just not alone. (Participant 2, Focus Group 3)

I think the main one was like a group therapy because I wanted to talk to somebody about similar situations. I had a bit in the past, and I was hoping to get the same now. I just like to know that other people out there are feeling the same way I am and that I am not going crazy. (Participant 2, Focus Group 6)

Domain 3: Life impact

Outcomes in this category include reducing the burden of anxiety and improving overall functioning to enhance sleep and quality of life. Participants expressed a desire to regain a sense of balance, emotional stability and presence in their daily lives. Many emphasized the importance of restful sleep in restoring energy, maintaining focus and supporting emotional resilience. They also sought to engage more fully in meaningful experiences without being overwhelmed by distressing thoughts or persistent worry.

Outcome 3a: Quality of life

Quality of life is characterized by the level of functioning and how well a person feels in different areas of life. For mothers/BP, this includes their overall well‐being, both physically and mentally, as well as their relationships, environment and daily experiences. It reflects their desire to feel emotionally stable, balanced and fulfilled in their everyday lives.

Quotes included:

I, really just wanted to lower my level of anxiety so that I could have more enjoyment throughout the day. Like I feel like my anxiety was so all‐consuming, that I feel, I just felt like I couldn't enjoy the simple things in life. (Participant 3, Focus Group 2)

I would say that it would be just the lessening of the overwhelming feelings that I would get. Like, you know, daily tasks would just kind of end up feeling like way too much. (Participant 2, Focus Group 3)

Domain 4: Physical functioning

This domain captured physiological outcomes associated with anxiety, particularly sleep disruption, which participants described as both a consequence and an amplifier of anxiety.

Outcome 3b: Improved sleep quality

Improved sleep quality is characterized by a desire for more restful, uninterrupted sleep that enhances overall well‐being. For mothers/BP, it involves reducing sleep disturbances caused by anxiety, managing racing thoughts or nighttime worries and developing strategies to promote relaxation before sleep. Improving sleep disrupted by anxiety leads to better emotional regulation, increased energy levels and improved daily functioning.

Quotes included:

I wanted to get more sleep, because my anxiety was stopping me from being able to sleep, which was amplifying that anxiety and being able to cope day‐to‐day. Sleep was a very discrete thing but also to stop spiraling or ruminating thoughts. (Participant 1, Focus Group 5)

I could never sleep. I could never turn off my mind—it felt like a million different things were constantly racing through my head. (Participant 1, Focus Group 1)

DISCUSSION

This qualitative study identified patient‐prioritized treatment outcomes for people with pGAD to inform the development of a patient‐oriented COS. Thematic analyses of six focus groups revealed four overarching domains that were mapped onto the theoretical framework from Dodd et al. (2018): (1) psychological/emotional functioning, (2) social functioning, (3) life impact and (4) physical functioning. Within the four overarching domains, six main treatment outcomes emerged that participants considered the most important when seeking treatment for pGAD: (1) increased self‐awareness, (2) management of distressing thoughts, (3) partner relationship satisfaction, (4) validation through support, (5) improved sleep quality and (6) overall quality of life. Importantly, the domains reported reflect a higher‐order organization of participant‐derived outcomes identified across all focus groups. These findings reveal a critical gap between what people with pGAD value and what existing research measures, challenging the field to move beyond symptom reduction as the primary endpoint.

Current randomized controlled trials for perinatal anxiety predominantly measure symptom severity using standardized scales such as the Generalized Anxiety Disorder‐7 (GAD‐7), State–Trait Anxiety Inventory (STAI) and Edinburgh Postnatal Depression Scale (EPDS), with diagnostic remission as a secondary endpoint (Adouard et al., 2005; Cox et al., 1987; Green et al., 2020; Li et al., 2022; Spitzer et al., 2006; Surkan et al., 2024). While these measures capture symptom change, they fail to assess the functional, relational and experiential outcomes that patients identify as most meaningful. For instance, systematic reviews of perinatal anxiety interventions rarely include quality of life, partner relationship satisfaction, or self‐awareness as primary or secondary outcomes (Singla et al., 2021). This disconnect between researcher‐selected and patient‐prioritized outcomes may explain why many evidence‐based interventions demonstrate statistical efficacy but limited clinical significance in real‐world settings (Edgman‐Levitan & Schoenbaum, 2021).

