Digital Cognitive Behavioral Treatment for Generalized Anxiety Disorder: A Randomized Clinical Trial

E Marie Parsons; Tali Ball; Jenna Carl; Alasdair L Henry; Richard Emsley; Christopher B Miller; Eileen Y Wong; Emily Coombs; Daniel Collins; Laura J Long; Anca Chis Ster; Jasper A J Smits; Michael W Otto

doi:10.1001/jamanetworkopen.2025.48884

. 2025 Dec 15;8(12):e2548884. doi: 10.1001/jamanetworkopen.2025.48884

Digital Cognitive Behavioral Treatment for Generalized Anxiety Disorder

A Randomized Clinical Trial

E Marie Parsons ^1,^✉, Tali Ball ², Jenna Carl ², Alasdair L Henry ², Richard Emsley ³, Christopher B Miller ², Eileen Y Wong ², Emily Coombs ¹, Daniel Collins ¹, Laura J Long ¹, Anca Chis Ster ³, Jasper A J Smits ⁴, Michael W Otto ¹

¹Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts

²Big Health Inc, San Francisco, California

³Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King’s College, London, United Kingdom

⁴Department of Psychology, The University of Texas at Austin

Accepted for Publication: October 23, 2025.

Published: December 15, 2025. doi:10.1001/jamanetworkopen.2025.48884

Open Access: This is an open access article distributed under the terms of the CC-BY-NC-ND License, which does not permit alteration or commercial use, including those for text and data mining, AI training, and similar technologies. © 2025 Parsons EM et al. JAMA Network Open.

^✉

Corresponding Author: E. Marie Parsons, PhD, Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave, 2nd Floor, Boston, MA 02215 (mariepar@bu.edu).

Author Contributions: Drs Parsons and Emsley had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Parsons, Ball, Carl, Henry, Emsley, Miller, Otto.

Acquisition, analysis, or interpretation of data: Parsons, Ball, Henry, Emsley, Wong, Coombs, Collins, Long, Chis Ster, Smits, Otto.

Drafting of the manuscript: Parsons, Ball, Henry, Emsley, Coombs, Collins, Otto.

Critical review of the manuscript for important intellectual content: All authors.

Statistical analysis: Emsley, Chis Ster.

Obtained funding: Parsons, Otto.

Administrative, technical, or material support: Parsons, Ball, Henry, Wong, Coombs, Collins, Otto.

Supervision: Parsons, Carl, Henry, Long, Smits, Otto.

Conflict of Interest Disclosures: Dr Parsons reported receiving grants from Big Health Inc during the conduct of the study. Dr Ball reported having stock options in Big Health Inc. Dr Henry reported owning stock and having stock options in Big Health Inc. Dr Emsley reported receiving consultancy fees from Big Health Inc payable to King’s College London during the conduct of the study and personal fees from Big Health Inc outside the submitted work. Dr Miller reported having stock options in Big Health Inc during the conduct of the study. Ms Coombs reported receiving grants from Big Health Inc during the conduct of the study. Mr Collins reported receiving grants from Big Health Inc during the conduct of the study. Dr Long reported receiving grants from Big Health Inc during the conduct of the study. Dr Smits reported receiving personal fees from Boston University for consulting on the grant that funded the study; receiving personal fees from Big Health Inc for work as a clinical consultant during the conduct of the study; receiving grants from the National Institutes of Health, Cancer Prevention and Research Institute of Texas, US Department of Defense, and Trauma Research and Combat Casualty Care Collaborative for research on the intervention development; receiving personal fees from the American Psychological Association for editorial activities; and receiving royalties from Elsevier, Springer, and Oxford University Press outside the submitted work. Dr Otto reported receiving grants from Big Health Inc during the conduct of the study and personal fees from Big Health Inc outside the submitted work; receiving grant support from the National Institute of Mental Health, National Institute on Drug Abuse, and National Institute on Aging; and receiving royalties for book publications from Oxford University Press. No other disclosures were reported.

Funding/Support: This study was funded and supported by Big Health Inc.

Role of the Funder/Sponsor: The design and prespecified statistical analysis plan for this trial were led by the sponsor, Big Health Inc. Drs Parsons and Otto controlled final decisions for interpretation and manuscript writing. The sponsor contributed to the study design in collaboration with the academic investigators, provided access to both study interventions, and funded study operations, including data collection and statistical analyses conducted by independent biostatisticians. Researchers employed by the sponsor coauthored the final manuscript in collaboration with the academic investigators. The academic investigators completed all evaluations, were responsible for data interpretation, and made the final decision to submit the manuscript for publication.

Data Sharing Statement: See Supplement 3.

Additional Information: This trial supported US Food and Drug Administration clearance of DaylightRx (clearance number K233872) as a digital therapeutic intended to treat generalized anxiety disorder in adults aged 22 years or older as an adjunct to usual care.

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Corresponding author.

PMCID: PMC12706682 PMID: 41396602

This randomized clinical trial investigates the efficacy of a smartphone-delivered digital cognitive behavioral therapy intervention compared with psychoeducation for treating generalized anxiety disorder symptoms in adults.

Key Points

Question

Can a smartphone-delivered digital cognitive behavioral therapy (DCBT) intervention treat and maintain reductions in generalized anxiety disorder (GAD) symptoms better than an active control condition?

Findings

In this randomized clinical trial involving 351 adults with GAD, a smartphone-delivered DCBT yielded greater anxiety reduction and remission rates at posttreatment follow-up compared with psychoeducation.

Meaning

The findings suggest that offering CBT in a smartphone-delivered digital format is effective for the treatment of GAD in adults.

Abstract

Importance

Generalized anxiety disorder (GAD) is a chronic and disabling condition. Although cognitive behavioral therapy (CBT) is a first-line treatment for GAD, access to this treatment is limited; digital CBT (DCBT) programs may have the potential to overcome barriers to effective treatment and expand therapist reach and impact.

