Leonie Gerke, Franz Pauls, Sönke Ladwig, Sarah Liebherz, Klaus Michael Reininger, Levente Kriston, Manuel Trachsel, Martin Härter, Yvonne Nestoriuc
{"title":"Optimizing treatment expectations and decision making through informed consent for psychotherapy: A randomized controlled trial.","authors":"Leonie Gerke, Franz Pauls, Sönke Ladwig, Sarah Liebherz, Klaus Michael Reininger, Levente Kriston, Manuel Trachsel, Martin Härter, Yvonne Nestoriuc","doi":"10.1037/ccp0000851","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>The objective of this research was to determine the efficacy and safety of an optimized informed consent (OIC) consultation for psychotherapy.</p><p><strong>Method: </strong>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]; <i>n</i> = 61) or TAU plus a one-session OIC utilizing expectation management, contextualization, framing, and shared decision making (<i>n</i> = 61). The primary outcome was treatment expectations at 2-week follow-up.</p><p><strong>Results: </strong>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 (<i>d</i> = 0.73). Likewise, OIC positively influenced motivation (<i>d</i> = 0.74) and adherence intention (<i>d</i> = 0.46). OIC entailed large effects on reduction of decisional conflict (<i>d</i> = 0.91) and increase of knowledge (<i>d</i> = 0.93). Participants receiving OIC showed higher capacity to consent to treatment (<i>d</i> = 0.63) and higher satisfaction with received information (<i>d</i> = 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 <i>n</i> = 10 cases (8.2%) were missing (postassessment <i>n</i> = 4, 2-week <i>n</i> = 6, 3-month follow-up <i>n</i> = 8).</p><p><strong>Conclusions: </strong>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).</p>","PeriodicalId":15447,"journal":{"name":"Journal of consulting and clinical psychology","volume":null,"pages":null},"PeriodicalIF":4.5000,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of consulting and clinical psychology","FirstCategoryId":"102","ListUrlMain":"https://doi.org/10.1037/ccp0000851","RegionNum":1,"RegionCategory":"心理学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/11/16 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"PSYCHOLOGY, CLINICAL","Score":null,"Total":0}
引用次数: 0
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. (PsycInfo Database Record (c) 2024 APA, all rights reserved).
期刊介绍:
The Journal of Consulting and Clinical Psychology® (JCCP) publishes original contributions on the following topics: the development, validity, and use of techniques of diagnosis and treatment of disordered behaviorstudies of a variety of populations that have clinical interest, including but not limited to medical patients, ethnic minorities, persons with serious mental illness, and community samplesstudies that have a cross-cultural or demographic focus and are of interest for treating behavior disordersstudies of personality and of its assessment and development where these have a clear bearing on problems of clinical dysfunction and treatmentstudies of gender, ethnicity, or sexual orientation that have a clear bearing on diagnosis, assessment, and treatmentstudies of psychosocial aspects of health behaviors. Studies that focus on populations that fall anywhere within the lifespan are considered. JCCP welcomes submissions on treatment and prevention in all areas of clinical and clinical–health psychology and especially on topics that appeal to a broad clinical–scientist and practitioner audience. JCCP encourages the submission of theory–based interventions, studies that investigate mechanisms of change, and studies of the effectiveness of treatments in real-world settings. JCCP recommends that authors of clinical trials pre-register their studies with an appropriate clinical trial registry (e.g., ClinicalTrials.gov, ClinicalTrialsRegister.eu) though both registered and unregistered trials will continue to be considered at this time.