Evaluation of an online-based self-help intervention for patients with panic disorder – Study protocol for a randomized controlled trial

BACKGROUND: Panic disorder is a debilitating mental disorder that can lead to functional impairments, low quality of life, and increased risk of developing comorbid mental disorders. There is now evidence for the efficacy of both guided and unguided online interventions for panic disorders. To establish the usefulness of such interventions with high ecological validity, we want to evaluate the efficacy of an online self-help program for panic disorder with and without comorbid agoraphobia. METHODS/DESIGN: Patients (N = 156) diagnosed with panic disorder with or without comorbid agoraphobia between 18 and 65 years with internet access, and sufficient German language skills will be recruited for this study. The intervention group (IG; N = 78) will receive access to the 12-week self-help online program Selfapy. The waitlist control group (CG; N = 78) will receive no intervention in the context of the study. Both groups will be allowed to access further health care services (e.g., inpatient treatment), reflecting current routine care in Germany. Outcome measures will be assessed at baseline (T1), 6 weeks (T2), and 12 weeks (T3) after the start of the intervention. The primary outcomes will be panic symptoms and quality of life at T3. Secondary outcomes include depression, work capacity, therapy-related expenses and burdens, health literacy, and side effects. We expect substantial improvements in the intervention group. We aim to evaluate the therapeutic effects and the cost-efficacy of Selfapy and its benefits for the German healthcare system. DISCUSSION: Online interventions may proof to be a cost-effective supplement to the healthcare system that can substantially reduce waiting periods for treatment. Trial registration drks.de Identifier: DRKS00023800 (registered on 06th July 2021) https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023800