Objective

To evaluate the effectiveness of smartphone-delivered DCBT compared with an active psychoeducation control condition for the treatment of GAD.

Design, Setting, and Participants

This single-blind, parallel-group, decentralized randomized clinical trial with 1:1 allocation was conducted between March 8, 2023, and February 28, 2024. Procedures for this fully remote national study were conducted through Boston University. Participants were adults aged 22 years or older who scored 15 or higher on the 7-item Generalized Anxiety Disorder (GAD-7) scale and met diagnostic criteria for current GAD.

Intervention

A self-directed, tailored DCBT for GAD designed to be used flexibly for efficient learning of CBT techniques via smartphone. The control condition was an online psychoeducation intervention.

Main Outcomes and Measures

Primary outcomes were remission status as determined by a blinded independent evaluator (assessed with the Clinical Global Impressions–Improvement [CGI-I] scale) and self-reported anxiety symptom severity (assessed with the GAD-7), evaluated at the primary end point at 10 weeks and the secondary end point at 24 weeks.

Results

A total of 351 adults were randomized (175 DCBT, 176 psychoeducation; mean [SD] age, 40.6 [10.9] years; 259 [73.8%] women). Significantly lower GAD-7 scores were found for DCBT (Cohen d, 1.09 [95% CI, 0.81-1.37] at week 10 and 0.96 [95% CI, 0.67-1.24] at week 24). Additionally, 103 of 145 DCBT participants (71.0%) met remission status (assessed by the CGI-I) at 10 weeks compared with 54 of 156 psychoeducation participants (34.6%) (odds ratio [OR], 4.63; 95% CI, 2.85-7.54; P < .001); remission occurred in 115 of 148 participants (77.7%) for DCBT and 78 of 150 (52.0%) for psychoeducation at 24 weeks (OR, 3.22; 95% CI, 1.95-5.32; P < .001).

Conclusions and Relevance

In this randomized clinical trial, DCBT provided significant and sustained benefits to adults with GAD. Given the limitations in access to empirically supported CBT, an efficacious DCBT program has clear potential for public health benefit.

Trial Registration

ClinicalTrials.gov Identifier: NCT05748652

Introduction

Generalized anxiety disorder (GAD) is a chronic condition characterized by excessive, persistent, and uncontrollable anxiety about a variety of life areas.¹ With a lifetime prevalence of 6%,² GAD is associated with reduced quality of life, impaired social and occupational functioning, and increased health care utilization.^3,4,5,6

Cognitive behavioral therapy (CBT) and pharmacotherapy are first-line interventions for GAD.^7,8 CBT offers the advantages of a match with patient preference for psychosocial treatment⁹ as well as strong tolerability, efficacy, and cost efficacy.^9,10,11,12 Nonetheless, CBT may be less accessible due to systematic barriers such as limited numbers of trained therapists, burden of in-person therapy, and stigma.^13,14

Digital interventions have been proposed to overcome these barriers and allow practitioners to efficiently expand their reach to more patients.¹⁵ Smartphones have been identified as a promising format for care delivery, given they are ubiquitous and offer real-time access. Yet, early meta-analytic evaluations of smartphone-delivered interventions for anxiety¹⁵ have indicated ample room for improvement that might be achieved by better-designed applications that distill key CBT principles into digital-friendly formats while encouraging clinical skill application.

A smartphone-delivered digital CBT (DCBT), DaylightRx, was designed to address this need and has shown promise for the treatment of GAD. In a previous randomized clinical trial of adults with moderate-to-severe GAD symptoms, large effects were observed for this DCBT relative to a waiting list control at 10 weeks (Cohen d = 1.43).¹⁶ Building upon this work, the current trial tested the DaylightRx DCBT relative to an online psychoeducation control¹⁷ in adults with interview-confirmed GAD. Psychoeducation was selected as the control condition because it has been shown to be a credible intervention with documented benefits exceeding the placebo effect.^17,18 Psychoeducation also matches DCBT on several important features; both are delivered digitally, are self-guided with content self-paced over time, and require participants to act on the information provided in order to achieve benefit. We hypothesized that compared with psychoeducation, DCBT would result in lower patient-reported anxiety symptoms and higher clinician-rated remission rates at 10 and 24 weeks following randomization.

Methods

Design

The current study was a 2-arm, parallel, decentralized blinded randomized clinical trial comparing DCBT with digital psychoeducation in adults with GAD. The trial was conducted between March 8, 2023, and February 28, 2024. All procedures after recruitment were conducted through Boston University, approved by the Boston University institutional review board, and reviewed by a data and safety monitoring board. Written informed consent from participants was obtained electronically. The trial followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.¹⁹ The trial protocol is provided in Supplement 1.

Participants

Participants were adults aged 22 years or older who (1) met diagnostic criteria for GAD based on a standardized interview²⁰; (2) scored 15 or higher on the GAD-7 scale, indicating symptoms in the “severe” range²¹; (3) resided in the US; (4) were fluent in English; (5) had access to the internet via a mobile or tablet device; and (6) were able and willing to adhere to the protocol. The age inclusion criterion for this study was informed by the Food and Drug Administration Center for Devices and Radiological Health, which considers individuals younger than 22 years to be pediatric.²² Participants were excluded if they (1) were currently receiving or expecting to start psychological treatment for anxiety or had received CBT or acceptance and commitment therapy for anxiety in the past 6 months; (2) if taking psychotropic medication, had not maintained a stable dosage for at least 60 days; (3) had a history of psychosis, schizophrenia, bipolar disorder, or current obsessive compulsive disorder; (4) had alcohol or substance use disorder of moderate or greater severity within the past 12 months; (5) had moderate or greater suicide risk; (6) had hearing or vision impairment; (7) had intellectual disability or neurocognitive or neurodevelopmental disorder; and/or (8) had any condition that the investigator believed would make participation in the study not in the best interest of the participant or would preclude successful completion of study activities.

