Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 25, 2022
Date Accepted: Jun 28, 2022
Optimized informed consent for psychotherapy: a study protocol for a randomized controlled trial
ABSTRACT
Background:
Informed consent is a legal and ethical prerequisite for psychotherapy. However, in clinical practice, consistent strategies to conduct informed consent are scarce. Inconsistencies exist regarding the overall validity of informed consent for psychotherapy as well as the disclosure of potential mechanisms and negative effects; the latter posing a moral dilemma between patient autonomy and nonmaleficence.
Objective:
This protocol describes a randomized controlled online trial aiming to investigate the efficacy of a one-session optimized informed consent consultation (OIC).
Methods:
The OIC was developed to provide information on setting, efficacy, mechanisms, and negative effects via expectation management and shared decision-making techniques. A total of N=122 participants with an indication for psychotherapy will be recruited. Participants will take part in a baseline assessment including a Structured Clinical Interview for DSM-5 disorders. Eligible participants will be randomly assigned either to a control group receiving an information brochure about psychotherapy as treatment as usual (TAU; n=61) or to an intervention group receiving TAU and the OIC (n=61).
Results:
Treatment effects will be measured post-treatment via interview and patient self-report, and at two weeks and 3 months follow-up via online questionnaires. Treatment expectation is the primary outcome. Secondary outcomes include the capacity to consent, decisional conflict, autonomous treatment motivation, adherence intention, and side-effect expectations. Recruitment began in 2021 and is ongoing.
Conclusions:
If effective, the OIC might not only constitute an innovative clinical tool to meet the ethical and legal obligation of informed consent but might also strengthen contributing factors of psychotherapy outcome, while minimizing nocebo effects and fostering shared decision-making. Clinical Trial: Prospectively registered on 17th June 2021 in PsychArchives, an independent repository for psychological science (http://dx.doi.org/10.23668/psycharchives.4929).
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