Doorbreek Dwang Digitaal

Rationale: This study aims to compare personalized exposure and ESM feedback sessions with exposure
as usual in patients with obsessive-compulsive disorder. Personalized exposure will be provided
according to individual needs face-to-face as well as screen-to-screen in ecological valid situation
by means of the app NiceDay. This app will also be used as a data collection tool during therapy.
By means of experience sampling methodology (ESM) objective and subjective data in real-time and
real-place will be systematically collected. Personalized feedback based on ESM data will be used to
identify triggers and protective factors for symptom severity and to optimize the effect of ERP.

Objective: The primary goal of the project is to investigate the effectiveness of providing personalized
mental health care to patients with OCD, compared to exposure and response prevention (ERP) in the
traditional context of a therapist’s room. Evidence based treatment (ERP) will be personalized by using
a smartphone app (NiceDay) as a tool to increase ecological validity of exercises, by conducting them
into patients ‘real time and world'. A second goal is to assess if there is a difference in relapse rates
and patterns between patients receiving personalized ERP compared to ERP as usual. A third goal of
this study is to identify different subgroups of patients on a network level in order to create more insight
in the heterogenic group of OCD patients. With these networks we aim to determine predictors
for treatment success and relapse. A fourth goal is to explore if our treatment approach increases patients’
self-efficacy and active participation in the therapeutic process and to investigate whether this
influences treatment effect. Finally, we are interested in how feasible the use of a smartphone app,
network models and personalized feedback is in perception of both patients and therapists.

Study design: The design of the study will be a 20 sessions (on a weekly basis) 2 group (ERP as
usual versus personalized ERP) randomized controlled clinical trial with repeated measurements at
baseline (T0), 5 weeks of treatment (T1), 10 weeks of treatment (T2), 15 weeks of treatment (T3),
posttest at 20 weeks (T4), 6 weeks follow-up (T5), 3 months follow-up (T6), 6 months follow-up (T7)
and a year follow-up (T8).

Study population: The study will be conducted in 160 patients with an OCD diagnosed according to
DSM 5 criteria.

Intervention (if applicable): One group will receive exposure with response prevention as usual, the
other group will receive personalized exposure with response prevention with smartphone application
NiceDay and personalized feedback sessions based on experience sampling data.

Main study parameters/endpoints: The main study parameter is a difference in treatment outcome
as measured with the Y-BOCS.

We expect to find a difference in treatment effect with a small to medium effect size in favour of the experimental condition

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Exposure as usual
Personalized Exposure