Race and ethnicity, ascertained by self-report, were included in the analysis to characterize the sample. Categories were Asian, Black, Latinx/Hispanic, Middle Eastern/North African, Native American/Indigenous, Pacific Islander/Native Hawaiian, White, and multiracial.

Procedures

Participants were recruited nationally in the US through online advertisements; screening was completed via an online self-report questionnaire followed by a video screening visit to confirm eligibility. At the outset of the screening visit, study procedures were explained and e-consent was obtained; to reduce fraudulent enrollment, participant identity was confirmed using a valid form of photo identification. Subsequently, eligible participants were asked to complete a baseline assessment and were then assigned to their treatment condition.

Participants assigned to anxiety program 1 (intervention) received access to a DCBT mobile application (DaylightRx) for generalized anxiety.^16,23,24 The DCBT delivered a digital formulation of evidence-based CBT techniques—cognitive restructuring, applied relaxation, stimulus control, avoidance reduction, mindfulness, problem solving, and imaginal exposure—taught through interactive lessons and guided practices. The program was self-paced and encouraged regular use and implementation in daily life.

Participants assigned to anxiety program 2 (control) received access to evidence-based psychoeducation for anxiety self-management through a written online format. The information included education on the symptoms, prevalence, causes, and consequences of GAD and advice relating to lifestyle changes (eg, increased sleep and exercise) individuals could make that might improve anxiety. As with program 1, program 2 was self-paced, and participants were encouraged to regularly revisit and apply the material to their daily lives.

Following randomization, all participants received reminders prompting them to access and complete their assigned treatment program. Although duration of use varied, participants were expected to complete their assigned program by the 10-week end point. There were no restrictions on usual care for either arm. Participants completed online self-report questionnaires at 6 weeks, 10 weeks, and 24 weeks postrandomization and video visits with a blinded independent evaluator at 10 weeks and 24 weeks. Participants received gift cards up to $130 for their time spent completing assessments and were given access to the alternate anxiety program following study completion. Participants retained access to both programs for 1 year.

Randomization and Masking

Participants were randomized 1:1 to DCBT or psychoeducation using a web-based randomization function with a static block size of 6 immediately following the baseline assessment. The sponsor, principal investigators (E.M.P., M.W.O.), study staff, assessors, and statisticians were blinded to allocation. Participants were blinded to the hypothesis; the interventions were labeled as anxiety program 1 and 2, with the potential for benefit from either program indicated in the study information and the consent form. There were 8 unblinding events, all in the DCBT arm; sensitivity analyses confirmed robustness of the findings when excluding these participants.

Measures

GAD diagnosis for inclusion was established using the Mini International Neuropsychiatric Interview (MINI) for the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition).²⁰ Exclusions for comorbidity and suicidality were established using the MINI and the Columbia–Suicide Severity Rating Scale (C-SSRS), respectively. The 2 coprimary outcome measures, assessed at 10 weeks (primary end point) and 24 weeks (secondary end point) after randomization, were patient-reported anxiety symptoms on the GAD-7 scale (score range, 0-21, with higher scores indicating greater anxiety symptoms)²⁵ and remission assessed using the Clinical Global Impressions–Improvement (CGI-I) scale (score range, 1-7, with lower scores indicating greater improvement),²⁶ administered by blinded independent evaluators using a standardized rubric. Following recommendation from the literature²⁷ for reliability determination of CGI-I scores, evaluators rated symptom burden, distress, and impairment using a structured interview and compared these with baseline ratings to generate an improvement score from 1 (“very much improved”) to 7 (“very much worse”). Evaluators were trained to criteria prior to administering the measure, attended regular consensus meetings throughout the study, and were blinded to participant allocation. Remission was defined as CGI-I scores of 2 or lower. Secondary outcomes were depression symptoms (Patient Health Questionnaire–8 [PHQ-8]²⁸; score range, 0-24, with higher scores indicating greater depression symptoms), sleep problems (8-item Sleep Condition Indicator [SCI-8]²⁹; score range, 0-32, with higher scores indicating better sleep), and blinded-evaluator rated GAD severity (Clinical Global Impression–Severity [CGI-S] scale²¹; score range, 1-7, with higher scores indicating worse anxiety severity). Adverse events were proactively assessed by blinded raters during the 10-week and 24-week visits using a standardized set of questions, including the C-SSRS.

Statistical Analysis

Data analyses were conducted by external statisticians (R.E., A.C.S.) who were independent of the study team and blinded to the treatment condition received. No interim statistical analyses were performed. All analyses were conducted using Stata, version 18 (StataCorp LLC).³⁰ Study success criteria were prespecified and required both clinical and statistical significance for both coprimary outcome measures, as described in this section.

To examine the primary hypothesis that DCBT would result in higher remission rates compared with psychoeducation at 10 weeks, a logistic regression model was used to estimate the treatment effect, defined as the odds ratio (OR) between DCBT and psychoeducation for the CGI-I–based remission rates at 10 weeks. Robustness of results to missing data assumptions was also explored post hoc. Clinical significance was prespecified as an absolute increase in remission rate of 10% (eg, if the psychoeducation remission rate was 35%, a DCBT remission rate of ≥45% would be clinically significant).

To examine the primary hypothesis that DCBT would lead to lower patient-reported anxiety symptoms than psychoeducation at 10 weeks, a linear mixed-effects model of GAD-7 total scores at baseline, 6 weeks, and 10 weeks was used. Treatment, time point (categorical), time × treatment interaction, and prerandomization GAD-7 score were included as fixed effects. Participants were included as a random intercept to account for multiple outcomes per individual. The treatment effect was defined by the adjusted mean difference (AMD) between groups in GAD-7 scores at the end of the treatment period, adjusted for baseline scores. Clinical significance was prespecified as a between-group AMD greater than 2 points.

