Effectiveness, efficacy, and feasibility of a therapist-aided app for Exposure and Response Prevention: A Parallel-group, Pilot Randomised Control Trial

It is pilot, parallel-group randomised trial to assess the efficacy, feasibility and acceptability of adding a bilingual Exposure and Response Prevention App to usual standard of care, ie, Exposure and Response Prevention for patients diagnosed with obsessive compulsive disorder (OCD). The rationale for developing the app has been the difficulty patients face in completing homework sessions between sessions, which are essential to promote recovery and decrease symptom severity. The app aims to provide psychoeducative material on OCD and ERP; give personalised reminders to complete HW everyday and track the level of anxiety. 

Patients meeting the inclusion/exclusion criteria would be randomized into one of the two groups. The first group would be TAU/Standard care, wherein a trained clinical psychologist would take ERP sessions once in a week. The second group would get access to the bilingual, therapist- enhanced ERP app, along with weekly ERP sessions by the clinical psychologist. The clinical psychologist would be regularly supervised by SKG.In both the groups, ERP would follow a module-based approach to ensure consistency. To assess treatment fidelity, 20% of the sessions in both the groups would be recorded (while ensuring confidentiality) and reviewed by either SKG or KSD and rated on a Likert scale of 0 (not matching the module) to 10 (complete fit to the module). Both groups would go through baseline assessments that would include socio-demographic and clinical profile, CGI, and Y-BOCS. After every session, the therapist would fill the Patient EX/RP Adherence Scale (PEAS). Y-BOCS would be administered again at the end of the 4th session. The assessment at the end-of-intervention would be conducted by a Clinical Psychologist/Psychiatrist blinded to the randomization.

Participant dropouts will be managed by implementing a reminder system. In the event that a participant misses a session, a reminder will be issued via phone call. If a participant misses only one session, their latest recorded data will be carried forward, allowing them to remain enrolled in the study. However, if a participant misses two or more sessions, they will be classified as dropout from the study. This approach aims to maintain participant engagement and data continuity by accommodating occasional absences while ensuring that consistent participation is upheld for the integrity of the study results.

Adequate measures would be taken for data safety.