Evaluating a Dual Digital Cognitive Behavioral Therapy and Health and Wellness Coaching Intervention for Anxiety and Depression: Single-Arm Pilot Study.

Background: Anxiety and depressive disorders remain highly prevalent and insufficiently treated, with many individuals experiencing persistent or untreated symptoms, limited access to evidence-based care, or insufficient support between clinical encounters. Adults with disabilities represent a particularly underserved subpopulation, often facing compounded barriers to mental health care and higher rates of anxiety and depression. Digital therapeutics offer a scalable opportunity to address these gaps by extending structured, evidence-based interventions beyond traditional care settings. Objective: This pilot study evaluated Rauha, a novel digital therapeutic created by Toivoa Inc, that integrates cognitive behavioral therapy (CBT)-based modules with live weekly sessions led by a National Board-Certified Health and Wellness Coach (NBC-HWC), delivering structured, smartphone-based psychoeducation and interactive therapeutic exercises combined with personalized mental health coaching to support behavior change. Methods: Thirteen adults with mobility and/or hearing disabilities and clinically elevated anxiety and/or depression were enrolled in a single-arm, within-participants design. Participants completed 8 weeks of CBT modules delivered via smartphone, accompanied by synchronous virtual mental health coaching. Anxiety and depression were assessed using the Hamilton Anxiety and Hamilton Depression Rating Scales, respectively, at baseline, post treatment, and at the 4-week follow-up. Results: Mean reductions were significant for both anxiety (-13.05, SD 2.51; P<.001) and depression (-12.83, SD 1.55; P<.001), exceeding thresholds for clinical significance and sustained through follow-up. Post treatment, 84.6% (11/13) of participants showed clinically significant improvement in both anxiety and depression. At follow-up, 76.9% (10/13) and 92.3% (12/13) of participants showed clinically significant improvement in anxiety and depression, respectively. Between baseline and follow-up time points, these reductions corresponded to mean shifts from moderate to mild anxiety on the Hamilton Anxiety Rating Scale and from moderate to mild/nondepressed on the Hamilton Depression Rating Scale. Participants reported strongly favorable acceptability, experience, and usability ratings for the Rauha treatment program, demonstrating 100% treatment retention and an average replay rate of 5.5 for personalized smartphone content. Conclusions: The findings suggest that a combined digital CBT and NBC-HWC approach can yield clinically meaningful and durable symptom reductions in depression and anxiety, coupled with high user acceptability and engagement, for adults with disabilities. These findings provide preliminary evidence supporting Rauha as a scalable, evidence-informed mental health intervention with the strong potential to improve access and address key barriers to care.