To examine the secondary hypothesis that gains would be maintained at 24 weeks, the statistical tests were repeated at this time point, using piecewise slopes in the linear mixed-effects model to allow a change in slope in the follow-up period. To determine if DCBT reduced secondary outcomes of depression (PHQ-8), sleep difficulties (SCI-8), or GAD symptom severity (CGI-S) relative to psychoeducation, linear mixed-effects models were conducted equivalently to the primary GAD-7 outcome. Linear mixed models for the continuous primary and secondary outcomes using maximum-likelihood estimation allowed analysis of all available data under a missing-at-random assumption, conditional on the variables in the model. Two-sided P < .05 was considered significant.

Sample size calculation was conducted using the sampsi function in Stata, version 17.0, based on a linear mixed-effects model of GAD-7 scores over time. To detect a minimum between-group effect of Cohen d = 0.30 with power at 90%, α of .05, 2 postbaseline repeated assessments, and a correlation among repeated measures of r = 0.3, 262 participants (131 per arm) with outcome data would be required. Assuming trial attrition of 25% resulted in requiring 350 participants to be randomized. The target number of participants to be randomized was adjusted when high retention was consistently observed in the trial (previously, 30% attrition was assumed). This updated target was approved by the data and safety monitoring board .

Results

The trial included 351 participants (175 randomized to DCBT and 176 to psychoeducation). Demographic information is in Table 1. A total of 88 participants (25.1%) were men, 259 (73.8%) were women, and 4 (1.1%) selected “other” gender (a write-in option); mean (SD) age was 40.6 (10.9) years. Eighteen participants (5.1%) were Asian, 29 (8.3%) Black, 22 (6.3%) Latinx/Hispanic, 2 (0.6%) Middle Eastern/North African, 2 (0.6%) Native American/Indigenous, 0 Pacific Islander/Native Hawaiian, 252 (71.8%) White, 25 (7.1%) multiracial, and 1 (0.3%) not specified. Eighty-five participants (24.2%) were taking medications for anxiety at screening, with nearly identical rates in the 2 groups (41 [23.4%] DCBT, 44 [25.0%] psychoeducation). Treatment initiation (168 [96.0%] DCBT, 172 [97.7%] psychoeducation) and study retention through the primary end point at 10 weeks (145 [82.9%] DCBT, 156 [88.6%] psychoeducation) were high in both arms (Figure 1).

Table 1. Baseline Participant Characteristics.

Characteristic	Participants, No. (%)
Characteristic	DCBT (n = 175)	Control (n = 176)	Full sample (N = 351)
Age, mean (SD), y	40.7 (11.2)	40.5 (10.6)	40.6 (10.9)
Gender
Men	41 (23.4)	47 (26.7)	88 (25.1)
Women	131 (74.9)	128 (72.7)	259 (73.8)
Other^a	3 (1.7)	1 (0.6)	4 (1.1)
Race and ethnicity^b
Asian	8 (4.6)	10 (5.7)	18 (5.1)
Black	16 (9.1)	13 (7.4)	29 (8.3)
Latinx/Hispanic	13 (7.4)	9 (5.1)	22 (6.3)
Middle Eastern/North African	1 (0.6)	1 (0.6)	2 (0.6)
Native American/Indigenous	1 (0.6)	1 (0.6)	2 (0.6)
Pacific Islander/Native Hawaiian	0	0	0
White	125 (71.4)	127 (72.2)	252 (71.8)
Multiracial	11 (6.3)	14 (8.0)	25 (7.1)
Not specified	0	1 (0.6)	1 (0.3)
Employment
Full-time employed	101 (57.7)	108 (61.4)	209 (59.5)
Part-time employed	19 (10.9)	16 (9.1)	35 (10.0)
Unemployed	18 (10.3)	23 (13.1)	41 (11.7)
Retired	11 (6.3)	5 (2.8)	16 (4.6)
Full-time student	6 (3.4)	5 (2.8)	11 (3.1)
Full-time homemaker or caregiver	20 (11.4)	19 (10.8)	39 (11.1)
Educational level
No formal qualifications	0	1 (0.6)	1 (0.3)
Secondary school or high school graduate	8 (4.6)	15 (8.5)	23 (6.6)
Some college	48 (27.4)	37 (21.0)	85 (24.2)
Undergraduate or bachelor’s degree	61 (34.9)	64 (36.4)	125 (35.6)
Postgraduate or professional degree	58 (33.1)	59 (33.5)	117 (33.3)
Marital status
Married	89 (50.9)	101 (57.4)	190 (54.1)
Divorced or separated	22 (12.6)	18 (10.2)	40 (11.4)
Never married	42 (24.0)	37 (21.0)	79 (22.5)
Partnered	20 (11.4)	18 (10.2)	38 (10.8)
Widowed	1 (0.6)	2 (1.1)	3 (0.9)
Prefer not to say	1 (0.6)	0	1 (0.3)
Annual household income, $
≤24 999	23 (13.2)	23 (13.1)	46 (13.1)
25 000 to ≤74 999	71 (40.6)	51 (28.9)	122 (34.8)
75 000 to ≤149 999	59 (33.7)	76 (41.2)	68 (38.5)
≥150 000	22 (12.6)	16 (14.8)	48 (13.7)
Medication use for anxiety at baseline	41 (23.4)	44 (25.0)	85 (24.2)

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Abbreviation: DCBT, digital cognitive behavioral therapy.

^{^a}

“Other” was a write-in option.

^{^b}

Categories are not mutually exclusive.

Figure 1. — DCBT indicates digital cognitive behavioral therapy; ITT, intention to treat.