The literature demonstrates that aligning treatment outcomes with patient priorities improves treatment engagement, reduces dropout rates and enhances clinical outcomes (Kristensen et al., 2025; Windle et al., 2020). Meta‐analyses also show that when patients receive their preferred treatment or are involved in shared decision‐making, they show higher treatment satisfaction and increased completion rates (Lindhiem et al., 2014; Windle et al., 2020). Our findings extend this literature by identifying which specific outcomes matter most to individuals with pGAD, providing an empirical foundation for developing a patient‐oriented COS.

Why these outcomes matter

Self‐awareness is key in metacognitive models of anxiety because noticing and reflecting on one's thoughts and emotions supports adaptive emotion regulation. This may be especially important in the perinatal period, when rapid adjustment to new roles and demands makes it easier to feel overwhelmed (Halaj et al., 2024). Greater self‐awareness can facilitate coping and help‐seeking.

Similarly, partner relationship satisfaction is also a protective factor. Meta‐analyses show that emotional closeness, strong communication and satisfaction reduce the risk for perinatal anxiety and depression, whereas conflict increases it. For patients with pGAD, relationship strain can amplify anxiety at a time when couples are navigating infant care, sleep deprivation and role transitions, making relationship quality a potentially modifiable determinant of maternal mental health (Dennis & Ross, 2006; Martin & Brock, 2023; Pilkington et al., 2015).

Sleep quality is also very important. Longitudinal evidence indicates that postpartum insomnia and poor sleep uniquely predict higher anxiety and depressive symptoms across the first six months postpartum (even after accounting for prenatal sleep). More fragmented sleep is also associated with greater anxiety, making sleep a modifiable outcome with direct effects on daily functioning and emotion regulation (Basu et al., 2024; Okun & Lac, 2023; Palagini et al., 2023).

Finally, validation through support matters because perinatal anxiety is often minimized as ‘normal’ pregnancy worry. Feeling heard by providers, partners and peers can reduce stigma, normalize help‐seeking and strengthen the therapeutic alliance.

Implications for practice and research

This study demonstrates that people with pGAD prioritize outcomes that extend beyond symptom reduction, with an emphasis on relational, functional and metacognitive domains. While prior research has highlighted maternal–infant bonding and partner relationships as domains of interest, few studies have examined how these shape patients’ judgements of whether treatment is effective (de Waal et al., 2023). By focusing on lived experiences, our study suggests that evaluations of pGAD interventions should explicitly account for outcomes such as daily functioning, emotional resilience, perceived validation and support, relationship quality, sleep and self‐efficacy in managing worry, rather than focusing solely on symptom severity.

These findings have direct implications for the development of a COS in pGAD. COS should incorporate patient‐prioritized outcome domains alongside symptom‐based measures, including functional participation in daily life, relational well‐being, emotional coping capacity and perceived control over worry (Stallwood et al., 2023). Including these domains would ensure that COS better reflects what patients define as meaningful involvement while providing a more comprehensive standard for evaluating intervention effectiveness (Stallwood et al., 2023).

Building on these findings, future trials should prioritize validated, reliable patient‐reported outcome measures (PROMs) that capture not only symptom change but also functioning, quality of life, emotional well‐being and patient‐defined outcomes (Kingsley & Patel, 2017; Lavallee et al., 2016). Importantly, PROMs should be sensitive to change, feasible across settings and aligned with the relational and functional priorities identified by participants, with greater use of individualized or goal‐oriented measures to ensure that outcomes such as validation, coping and relational improvements—often overlooked by symptom‐focused scales—are meaningfully captured (Lavallee et al., 2016).

These findings also support a shift in how trial endpoints are defined in pGAD research. Rather than treating symptom reduction as the sole or primary endpoint, future trials should consider multi‐domain endpoints or include patient‐prioritized outcomes as key secondary or co‐primary endpoints. Such approaches would better capture meaningful treatment benefits and improve the interpretability of trial findings for patients, clinicians and decision makers.

In clinical practice, these results depict the importance of integrating patient‐prioritized goals into routine care for pGAD. Clinicians can operationalize this by using PROMs to support shared goal‐setting, monitoring outcomes that patients identify as meaningful over time and tailoring interventions to address relational functioning, daily life participation and coping skills in addition to symptom management. Thus, embedding patient‐prioritized outcomes into care has the potential to enhance engagement, strengthen care relationships and align treatment successes with outcomes that matter most to patients.

