Department of Clinical Psychology, VU University and Amsterdam Public Health Research, Amsterdam, The Netherlands.
Department of Psychosis, Parnassia Psychiatric Institute, The Hague, The Netherlands.
Trials. 2023 Oct 5;24(1):644. doi: 10.1186/s13063-023-07661-x.
Persecutory delusions are strong threat beliefs about others' negative intentions. They can have a major impact on patients' day-to-day life. The Feeling Safe Programme is a new translational cognitive-behaviour therapy that helps patients modify threat beliefs and relearn safety by targeting key psychological causal factors. A different intervention approach, with growing international interest, is peer counselling to facilitate personal recovery. Combining these two approaches is a potential avenue to maximize patient outcomes. This combination of two different treatments will be tested as the Feeling Safe-NL Programme, which aims to promote psychological wellbeing. We will test whether Feeling Safe-NL is more effective and more cost-effective in improving mental wellbeing and reducing persecutory delusions than the current guideline intervention of formulation-based CBT for psychosis (CBTp).
A single-blind parallel-group randomized controlled trial for 190 out-patients who experience persecutory delusions and low mental wellbeing. Patients will be randomized (1:1) to Feeling Safe-NL (Feeling Safe and peer counselling) or to formulation-based CBTp, both provided over a period of 6 months. Participants in both conditions are offered the possibility to self-monitor their recovery process. Blinded assessments will be conducted at 0, 6 (post-treatment), 12, and 18 months. The primary outcome is mental wellbeing. The overall effect over time (baseline to 18-month follow-up) and the effects at each timepoint will be determined. Secondary outcomes include the severity of the persecutory delusion, general paranoid ideation, patient-chosen therapy outcomes, and activity. Service use data and quality of life data will be collected for the health-economic evaluation.
The Feeling Safe-NL Trial is the first to evaluate a treatment for people with persecutory delusions, while using mental wellbeing as the primary outcome. It will also provide the first evaluation of the combination of a peer counselling intervention and a CBT-based program for recovery from persecutory delusions.
Current Controlled Trials ISRCTN25766661 (retrospectively registered 7 July 2022).
被害妄想是指对他人的负面意图存在强烈的威胁信念。它们会对患者的日常生活产生重大影响。“安全感觉计划”是一种新的转化认知行为疗法，通过针对关键心理因果因素，帮助患者改变威胁信念并重新学习安全。一种不同的干预方法，即同伴咨询，越来越受到国际关注，可帮助促进个人康复。将这两种方法结合起来是最大限度提高患者治疗效果的一种潜在途径。这种将两种不同的治疗方法结合起来的方法将作为“安全感觉-NL 计划”进行测试，该计划旨在促进心理健康。我们将测试“安全感觉-NL”在改善心理健康和减少被害妄想方面是否比目前基于精神分裂症认知行为治疗（CBTp）的指导干预更有效和更具成本效益。
这是一项针对 190 名经历被害妄想和低心理健康的门诊患者的单盲平行组随机对照试验。患者将以 1:1 的比例随机分为“安全感觉-NL 组（安全感觉和同伴咨询）”或基于精神分裂症认知行为治疗的指导干预组，两组均在 6 个月内进行治疗。两种治疗条件的参与者都有机会自我监测康复过程。在 0、6（治疗后）、12 和 18 个月时进行盲法评估。主要结局是心理健康。将确定随着时间的推移（从基线到 18 个月随访）的总体效果和每个时间点的效果。次要结局包括被害妄想的严重程度、一般偏执观念、患者选择的治疗结局和活动。将收集服务使用数据和生活质量数据以进行健康经济学评估。
“安全感觉-NL 试验”是首个评估针对被害妄想患者的治疗方法的试验，同时将心理健康作为主要结局。它还将首次评估同伴咨询干预与基于 CBT 的康复计划相结合治疗被害妄想的效果。
当前对照试验 ISRCTN25766661（2022 年 7 月 7 日回顾性注册）。