Primary Outcomes

The coprimary, blinded-rater outcome showed a significant treatment advantage for DCBT (Figure 2), with 103 of 145 DCBT participants (71.0%) meeting remission status (CGI-I score ≤2 points) at 10 weeks relative to 54 of 156 (34.6%) in the psychoeducation arm (OR, 4.63; 95% CI, 2.85-7.54; P < .001). At 24 weeks, this advantage was retained, with 115 of 148 participants (77.7%) who received DCBT meeting remission status relative to 78 of 150 (52.0%) in the psychoeducation arm (OR, 3.22; 95% CI, 1.95-5.32; P < .001). Sensitivity analysis confirmed robustness to missing data under worst plausible assumptions (eTable 1 in Supplement 2).

Similar effects were found for the self-reported coprimary outcome (GAD-7 score) (Figure 3 and Table 2). Mean (SD) GAD-7 score at 10 weeks was 7.88 (4.76) for DCBT and 11.68 (4.42) for psychoeducation participants (Cohen d, 1.09; 95% CI, 0.81-1.37) and at 24 weeks was 7.23 (4.88) for DCBT and 10.68 (4.73) for psychoeducation participants (Cohen d, 0.96; 95% CI, 0.67-1.24). Participants who received DCBT had significantly lower GAD-7 scores than psychoeducation participants at every assessment point following baseline, reflecting large between-group effect sizes at weeks 6, 10, and 24 postrandomization.

Table 2. Primary and Secondary Continuous Outcomes Through 24 Weeks Postrandomization.

Measure	DCBT		Control		AMD (95% CI)	Cohen d (95% CI)	P value
Measure	Score, mean (SD)	Participants, No. (%) (n = 175)	Score, mean (SD)	Participants, No. (%) (n = 176)	AMD (95% CI)	Cohen d (95% CI)	P value
GAD-7^a
Baseline	15.58 (3.50)	175 (100)	16.14 (3.07)	176 (100)	NA	NA	NA
Week 6	8.82 (4.50)	159 (90.9)	12.45 (4.35)	170 (96.6)	3.42 (2.50 to 4.34)	1.04 (0.76-1.32)	<.001
Week 10	7.88 (4.76)	157 (89.7)	11.68 (4.42)	168 (95.5)	3.58 (2.66 to 4.50)	1.09 (0.81-1.37)	<.001
Week 24	7.23 (4.88)	156 (89.1)	10.68 (4.73)	166 (94.3)	3.15 (2.21 to 4.09)	0.96 (0.67-1.24)	<.001
PHQ-8
Baseline	11.91 (5.13)	175 (100)	12.31 (4.89)	176 (100)	NA	NA	NA
Week 10	8.56 (5.75)	158 (90.3)	11.13 (5.57)	169 (96.0)	−2.40 (−3.36 to −1.43)	0.48 (0.29-0.67)	<.001
Week 24	7.74 (5.41)	156 (89.1)	10.59 (5.55)	166 (94.3)	−2.56 (−3.53 to −1.59)	0.51 (0.32-0.70)	<.001
SCI-8
Baseline	12.53 (7.55)	175 (100)	11.99 (7.43)	176 (100)	NA	NA	NA
Week 10	17.33 (8.17)	158 (90.3)	14.25 (7.36)	169 (96.0)	2.67 (1.48 to 3.86)	0.36 (0.20-0.52)	<.001
Week 24	18.76 (8.35)	156 (89.1)	14.83 (7.55)	166 (94.3)	3.44 (2.22 to 4.66)	0.46 (0.30-0.62)	<.001
CGI-S
Baseline	4.83 (0.59)	175 (100)	4.82 (0.61)	176 (100)	NA	NA	NA
Week 10	3.32 (1.02)	145 (82.9)	4.02 (0.85)	156 (88.6)	−0.69 (−0.90 to −0.49)	1.16 (0.82-1.50)	<.001
Week 24	3.03 (1.18)	148 (84.6)	3.80 (0.98)	150 (85.2)	−0.77 (−0.99 to −0.56)	1.30 (0.93-1.65)	<.001

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Abbreviations: AMD, adjusted mean difference; CGI-S, Clinical Global Impression–Severity scale; DCBT, digital cognitive behavioral therapy; GAD-7, 7-item Generalized Anxiety Disorder scale; NA, not applicable; PHQ-8, Patient Health Questionnaire–8; SCI, 8-item Sleep Condition Indicator.

^{^a}

Primary outcome.

Secondary Outcomes

A significant treatment advantage was evident at week 10 for participants who had received DCBT relative to the psychoeducation arm for all secondary outcomes, including depression (PHQ-8: AMD, −2.40 [95% CI, −3.36 to −1.43] points; P < .001; Cohen d, 0.48 [95% CI, 0.29-0.67]), sleep difficulty (SCI-8: AMD, 2.67 [95% CI, 1.48-3.86] points; P < .001; Cohen d, 0.36 [95% CI, 0.20-0.52]), and rater evaluated GAD severity (CGI-S: AMD, −0.69 [95% CI, −0.90 to −0.49] points; P < .001; Cohen d, 1.16 [95% CI, 0.82-1.50]); all significant differences were maintained at the 24-week follow-up assessment (Table 2).

Safety

There were no clinically meaningful differences in adverse events by arm. Adverse events potentially related to DCBT use were panic attacks (n = 5 [2.9%]), depression symptoms (n = 5 [2.9%]), hormonal or seasonal mood symptoms (n = 3 [1.7%]), suicidal ideation (n = 3 [1.7%]), posttraumatic stress disorder symptoms (n = 1 [0.6%]), musculoskeletal pain (n = 6 [3.4%]), and headache (n = 3 [1.7%]). There were no unanticipated adverse device effects. eTables 2 and 3 in Supplement 2 provide a full summary of adverse events.

