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.

Informed consent for psychotherapy: Ethical illusion or clinical reality? A survey about psychotherapists' attitudes and practices in Germany.

OBJECTIVE: This study aimed to assess clinicians' attitudes and their current clinical practices regarding informed consent for psychotherapy. METHOD: A convenience sample of N = 530 clinicians in Germany (n = 418 licensed psychotherapists and n = 112 postgraduate psychotherapy trainees) took part in an online survey. RESULTS: Most clinicians (84%) reported obtaining informed consent for psychotherapy in their daily routine. However, many psychotherapists felt unsure about satisfactorily fulfilling the legal (63%) and ethical obligations (52%). The two most frequently reported components of information disclosure related to explaining the terms and conditions of psychotherapy (96%) and the psychotherapeutic approach (91%). Providing information about mechanisms of psychotherapy (33%) and the role of expectations (30%) were least practiced. One in five psychotherapists reported not informing clients about potential risks and side effects. A considerable proportion reported concern about inducing anxiety in patients by disclosing information about risks and side effects (52%). CONCLUSIONS: Although obtaining informed consent for psychotherapy seems to be the rule rather than the exception in clinical practice, the quality of its implementation in terms of legal, ethical and clinical demands remains questionable. Training psychotherapists in providing comprehensive informed consent enables informed decision-making and might have a positive influence on treatment expectations and outcomes.

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.

Frequencies and Predictors of Negative Effects in Routine Inpatient and Outpatient Psychotherapy: Two Observational Studies.

Negative effects of psychotherapy (NEP) include side effects, malpractice, and unethical behavior. Its setting-specific frequencies and predictors are mostly unknown. The two presented studies aim to investigate NEP and its predictors systematically across different treatment settings. In study 1, N = 197 patients of a German outpatient center were recruited, on average, 3.76 years after the termination of psychotherapy. In study 2, data from N = 118 patients of two German inpatient clinics were collected at admission (t 0), discharge (t 1), and 9-month follow-up (t 2). All participants evaluated the negative effects of their previous out- or inpatient psychotherapy with the Inventory for the Balanced Assessment of Negative Effects in Psychotherapy and a priori hypothesized predictors. At least one side effect was reported by 37.3% of inpatients (t 2) and 15.2% of outpatients. At least one case of malpractice and unethical behavior was reported by 28.8% of inpatients (t 2) and 7.1% of outpatients. Inpatients reported significantly more side effects (U = 14347, z = 4.70, p < 0.001, r = 0.26) and malpractice and unethical behavior (U = 14168, z = 5.21, p < 0.001, r = 0.29) than outpatients. Rates of severe malpractice in the form of breaking confidentiality and physical and sexual abuse were less than 1% in both settings. Predictors of side effects were prior experience with psychotherapy and current interpersonal difficulties in the outpatient setting and higher motivation for psychotherapy (t 0) in the inpatient setting. Predictors of malpractice and unethical behavior were younger age in the outpatient setting and poor therapeutic alliance, prior negative experience with malpractice and unethical behavior, and higher outcome expectations in the inpatient setting. NEP are common in both, in- and outpatient settings. Inpatients are at higher risk for the NEP than outpatients. To safeguard patients' wellbeing, the systematic assessment and distinction of side effects and malpractice and unethical behavior should gain more attention in research and clinical practice.

Post-stroke depression and functional impairments - A 3-year prospective study.

BACKGROUND: Post-Stroke Depression (PSD) is a severe condition, affecting about 30% of stroke survivors within a five-year period after stroke. Post-stroke functional impairments (FI) and social support are associated with PSD. It is inconclusive, whether one of the factors, post-stroke FI and PSD, shows a stronger predictive value on the respective other over time. The aims of the present study were to 1) investigate the relationship between PSD, FI, and social support of stroke patients in a 3-year prospective design, and 2) address methodological shortcomings of previous studies. METHODS: We investigated 174 stroke survivors and assessed PSD with a structured clinical interview and a dimensional symptom rating scale. We conducted regression analyses and applied the approach of multiple imputations (MI) for missing data due to dropout during follow-up. RESULTS: PSD prevalence was 32.2% in the acute phase after stroke. Individuals with a PSD in this phase revealed a fivefold higher risk for PSD 3 years later. FI in the acute phase did not additionally contribute to the prediction of PSD at follow-up. Compared to individuals without PSD in the acute phase, individuals with PSD had an increased risk for FI at follow-up. Limitations regarding sample characteristics, design, and dropout are discussed. CONCLUSIONS: Results indicate that PSD rather than FI represents a crucial risk factor for negative long-term consequences regarding physical and psychological health after stroke. Post-stroke treatment might be optimized by a routine assessment of PSD and FI after stroke and considering the results for personalized treatment options.