Reducing distress and improving social functioning in daily life in people with auditory verbal hallucinations: Study protocol for the Temstem' randomised controlled trial: Study protocol for the Temstem' randomised controlled trial

Introduction Auditory verbal hallucinations (AVH) are prevalent experiences that can induce distress and impede social functioning. While most voice hearers benefit from antipsychotic medication or cognitive-behavioural therapy, additional effective interventions are needed to reduce the burden of experiencing AVH. Temstem' is an easily accessible and useable smartphone application that was developed by designers in close cooperation with voice hearers and experts. By using language games, Temstem aims to reduce distress and improve social functioning. Methods This is a single-blind multicentre randomised controlled trial with two arms: Temstem+AVH monitoring' versus AVH monitoring' (total n=100). Participants are adult patients who suffer daily from AVH and will be recruited in outpatient units. Primary assessment in daily life is made by the Experience Sampling Method (ESM) and daily monitoring with the PsyMate app. During an ESM period of 6 days, participants assess their mental state (including AVH and context) several times a day by filling in short questionnaires. There are three 6-day ESM periods: at baseline (week 0-1), post-treatment (weeks 5-6) and follow-up (weeks 9-10). In addition, during the entire 10-week study period, all participants monitor their AVH two times a day with a short assessment via the PsyMate app. Participants in the Temstem+AVH monitoring condition are provided with the Temstem app from week 1 to 6. Other assessments made at baseline, post-treatment and follow-up are based on questionnaires and a clinical interview. Ethics and dissemination The results from this study will provide an evaluation of the effectiveness of Temstem, a non-invasive and easily accessible app for voice hearers, and insight into the determinants of optimal use. Results will be disseminated unreservedly, irrespective of the magnitude or direction of the effects. This study protocol was approved by the Medical Ethics Committee of the VU University Medical Centre (METC number: 2015.435/NL53684.029.15). Trial registration number ISRCTN75717636; Pre-results.