TOPLINE:

A smartphone-delivered digital cognitive-behavioral therapy (DCBT) program was associated with 71% remission at 10 weeks in adults with generalized anxiety disorder (GAD) compared with 35% for psychoeducation in a new study, with benefits persisting up to 24 weeks.

METHODOLOGY:

• A single-blind, parallel-group, decentralized randomized clinical trial conducted between 2023 and 2024 included more than 300 patients with GAD who were 22 years or older at enrollment (mean age, 41 years; 74% women).
• The participants were randomly assigned 1:1 to receive DCBT or psychoeducation.
• The primary outcomes were remission using the Clinical Global Impressions-Improvement (CGI-I) scale and severity of self-reported anxiety symptoms using the 7-item GAD (GAD-7) scale at 10 and 24 weeks.
• Secondary outcomes included depressive symptoms on the 8-item Patient Health Questionnaire, sleep difficulties on the Sleep Condition Indicator, and severity of GAD using the CGI-Severity scale.

TAKEAWAY:

• DCBT was associated with significantly lower GAD-7 scores than psychoeducation at 10 weeks (mean scores, 7.9 vs 11.7, respectively; P < .001) and 24 weeks (mean scores, 7.2 vs 10.7; P < .001).
• Remission rates were substantially higher in the DCBT group at both 10 weeks (odds ratio [OR], 4.6; P < .001) and 24 weeks (OR, 3.2; P < .001).
• Depressive symptoms (adjusted mean difference [AMD] in scores, -2.4; P < .001), sleep difficulties (AMD, 2.7; P < .001), and severity of GAD (AMD, -0.7; P < .001) were significantly reduced at 10 weeks with DCBT, with benefits persisting at 24 weeks.
• Adverse events were not significantly different between the groups. A treatment-engagement analysis showed a dose-response relationship for both primary outcomes, with participants who completed at least 15 lessons and practices experiencing the strongest effects for GAD-7 outcomes.

IN PRACTICE:

“Given the longstanding limitations on access to empirically supported CBT [cognitive-behavioral therapy], 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,” the investigators wrote.

“The consistent evidence for the efficacy of this smartphone-accessible DCBT suggests it is a scalable, first-line treatment option for adults with GAD,” they added.

SOURCE:

This study was led by E. Marie Parsons, PhD, Boston University, Boston. It was published online on December 15 in JAMA Network Open.

LIMITATIONS:

The racial diversity of the study sample diverged from US Census data, with a lower inclusion of Hispanic and Latino adults and a higher inclusion of White adults. The study excluded participants with psychosis, bipolar disorder, obsessive-compulsive disorder, a moderate or greater suicide risk, or GAD-7 scores below 15, limiting the generalizability of the findings. Additionally, data on time spent with each intervention were not available, and interrater reliability data for the CGI-I scale were not directly collected in the trial.

DISCLOSURES:

This study was funded by Big Health Inc. Some investigators reported having financial or other ties with various organizations, including Big Health Inc. Full details are provided in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.