In a randomized clinical trial of adults with generalized anxiety disorder (GAD), a smartphone-delivered digital cognitive behavioral therapy (DCBT) program produced greater improvements that were sustained through 24 weeks than an active psychoeducation control.
The fully remote trial enrolled 351 adults with interview-confirmed GAD and severe baseline symptoms, defined by a score of 15 or higher on the 7-item Generalized Anxiety Disorder scale (GAD-7). Participants were randomized 1:1 to receive either a self-directed, smartphone-based DCBT program or an online psychoeducation intervention designed to match the digital format and self-guided structure of the treatment arm. Outcomes were assessed at 10 weeks, the primary endpoint, and again at 24 weeks.
At the primary endpoint, participants assigned to DCBT showed significantly greater improvements on both coprimary outcomes: clinician-rated remission and self-reported anxiety severity. Remission, defined as a score of 2 or lower on the Clinical Global Impressions–Improvement scale, was achieved by 71.0% of participants in the DCBT group compared with 34.6% in the psychoeducation group. Improvements were sustained at 24 weeks, with remission rates of 77.7% and 52.0%, respectively.
Self-reported anxiety symptoms followed a similar pattern. Mean GAD-7 scores were significantly lower in the DCBT group at all postbaseline time points, with benefits sustained through 24 weeks. Participants receiving DCBT also showed greater improvements in secondary outcomes, including depressive symptoms, sleep quality, and clinician-rated anxiety severity, with benefits maintained through follow-up.
The trial incorporated several design features intended to strengthen interpretability, including blinded independent evaluators, a credible active control condition, and high retention across both arms. Adverse events were infrequent and similar between groups, with no unanticipated safety concerns reported.
The authors suggest the findings are relevant to ongoing challenges in accessing evidence-based CBT for GAD, including limited therapist availability and treatment burden. While the intervention was self-directed, engagement analyses suggested a dose–response relationship, with greater symptom improvement observed among participants who completed more lessons and techniques.
The authors suggest that an effective, smartphone-delivered CBT program could expand access to first-line treatment for GAD—particularly in settings where traditional therapy is difficult to obtain. They add that the results support the use of DCBT as a scalable treatment option within stepped-care or adjunctive care models, rather than as a replacement for clinician-delivered therapy.
Source: JAMA Network Open
