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. What is the public health significance of this article?: Among patients with mental disorders, an optimized informed consent consultation was superior to treatment as usual in promoting adequate treatment expectations, motivation, and capacity to consent to treatment while decreasing decisional conflict. Results support the efficacy and safety of an optimized informed consent using expectation management, contextualization, framing, and shared decision making among patients with mental disorders. The 35-min informed consent consultation can be easily implemented within trial sessions for a psychotherapy. This study highlights the clinical relevance of explaining to patients how psychotherapy works. [ABSTRACT FROM AUTHOR]