Advancing CBT for panic disorder and agoraphobia by integrating a digital intervention into treatment: A pilot randomized controlled trial (Preprint)

BACKGROUND Panic disorder and agoraphobia are frequently co-occurring mental disorders affecting millions of people worldwide. Cognitive behavioral therapy (CBT) is the first-line treatment, supported by a wealth of controlled clinical trials. Supportive digital technologies may further enhance its effectiveness. OBJECTIVE This pilot randomized controlled trial investigated if patients with panic disorder and/or agoraphobia benefit from blended cognitive behavioral therapy (bCBT), in which standard CBT is combined with an integrated digital application. METHODS Participants were randomized into two groups after being diagnosed with panic disorder and/or agoraphobia. The bCBT group received standard CBT along with a digital application (elona therapy) used between sessions (n = 34). The control group received standard CBT treatment alone (n = 22) for 12 weeks. Both groups completed assessments including standardized questionnaires covering symptoms of anxiety, symptoms of depression, quality of life, work and daily functioning, and mental health literacy at baseline (T0), after 6 weeks (T1), and 12 weeks (T2). RESULTS Improvements in symptoms of anxiety were descriptively larger for the bCBT group than for the CBT group at 6 weeks (d = -.28). Yet, this difference decreased after 12 weeks (d = -.12) and did not reach statistical significance. bCBT was superior to standard CBT in improving symptoms of depression after 12 weeks (d = -.46 p = .028). In other secondary outcomes, improvements were descriptively larger for bCBT than for CBT, but these differences did not reach statistical significance. CONCLUSIONS bCBT supported by elona therapy showed promising results in reducing symptoms of depression in individuals with panic disorder and/or agoraphobia. In contrast, the benefit of the added digital application for reducing symptoms of anxiety did not reach statistical significance. The pattern of results indicated that bCBT might improve outcomes more quickly, until a treatment ceiling is reached. More research using larger randomized controlled trials (RCTs) is needed to consolidate these findings. CLINICALTRIAL ISRCTN16328317