Exploratory Analyses

Within the DCBT arm, 152 participants (86.9%) completed 2 or more techniques, 120 (68.8%) completed 4 techniques, and 99 (56.6%) completed 15 or more lessons and practices, with a dose-response relationship for both coprimary outcomes. Effect sizes for GAD-7 outcomes at 10 weeks increased with greater treatment engagement: Cohen d was 1.27 (95% CI, 1.00-1.55) for completing 2 or more techniques, 1.39 (95% CI, 1.11-1.69) for 4 techniques, and 1.48 (95% CI, 1.18-1.80) for 15 or more lessons and practices. Similar associations between treatment engagement and outcome were seen for the CGI-I outcomes (eTables 4 and 5 in Supplement 2). Evaluation of the results in the subsample of individuals taking anxiety medications at baseline revealed significant benefit for DCBT over psychoeducation on both coprimary outcome measures (CGI-I: OR, 19.50 [95% CI, 5.67-67.02]; P < .001; GAD-7: AMD, 3.89 [95% CI, 5.65-2.13] points; P < .001; Cohen d, 1.24 [95% CI, 0.68-1.80]) (eTables 6 and 7 in Supplement 2).

Discussion

This large clinical trial demonstrated that a smartphone-delivered DCBT intervention for adults with GAD was safe and efficacious. Relative to the initial randomized clinical trial of this treatment,¹⁶ the current trial used a more stringent control, included both patient-reported outcomes and outcomes rated by blinded independent evaluators, and examined longer-term outcomes with a final evaluation at 24 weeks postrandomization. Data from the current trial indicate that the control condition, a self-directed, online psychoeducation condition designed to match the intervention on key characteristics, set a strong standard for comparison, with similar rates of intervention access and trial retention across arms and a 34.6% remission rate in the control arm, consistent with the broader literature showing reliable benefits for psychoeducation interventions alone.^17,25 Furthermore, given that self-directed online psychoeducation has documented efficacy,^17,18 is commonly used in clinical practice,³¹ and represents the initial intervention in a stepped care model for GAD,³² the current trial addressed the public health question of whether DCBT can offer superior outcomes compared with a commonly available, alternative intervention.

Relative to psychoeducation, the DCBT intervention showed significantly greater efficacy on both interview-based and self-reported outcomes, surpassing prespecified thresholds for clinical significance. At 10 weeks, 71.0% of DCBT participants experienced remission relative to 34.6% of psychoeducation participants, with these rates persisting through 24 weeks. DCBT also had significant benefit on GAD-7 scores at both 10 and 24 weeks, with large between-group effects (Cohen d values of 1.09 and 0.96, respectively). There is meaningful variability in the effects observed across the literature for DCBT treatments for GAD, reflecting the variability in how DCBT for GAD can be implemented.¹⁵ The DaylightRx DCBT has yielded larger effects than those of other digital interventions,¹⁵ which may reflect more effective treatment elements within this DCBT or a format that drives stronger engagement with treatment. DaylightRx specifically directs patients to implement techniques in their lives, which could reduce risk for overdependency on the app and improve skill acquisition and clinical outcomes. The improvement within the DCBT arm in this trial is consistent with that of a previous trial,¹⁶ with the smaller between-group effect likely reflecting the active psychoeducation control rather than a waiting list control used previously.

Significant advantages for DCBT were also evident in secondary outcomes, including depressive symptoms and sleep disturbance at 10 and 24 weeks. These findings are important given the prevalence of and disability associated with depression and sleep disruption in individuals with GAD^33,34 and the established efficacy of therapist-delivered CBT for GAD in alleviating these concerns.^34,35,36,37

Safety evaluations conducted at 10 and 24 weeks were more rigorous than typical for clinical trials of CBT^38,39,40 and indicated that adverse events were similar in both arms, with most adverse events consistent with those commonly reported in anxiety treatment.³⁰ This favorable safety profile, in combination with the strong engagement observed in this and previous studies,^16,23 indicates that DCBT is both safe and well tolerated.

Strengths and Limitations

Notable strengths of the study are its size, broad inclusion and exclusion criteria, and thorough and proactive safety evaluation. Participants had clear and impairing GAD (score ≥15 on the GAD-7 at screening and diagnosis by structured interview), and efficacy at higher GAD severity is important to provide confidence for clinical referral. Individuals taking stable medication for anxiety were allowed in the trial and represented 24.2% of the sample, further highlighting the generalizability of results to typical clinical populations. The use of a blinded-rater outcome measure is a strength of this study, and the CGI-I is a well-established and widely used measure. Ratings were made based on a standardized rubric, and interrater reliability was controlled though consensus meetings throughout the study; however, interrater reliability data were not directly collected in this trial.

This study also has limitations. Racial diversity of the sample diverged from US Census data⁴¹ by more than 5% lower than expected inclusion of Hispanic and Latino adults (6.3% of the sample) and higher inclusion of White adults (71.8% of the sample), encouraging further study of more diverse populations. We did not examine moderators, including whether treatment response differed by racial and ethnic groups or symptom chronicity. Future investigations should also investigate patient preferences for intervention modality (eg, therapist-delivered, app-based, or written) and how these may impact outcomes. This trial excluded participants with psychosis, bipolar disorder, obsessive-compulsive disorder, moderate or greater risk for suicide, or GAD-7 scores below 15; future studies should examine the generalizability of the findings to these patient groups. In addition, data on time spent with each intervention were not available.

Conclusions

In this randomized clinical trial, DCBT offered significant and sustained benefits to adults with GAD. Given the longstanding limitations on access to empirically supported CBT,^13,14 the validation of an efficacious DCBT program that can be prescribed by mental health and primary care practitioners has the potential for dramatic public health impact, particularly given cost savings estimated for this approach.^42,43 Interventions like DCBT represent a new class of digital mental health treatments, as defined by the Centers for Medicare & Medicaid Services, that are cleared by the US Food and Drug Administration and reimbursable under incident to practitioner service codes.⁴⁴ The consistent evidence for the efficacy of this smartphone-accessible DCBT suggests it is a scalable, first-line treatment option for adults with GAD.