Strengths and limitations

This study has several strengths. The in‐depth qualitative design enabled the collection of rich, detailed accounts from people with lived experience of pGAD, offering insight into the treatment outcomes they value most. The use of semi‐structured focus groups allowed for both structure and flexibility, ensuring that key domains were explored while also giving participants the freedom to raise outcomes that may be overlooked in standardized assessments (Braun & Clarke, 2006; Maguire & Delahunt, 2017). This format facilitated the emergence of diverse perspectives and contributed to a more comprehensive understanding of patient‐identified outcomes. Thematic analysis was conducted using a consensus‐based approach with two independent coders, increasing the reliability of findings and reducing individual coder bias (Braun & Clarke, 2006). Additionally, the study was guided by best practices in outcome set development, including adherence to COMET and COREQ guidelines (Tong et al., 2007; Williamson et al., 2017), and incorporated meaningful stakeholder engagement, including collaboration with patient partners to ensure materials were accessible, relevant and appropriate for the target population.

The study is not without limitations. First, as this study relied on focus group discussions, participant responses may have been shaped by group dynamics, including social desirability bias and conformity effects (Bergen & Labonté, 2020; Júnior, 2022). Participants may have emphasized outcomes perceived as socially acceptable or aligned with group norms, while underrepresenting more stigmatized or personally sensitive experiences. Although the use of a skilled facilitator and an emphasis on shared experiences aimed to mitigate these dynamics, they cannot be fully eliminated and may have influenced the prioritization of certain outcomes (Bergen & Labonté, 2020; Júnior, 2022).

Second, the generalizability of these findings to other populations with pGAD requires careful consideration. As participants were drawn from a specific clinical and social context, it is important to recognize that outcome priorities may differ across cultural, socioeconomic, or healthcare settings. For example, relational‐focused outcomes may carry different salience in contexts with varying family structures, social supports, or models of perinatal care. Consequently, the outcomes identified here should be considered as being contextually grounded rather than universally representative of all individuals with pGAD.

Third, selection bias may have influenced the findings, as individuals who chose to participate in focus group discussions may differ systematically from those who did not (Smart, 1966; Tripepi et al., 2010). Participants may have been more engaged in their care, more reflective about their experiences, or more comfortable discussing mental health in group settings. However, individuals experiencing more severe symptoms, limited social support, or greater barriers to participation may be underrepresented, thereby potentially shaping the range and framing of outcomes discussed (Smart, 1966; Tripepi et al., 2010).

Fourth, the absence of comparison groups limits the ability to assess whether the outcome priorities identified are specific to pGAD or reflect broader experiences shared across perinatal mental health conditions. Without comparison to individuals with other perinatal mood or anxiety disorders, or to those without a clinical diagnosis, it is not possible to determine the extent to which these priorities are disorder‐specific as opposed to cross‐diagnostic.

Finally, these limitations have implications for the generalizability of the findings to COS development. While this study provides in‐depth insight into patient‐prioritized outcomes, COS development typically requires input from diverse stakeholder groups and settings. The outcomes identified here should therefore be viewed as an important foundational contribution that requires integration with evidence from additional populations and perspectives to ensure broader applicability.

CONCLUSION

This study identifies patient‐prioritized outcomes to inform the development of a COS for pGAD. Overall, participants described meaningful treatment success as extending beyond symptom reduction to broader improvements in self‐awareness, management of distressing thoughts, relationship functioning, validation through support, sleep and overall quality of life. These outcomes were organized across four key domains, highlighting the multidimensional nature of recovery in pGAD. By centring patient perspectives, these findings reveal a critical misalignment between symptom‐focused outcome measurement and how people with pGAD define meaningful improvement. This work underscores the need for future research and clinical practice to move beyond symptom severity as the primary endpoint and instead incorporate patient‐prioritized, functionally meaningful outcomes. Taken together, these findings provide a strong empirical foundation for the development of a patient‐informed COS and support a shift towards more relevant, comparable and clinically meaningful evaluation of pGAD interventions.

AUTHOR CONTRIBUTIONS

Emma M. Stallwood: Conceptualization; investigation; funding acquisition; writing – original draft; methodology; validation; visualization; writing – review and editing; formal analysis; project administration; data curation. Annaba Tasnia: Data curation; formal analysis; writing – review and editing; writing – original draft. Daniela Giansante: Data curation; formal analysis; writing – review and editing; writing – original draft. Briar E. Inness: Methodology; validation; writing – review and editing. Benicio N. Frey: Methodology; writing – review and editing; supervision; formal analysis; validation. Randi E. McCabe: Methodology; validation; writing – review and editing; formal analysis; supervision. Sheryl M. Green: Methodology; validation; writing – review and editing; resources; formal analysis; supervision; project administration; investigation.

