Department of Psychiatry, Leiden University Medical Center (LUMC), Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
Trials. 2021 Oct 23;22(1):731. doi: 10.1186/s13063-021-05666-y.
After regular treatment, patients with persistent depressive disorder (PDD) may remain in specialized psychiatric outpatient care without achieving remission. Lacking other options, these patients often receive long-term, non-protocolized care as usual (CAU) that does not involve the partner/caregiver of the patient. Although the revised depression treatment guidelines suggest focusing on psychiatric rehabilitation and self-management as the next treatment step for PDD, an evidence-based cost-effective self-management protocol for PDD is lacking. This study investigates the "Patient and Partner Education Program for All Chronic Illnesses" (PPEP4All) as a brief self-management protocol that could lead to lower costs, higher quality of life, and less disease burden in PDD patients and their partners/caregivers.
Presented is the rationale and methods of a multicenter pragmatic randomized controlled trial to evaluate the clinical efficacy and cost-effectiveness of PPEP4All for patients with PDD and their partners/caregivers. In accordance with current recommendations, a mixed methods research approach is used with both quantitative and qualitative data. A total of 178 eligible outpatients with PDD and their partners/caregivers are recruited and randomized to either PPEP4All or CAU. Those assigned to PPEP4All receive nine weekly self-management sessions with a trained PPEP4All therapist. Primary and secondary outcome measurements are at 0, 3, 6, and 12 months.
This project will result in the implementation of a self-management intervention for patients with PDD, meeting an urgent need in mental healthcare. Using PPEP4All can optimize the quality and efficiency of care for both patients with PDD and their partners/caregivers.
Netherlands Trial Register Identifier NTR5973 . Registered on 20 July 2016.
经过常规治疗，持续性抑郁障碍（PDD）患者可能仍留在专门的精神科门诊接受治疗，但未达到缓解。由于缺乏其他选择，这些患者通常会接受长期、非规范化的常规护理（CAU），而不涉及患者的伴侣/照顾者。尽管修订后的抑郁治疗指南建议将精神康复和自我管理作为 PDD 的下一步治疗，但缺乏针对 PDD 的基于证据的、具有成本效益的自我管理方案。本研究调查了“所有慢性病患者和其伴侣/照顾者的教育计划”（PPEP4All），作为一种简短的自我管理方案，可能会降低 PDD 患者及其伴侣/照顾者的成本、提高生活质量和减轻疾病负担。
本文介绍了一项多中心实用随机对照试验的基本原理和方法，以评估 PPEP4All 对 PDD 患者及其伴侣/照顾者的临床疗效和成本效益。根据当前的建议，采用混合方法研究方法，包括定量和定性数据。共招募了 178 名符合条件的 PDD 门诊患者及其伴侣/照顾者，并将其随机分为 PPEP4All 组或 CAU 组。接受 PPEP4All 组的患者接受了 9 次每周一次的自我管理课程，由经过培训的 PPEP4All 治疗师授课。主要和次要结局测量在 0、3、6 和 12 个月时进行。
该项目将为 PDD 患者实施自我管理干预措施，满足精神卫生保健的迫切需求。使用 PPEP4All 可以优化 PDD 患者及其伴侣/照顾者的护理质量和效率。
荷兰试验注册标识符 NTR5973。于 2016 年 7 月 20 日注册。