Supplement 1.

Trial Protocol

jamanetwopen-e2548884-s001.pdf^{(1.5MB, pdf)}

Supplement 2.

eTable 1. Worst-Case Plausible Analyses Showing Robustness of CGI-I Results to Missingness

eTable 2. Descriptive Comparison of Adverse Events Between Study Groups

eTable 3. Number of Adverse Events by Type, Time Point, Group, and Severity

eTable 4. Engagement Adjusted Analysis of CGI-I for Participants Who Received DaylightRx

eTable 5. Engagement Adjusted Analysis of GAD-7 for Participants Who Received DaylightRx

eTable 6. CGI-I Primary Analyses in the Subsample of Participants That Were Taking Medication for Anxiety at Baseline (n = 85)

eTable 7. GAD-7 Primary Analyses in the Subsample of Participants That Were Taking Medication for Anxiety at Baseline (n = 85)

jamanetwopen-e2548884-s002.pdf^{(316.3KB, pdf)}

Supplement 3.

Data Sharing Statement

jamanetwopen-e2548884-s003.pdf^{(16KB, pdf)}

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

Supplement 1.

Trial Protocol

jamanetwopen-e2548884-s001.pdf^{(1.5MB, pdf)}

Supplement 2.

eTable 1. Worst-Case Plausible Analyses Showing Robustness of CGI-I Results to Missingness

eTable 2. Descriptive Comparison of Adverse Events Between Study Groups

eTable 3. Number of Adverse Events by Type, Time Point, Group, and Severity

eTable 4. Engagement Adjusted Analysis of CGI-I for Participants Who Received DaylightRx

eTable 5. Engagement Adjusted Analysis of GAD-7 for Participants Who Received DaylightRx

eTable 6. CGI-I Primary Analyses in the Subsample of Participants That Were Taking Medication for Anxiety at Baseline (n = 85)

eTable 7. GAD-7 Primary Analyses in the Subsample of Participants That Were Taking Medication for Anxiety at Baseline (n = 85)

jamanetwopen-e2548884-s002.pdf^{(316.3KB, pdf)}

Supplement 3.

Data Sharing Statement

jamanetwopen-e2548884-s003.pdf^{(16KB, pdf)}

[zoi251313r1] 1.American Psychiatric Association . Diagnostic and Statistical Manual of Mental Disorders. 5th ed. American Psychiatric Association; 2013. [Google Scholar]

[zoi251313r2] 2.Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005;62(6):593-602. doi: 10.1001/archpsyc.62.6.593 [DOI] [PubMed] [Google Scholar]

[zoi251313r3] 3.Barrera TL, Norton PJ. Quality of life impairment in generalized anxiety disorder, social phobia, and panic disorder. J Anxiety Disord. 2009;23(8):1086-1090. doi: 10.1016/j.janxdis.2009.07.011 [DOI] [PMC free article] [PubMed] [Google Scholar]

[zoi251313r4] 4.Bandelow B, Michaelis S. Epidemiology of anxiety disorders in the 21st century. Dialogues Clin Neurosci. 2015;17(3):327-335. doi: 10.31887/DCNS.2015.17.3/bbandelow [DOI] [PMC free article] [PubMed] [Google Scholar]

[zoi251313r5] 5.Henning ER, Turk CL, Mennin DS, Fresco DM, Heimberg RG. Impairment and quality of life in individuals with generalized anxiety disorder. Depress Anxiety. 2007;24(5):342-349. doi: 10.1002/da.20249 [DOI] [PubMed] [Google Scholar]

[zoi251313r6] 6.Revicki DA, Travers K, Wyrwich KW, et al. Humanistic and economic burden of generalized anxiety disorder in North America and Europe. J Affect Disord. 2012;140(2):103-112. doi: 10.1016/j.jad.2011.11.014 [DOI] [PubMed] [Google Scholar]

[zoi251313r7] 7.National Institute for Health and Care Excellence . Generalised anxiety disorder and panic disorder in adults: management. NICE clinical guideline No. 113. Published January 26, 2011. Updated June 15, 2020. Accessed January 23, 2025. https://www.nice.org.uk/guidance/cg113/resources/generalised-anxiety-disorder-and-panic-disorder-in-adults-management-pdf-35109387756997

[zoi251313r8] 8.Locke AB, Kirst N, Shultz CG. Diagnosis and management of generalized anxiety disorder and panic disorder in adults. Am Fam Physician. 2015;91(9):617-624. [PubMed] [Google Scholar]

[zoi251313r9] 9.Carl E, Witcraft SM, Kauffman BY, et al. Psychological and pharmacological treatments for generalized anxiety disorder (GAD): a meta-analysis of randomized controlled trials. Cogn Behav Ther. 2020;49(1):1-21. doi: 10.1080/16506073.2018.1560358 [DOI] [PMC free article] [PubMed] [Google Scholar]

[zoi251313r10] 10.Gersh E, Hallford DJ, Rice SM, et al. Systematic review and meta-analysis of dropout rates in individual psychotherapy for generalized anxiety disorder. J Anxiety Disord. 2017;52:25-33. doi: 10.1016/j.janxdis.2017.10.001 [DOI] [PubMed] [Google Scholar]

[zoi251313r11] 11.van Dis EAM, van Veen SC, Hagenaars MA, et al. Long-term outcomes of cognitive behavioral therapy for anxiety-related disorders: a systematic review and meta-analysis. JAMA Psychiatry. 2020;77(3):265-273. doi: 10.1001/jamapsychiatry.2019.3986 [DOI] [PMC free article] [PubMed] [Google Scholar]

[zoi251313r12] 12.Heuzenroeder L, Donnelly M, Haby MM, et al. Cost-effectiveness of psychological and pharmacological interventions for generalized anxiety disorder and panic disorder. Aust N Z J Psychiatry. 2004;38(8):602-612. doi: 10.1080/j.1440-1614.2004.01423.x [DOI] [PubMed] [Google Scholar]