FUNDING INFORMATION

This study was supported by an unrestricted grant from the Shoppers Drug Mart Run for Women (#7738200516).

CONFLICT OF INTEREST STATEMENT

The authors have no conflicts of interest to declare.

APPENDIX A.

A.1.

TABLE A1.

Consolidated criteria for reporting qualitative studies (COREQ): 32‐item checklist. ^a

No.	item	Guide questions/description	Manuscript reference
Domain 1: Research team and reflexivity
Personal characteristics
1.	Interviewer/facilitator	Which author/s conducted the interview or focus group?	Methods—Focus Group Procedure
2.	Credentials	What were the researcher's credentials? e.g., PhD, MD	Title Page
3.	Occupation	What was their occupation at the time of the study?	Methods—Focus Group Procedure
4.	Gender	Was the researcher male or female?	Methods—Focus Group Procedure
5.	Experience and training Relationship with participants	What experience or training did the researcher have?	Methods—Focus Group Procedure
6.	Relationship established	Was a relationship established prior to study commencement?	Methods—Focus Group Procedure
7.	Participants' knowledge of the interviewer	What did the participants know about the researcher? e.g., personal goals, reasons for doing the research	Methods—Focus Group Procedure
8.	Interviewer characteristics	What characteristics were reported about the interviewer/facilitator? e.g., bias, assumptions, reasons and interests in the research topic	Methods—Focus Group Procedure
Domain 2: Study design
Theoretical framework
9.	Methodological orientation and Theory	What methodological orientation was stated to underpin the study? e.g., grounded theory, discourse analysis, ethnography, phenomenology, content analysis	Data Analysis—Qualitative Analysis
Participant selection
10.	Sampling	How were participants selected? e.g., purposive, convenience, consecutive, snowball	Methods—Recruitment Procedure
11.	Method of approach	How were participants approached? e.g., face‐to‐face, telephone, mail, email	Methods—Recruitment Procedure
12.	Sample size	How many participants were in the study?	Methods—Recruitment Procedure
13.	Non‐participation	How many people refused to participate or dropped out? Reasons?	Methods—Sample Size
Setting
14.	Setting of data collection	Where was the data collected? e.g., home, clinic, workplace	Methods—Recruitment Procedure
15.	Presence of non‐participants	Was anyone else present besides the participants and researchers?	Methods—Recruitment Procedure
16.	Description of sample	What are the important characteristics of the sample? e.g., demographic data, date	Methods—Participants
Data collection
17.	Interview Guide	Were questions, prompts, or guides provided by the authors? Was it pilot tested?	Methods—Focus Group Procedure
18.	Repeat interviews	Were repeat interviews carried out? If yes, how many?	Methods—Focus Group Procedure
19.	Audio/visual recording	Did the research use audio or visual recording to collect the data?	Methods—Focus Group Procedure
20.	Field notes	Were field notes made during and/or after the interview or focus group?	Methods—Focus Group Procedure
21.	Duration	What was the duration of the interviews or focus group?	Methods—Focus Group Procedure
22.	Data saturation	Was data saturation discussed?	Methods—Focus Group Procedure
23.	Transcripts returned	Were transcripts returned to participants for comment and/or correction?	Methods—Focus Group Procedure
Domain 3: Analysis and Findings
Data analysis
24.	Number of data coders	How many data coders coded the data?	Data Analysis—Quantitative Analysis
25.	Description of the coding tree	Did the authors provide a description of the coding tree?	Data Analysis—Quantitative Analysis
26.	Derivation of themes	Were themes identified in advance or derived from the data?	Data Analysis—Quantitative Analysis
27.	Software	What software, if applicable, was used to manage the data?	Data Analysis—Quantitative Analysis
28.	Participant checking	Did participants provide feedback on the findings?	Data Analysis—Quantitative Analysis
Reporting
29.	Quotations presented	Were participant quotations presented to illustrate the themes / findings? Was each quotation identified? e.g., participant number	Results—Key Findings from Focus Groups
30.	Data and findings consistent	Was there consistency between the data presented and the findings?	Data Analysis—Quantitative Analysis
31.	Clarity of major themes	Were major themes clearly presented in the findings?	Data Analysis—Quantitative Analysis
32.	Clarity of minor themes	Is there a description of diverse cases or a discussion of minor themes?	Data Analysis—Quantitative Analysis

^a Table referenced from Tong et al. (2007).

DATA AVAILABILITY STATEMENT

The data that support the findings of this study are available on request from the corresponding author, pending completed data sharing agreement. The data are not publicly available due to privacy or ethical restrictions.