Optimizing treatment expectations and decision making through informed consent for psychotherapy: A randomized controlled trial.

OBJECTIVE: The objective of this research was to determine the efficacy and safety of an optimized informed consent (OIC) consultation for psychotherapy.

METHOD: We performed a randomized controlled superiority online trial involving 2 weeks of treatment and 3 months of follow-up. One hundred twenty-two adults with mental disorders confirmed by structured interview currently neither in out- nor inpatient psychotherapy (mean age: 32, gender identity: 51.6% female, 1.6% diverse), were randomized. Participants received an information brochure about psychotherapy for self-study (treatment as usual [TAU]; n = 61) or TAU plus a one-session OIC utilizing expectation management, contextualization, framing, and shared decision making ( n = 61). The primary outcome was treatment expectations at 2-week follow-up.

RESULTS: At 2-week follow-up, participants receiving OIC showed more positive treatment expectations compared to those receiving TAU only (mean difference: 0.70, 95% CI [0.36, 1.04]) with a medium effect size ( d = 0.73). Likewise, OIC positively influenced motivation ( d = 0.74) and adherence intention ( d = 0.46). OIC entailed large effects on reduction of decisional conflict ( d = 0.91) and increase of knowledge ( d = 0.93). Participants receiving OIC showed higher capacity to consent to treatment ( d = 0.63) and higher satisfaction with received information ( d = 1.34) compared to TAU. No statistically significant group differences resulted for expected adverse effects of psychotherapy. Results were maintained at 3-month follow-up. Data sets for n = 10 cases (8.2%) were missing (postassessment n = 4, 2-week n = 6, 3-month follow-up n = 8).

CONCLUSIONS: Explaining to patients how psychotherapy works via a short consultation was effective in strengthening treatment expectations and decision making in a nonharmful way. Further trials clarifying whether this effectively translates to better treatment outcomes are required. (PsycInfo Database Record (c) 2023 APA, all rights reserved).