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).

中文翻译：

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通过心理治疗的知情同意优化治疗预期和决策：一项随机对照试验。


目的 本研究的目的是确定优化知情同意 (OIC) 咨询心理治疗的有效性和安全性。方法 我们进行了一项随机对照优效性在线试验，包括 2 周的治疗和 3 个月的随访。对 122 名经结构化访谈证实患有精神障碍的成年人（平均年龄：32 岁，性别认同：51.6% 女性，1.6% 不同性别）进行随机分组。参与者收到了一份关于自学心理治疗的信息手册（照常治疗 [TAU]；n = 61）或 TAU 加上单次 OIC，利用期望管理、情境化、框架和共同决策（n = 61）。主要结局是两周随访时的治疗预期。结果 在 2 周随访中，与仅接受 TAU 的参与者相比，接受 OIC 的参与者表现出更积极的治疗期望（平均差异：0.70，95% CI [0.36，1.04]），效果中等（d = 0.73）。同样，OIC 对动机（d = 0.74）和遵守意图（d = 0.46）产生积极影响。 OIC 对减少决策冲突（d = 0.91）和增加知识（d = 0.93）产生了巨大影响。与 TAU 相比，接受 OIC 的参与者表现出更高的同意治疗能力 (d = 0.63) 和对收到的信息的更高满意度 (d = 1.34)。心理治疗的预期不良反应没有产生统计学上显着的组间差异。结果维持在 3 个月的随访中。 n = 10 例 (8.2%) 的数据集缺失（评估后 n = 4、2 周 n = 6、3 个月随访 n = 8）。 结论 通过简短的咨询向患者解释心理治疗如何发挥作用，可以有效地以无害的方式增强治疗期望和决策。需要进一步的试验来澄清这是否能有效转化为更好的治疗结果。 （PsycInfo 数据库记录 (c) 2024 APA，保留所有权利）。