[zoi251313r13] 13.Wolitzky-Taylor K, Fenwick K, Lengnick-Hall R, et al. A preliminary exploration of the barriers to delivering (and receiving) exposure-based cognitive behavioral therapy for anxiety disorders in adult community mental health settings. Community Ment Health J. 2018;54(7):899-911. doi: 10.1007/s10597-018-0252-x [DOI] [PMC free article] [PubMed] [Google Scholar]

[zoi251313r14] 14.Gunter RW, Whittal ML. Dissemination of cognitive-behavioral treatments for anxiety disorders: overcoming barriers and improving patient access. Clin Psychol Rev. 2010;30(2):194-202. doi: 10.1016/j.cpr.2009.11.001 [DOI] [PubMed] [Google Scholar]

[zoi251313r15] 15.Linardon J, Cuijpers P, Carlbring P, Messer M, Fuller-Tyszkiewicz M. The efficacy of app-supported smartphone interventions for mental health problems: a meta-analysis of randomized controlled trials. World Psychiatry. 2019;18(3):325-336. doi: 10.1002/wps.20673 [DOI] [PMC free article] [PubMed] [Google Scholar]

[zoi251313r16] 16.Carl JR, Miller CB, Henry AL, et al. Efficacy of digital cognitive behavioral therapy for moderate-to-severe symptoms of generalized anxiety disorder: a randomized controlled trial. Depress Anxiety. 2020;37(12):1168-1178. doi: 10.1002/da.23079 [DOI] [PubMed] [Google Scholar]

[zoi251313r17] 17.Smits JA, Hofmann SG. A meta-analytic review of the effects of psychotherapy control conditions for anxiety disorders. Psychol Med. 2009;39(2):229-239. doi: 10.1017/S0033291708003498 [DOI] [PubMed] [Google Scholar]

[zoi251313r18] 18.Donker T, Griffiths KM, Cuijpers P, Christensen H. Psychoeducation for depression, anxiety and psychological distress: a meta-analysis. BMC Med. 2009;7(1):79. doi: 10.1186/1741-7015-7-79 [DOI] [PMC free article] [PubMed] [Google Scholar]

[zoi251313r19] 19.Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother. 2010;1(2):100-107. doi: 10.4103/0976-500X.72352 [DOI] [PMC free article] [PubMed] [Google Scholar]

[zoi251313r20] 20.Sheehan DV, Lecrubier Y, Sheehan KH, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59(suppl 20):22-33. [PubMed] [Google Scholar]

[zoi251313r21] 21.Spitzer RL, Kroenke K, Williams JBW, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092-1097. doi: 10.1001/archinte.166.10.1092 [DOI] [PubMed] [Google Scholar]

[zoi251313r22] 22.US Food and Drug Administration . Pediatric medical devices. Accessed November 10, 2025. https://www.fda.gov/medical-devices/products-and-medical-procedures/pediatric-medical-devices

[zoi251313r23] 23.Miller CB, Gu J, Henry AL, et al. Feasibility and efficacy of a digital CBT intervention for symptoms of generalized anxiety disorder: a randomized multiple-baseline study. J Behav Ther Exp Psychiatry. 2021;70:101609. Published online September 8, 2020. doi: 10.1016/j.jbtep.2020.101609 [DOI] [PubMed] [Google Scholar]

[zoi251313r24] 24.Big Health . Daylight Rx: the first FDA-cleared, reimbursable anxiety treatment. Accessed November 10, 2025. https://www.bighealth.com/daylight-rx

[zoi251313r25] 25.Dear BF, Titov N, Sunderland M, et al. Psychometric comparison of the Generalized Anxiety Disorder Scale-7 and the Penn State Worry Questionnaire for measuring response during treatment of generalised anxiety disorder. Cogn Behav Ther. 2011;40(3):216-227. doi: 10.1080/16506073.2011.582138 [DOI] [PubMed] [Google Scholar]

[zoi251313r26] 26.Berk M, Ng F, Dodd S, et al. The validity of the CGI severity and improvement scales as measures of clinical effectiveness suitable for routine clinical use. J Eval Clin Pract. 2008;14(6):979-983. doi: 10.1111/j.1365-2753.2007.00921.x [DOI] [PubMed] [Google Scholar]

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PERMALINK

Digital Cognitive Behavioral Treatment for Generalized Anxiety Disorder

E Marie Parsons, PhD

Tali Ball, PhD

Jenna Carl, PhD

Alasdair L Henry, PhD

Richard Emsley, PhD

Christopher B Miller, PhD

Eileen Y Wong, BA

Emily Coombs, BA

Daniel Collins, BA

Laura J Long, PhD

Anca Chis Ster, PhD

Jasper A J Smits, PhD

Michael W Otto, PhD

Key Points

Question

Findings

Meaning

Abstract

Importance

Objective

Design, Setting, and Participants

Intervention

Main Outcomes and Measures

Results

Conclusions and Relevance

Trial Registration

Introduction

Methods

Design

Participants

Procedures

Randomization and Masking

Measures

Statistical Analysis

Results

Table 1. Baseline Participant Characteristics.

Figure 1. CONSORT Diagram of Participant Flow.

Primary Outcomes

Figure 2. Remission Rate Through 24 Weeks Postrandomization.

Figure 3. Anxiety Severity From Baseline Through 24 Weeks Postrandomization, Based on 7-Item Generalized Anxiety Disorder (GAD-7) Scale Scores.

Table 2. Primary and Secondary Continuous Outcomes Through 24 Weeks Postrandomization.

Secondary Outcomes

Safety

Exploratory Analyses

Discussion

Strengths and Limitations

Conclusions

References

Associated Data

Supplementary Materials

ACTIONS

PERMALINK

RESOURCES

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