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

BACKGROUND: Informed consent is an ethical prerequisite for psychotherapy. There are no routinely used standardized strategies for obtaining informed consent. A new optimized informed consent consultation (OIC) strengthened treatment-relevant aspects. It remains unclear which factors influence the OIC efficacy regarding clinical and decision-related outcomes. METHODS: N = 122 adults were included in a randomized controlled online trial. Participants received an information brochure on psychotherapy (TAU; n = 61) or OIC + TAU (n = 61). The main and interaction effects of group allocation, therapeutic alliance, prior knowledge about psychotherapy and treatment motivation on treatment expectations, decisional conflict and capacity to consent were tested. Floodlight analyses were conducted for significant interactions. RESULTS: Large interaction effects were shown between treatment motivation and group allocation on treatment expectations (ß = -0.53) and between prior knowledge and group assignment on capacity to consent (ß = 0.68). The interaction between treatment motivation and group allocation was significant up to a motivation score of 5.54 (range: 1-7). The interaction between prior knowledge and group assignment was significant up to a knowledge score of 14.38 (range: 5-20). CONCLUSION: Moderator analyses indicated varying efficacy degrees for the OIC regarding decisional outcomes and expectation. Especially patients with little treatment motivation or low prior knowledge benefited from optimized information about the efficacy and possible side effects of psychotherapy. TRIAL REGISTRATION: PsychArchives (https://doi.org/10.23668/psycharchives.4929): 17.06.2021.

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) 2024 APA, all rights reserved).

Capacity to consent to psychotherapy: Reliability of the newly adapted German version of the MacArthur Competence Assessment Tool for Treatment for psychotherapy.

BACKGROUND: Patients' capacity to consent to treatment (CCT) is a prerequisite for ethically sound informed consent in psychotherapy. The MacArthur Competence Assessment Tool for Treatment (MacCAT-T) is a reliable instrument for assessing CCT. A German version was adapted to the psychotherapeutical context (MacCAT-PT) to investigate its reliability and possible influences of age, education and prior experience with psychotherapy on CCT in a mixed clinical sample. METHODS: N = 108 patients with indication for psychotherapy were recruited. The MacCAT-PT was administered by trained psychologists, took 20 min on average and was rated by the administering psychologist and an independent rater. Reliability statistics were investigated and regression analyses were conducted on MacCAT-PT scores and sociodemographic variables. RESULTS: Sufficient to moderate inter-rater reliability (ICC = 0.80) and internal consistency (α = 0.80) were found for the total sum score of the MacCAT-PT and its scales, Understanding (ICC = 0.79, α = 0.77), Reasoning (ICC = 0.57, α = 0.65) and Making a Choice (ICC = 0.57). Appreciation featured an unacceptable inter-rater reliability (ICC = -0.01). Regression analyses indicated no significant effects. CONCLUSION: These findings suggest that the MacCAT-PT is a reliable tool for assessing patients' overall CCT in psychotherapy. Psychometric properties of three scales were of good quality, while Appreciation needs to be reanalysed in patient samples with lower motivation for psychotherapy or limited CCT. The CCT may be suggested to be independent of age, education and prior experience. Future research should provide analyses focusing on structural and clinical validity in multiple clinical samples.

Optimized Informed Consent for Psychotherapy: Protocol for a Randomized Controlled Trial.

BACKGROUND: Informed consent is a legal and ethical prerequisite for psychotherapy. However, in clinical practice, consistent strategies to obtain 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 web-based trial aiming to investigate the efficacy of a one-session optimized informed consent consultation. METHODS: The optimized informed consent consultation was developed to provide information on the setting, efficacy, mechanisms, and negative effects via expectation management and shared decision-making techniques. A total of 122 participants with an indication for psychotherapy will be recruited. Participants will take part in a baseline assessment, including a structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders-fifth edition (DSM-5) disorders. Eligible participants will be randomly assigned either to a control group receiving an information brochure about psychotherapy as treatment as usual (n=61) or to an intervention group receiving treatment as usual and the optimized informed consent consultation (n=61). Potential treatment effects will be measured after the treatment via interview and patient self-report and at 2 weeks and 3 months follow-up via web-based 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. RESULTS: This trial received a positive ethics vote by the local ethics committee of the Center for Psychosocial Medicine, University-Medical Center Hamburg-Eppendorf, Hamburg, Germany on April 1, 2021, and was prospectively registered on June 17, 2021. The first participant was enrolled in the study on August 5, 2021. We expect to complete data collection in December 2022. After data analysis within the first quarter of 2023, the results will be submitted for publication in peer-reviewed journals in summer 2023. CONCLUSIONS: If effective, the optimized informed consent consultation might not only constitute an innovative clinical tool to meet the ethical and legal obligations of informed consent but also strengthen the contributing factors of psychotherapy outcome, while minimizing nocebo effects and fostering shared decision-making. TRIAL REGISTRATION: PsychArchives; http://dx.doi.org/10.23668/psycharchives.4929. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39843.