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

Abstract

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.

Informed Consent for Psychotherapy: The Moderating Role of Therapeutic Alliance, Prior Knowledge and Autonomous Motivation on Decision‐Making and Treatment Expectation

“…The present findings on the moderation effects indicate that especially patients with rather little prior knowledge about psychotherapy and/or lower autonomous treatment motivation may benefit the most from an OIC. In such cases, we highly recommend the implementation of an individualized and positively framed OIC in clinical practice to address otherwise often neglected topics such as potential side effects of psychotherapy or treatment alternatives (Dsubanko-Obermayr and Baumann 1998; Gerke, Meyrose, and Nestoriuc 2023), thus likely optimizing treatment outcomes (Beahrs and Gutheil 2001;Gerke, Pauls, et al 2023).…”

“…The TEX-Q has an adequate internal consistency, with Cronbach's α ranging from α = 0.71 to 0.92 for the total score and its subscales (Shedden-Mora et al 2023). Since effects of the OIC on the TEX-Q subscales have also been found by Gerke, Pauls, et al (2023), the subscales treatment benefit (three items), positive impact (three items) and process (two items) were also included in the present analyses in addition to the total score.…”

“…The expectation-maximization (EM) algorithm was used to impute data missing at random. A priori power analyses using a medium effect size based on Gerke, Pauls, et al (2023) indicated that a sample size of N = 103 was required for meaningfully analysing the hypothesized main and interaction effects (β − 1 = 0.80, α = 0.05, f 2 = 0.15, number of predictors = 7).…”

“…Due to its beneficial effects on decisional and treatment outcomes, the OIC is suggested a viable tool for the management of treatment expectation (Gerke, Pauls, et al 2023). Among others, three factors are proposed to be associated with expectation management in this context: therapeutic alliance between the patient and the therapist (Faller and Rudolf 1998;Leuchter et al 2014), patient's prior knowledge about psychotherapy (De Lange, Heilbron, and Kok 2018) and patient's autonomous treatment motivation (Philips and Wennberg 2014).…”

“…When compared to treatment as usual (i.e. generalized information about psychotherapy), a newly developed optimized informed consent consultation (OIC) has been shown to be effective in reducing decisional conflict (patients' conflicts in the decision-making process) and increasing treatment expectation and capacity to consent to psychotherapy (Gerke, Pauls, et al 2023). The OIC is designed to be conducted as a 35-min consultation during psychotherapeutic trial sessions and is supposed to encourage psychotherapists to carefully include information about psychotherapy, allowing patients to develop holistic and adequate treatment expectation.…”