QUATEMAR: a guided mental health app with tele-coaching to bridge the waiting time for starting outpatient psychotherapy - Study protocol for a three-arm randomized controlled trial

Abstract Background Although 75% of German patients attending a psychotherapeutic consultation are deemed in need of psychotherapy, approximately 50% face waiting times of 5 months on average, increasing the risk for mental health deterioration and deterrence from further help-seeking. A promising approach to bridge this gap lies in guided apps that assist in searching for a psychotherapist and provide psychological competencies during the waiting period. This study evaluates whether an app-based intervention with tele-coaching by licensed psychotherapists reduces the psychopathological symptom severity compared with a control group. Methods In a three-arm randomized controlled trial, 360 participants will be randomized 1:1:1 to an app with 6 or 12 weekly tele-coaching sessions, or a psychoeducational control website. Inclusion criteria encompass adults with access to an app-enabled device who had received an indication for outpatient psychotherapy with a waiting period longer than 4 weeks. Exclusion criteria comprise acute danger of self-harm or harm to others, acute psychotic symptoms, and linguistic or neurocognitive barriers. Data will be collected at baseline, 12 and 24 weeks through telephone interviews, and online questionnaires. The primary outcome, psychopathological symptom severity, will be assessed via interview via the AMDP system. Discussion The results of this study will contribute to the evaluation of guided digital healthcare before the start of outpatient psychological treatment. If the guided app-based intervention is found to be (cost-)effective, it could significantly contribute to bridging the healthcare gap for individuals waiting for outpatient psychotherapy and serve as an integrated support program in routine care. Trial Registration The trial protocol is prospectively registered with DRKS under protocol registration number DRKS00033588. Date of registration: September 25, 2024. Recruitment is ongoing.