Informed Consent for Psychotherapy: A Randomized Controlled Trial evaluating the Efficacy of an Optimized Informed Consent on Treatment Expectations and Capacity to Consent

Informed consent is a legal and ethical prerequisite for conducting psychotherapy. However, the informed consent for psychotherapy still seems to play a minor role in daily practice. The aim of the present study is to evaluate the efficacy of a newly developed optimized informed consent consultation for psychotherapy (OIC) in a randomized controlled online trial. N=122 adults with indication for psychotherapy will be recruited. After baseline assessment (t0), participants will be randomly assigned either to a control group receiving an information brochure as treatment as usual (TAU) or to the intervention group receiving the OIC in addition to TAU. OIC and post-assessment will take place at the second online study visit (t1; 2 weeks following t0). Two weeks and three months after t1, participants will receive online follow-up questionnaires. Treatment expectation is the primary outcome. Secondary outcomes include capacity to consent, decisional conflicts, autonomous treatment motivation, and adherence intention. This is a preregistration of the article: Gerke, L., Ladwig, S., Pauls, F., Trachsel, M., Härter, M., & Nestoriuc, Y. (2022). Optimized Informed Consent for Psychotherapy: Protocol for a Randomized Controlled Trial. JMIR Research Protocols, 11(9). https://doi.org/10.2196/39843 unknown other