Department of Nursing and Physiotherapy, University of the Balearic Islands (UIB), Palma, Spain.
Research Group On Global Health, University of the Balearic Islands (UIB), Palma, Spain.
BMC Psychiatry. 2024 Sep 30;24(1):639. doi: 10.1186/s12888-024-06094-3.
BACKGROUND: Major Depressive Disorder (MDD) is one of the most disabling mental health problems worldwide. The Recovery Model emphasizes peer support to empower individuals with MDD, improve self-management, and patients' quality of life. Despite the demonstrated efficacy of peer-led interventions, further research is needed due to methodological limitations and variability in interventions across studies. Therefore, the objective of this trial is to evaluate the effectiveness of an adjuvant peer-led intervention for the reduction of depressive symptoms in individuals diagnosed with MDD attended in primary care mental health units. METHODS: A controlled, parallel, randomized clinical trial will be conducted. The intervention group (n = 35) will receive 6 weeks of peer-led sessions based on a peer support program drive whilst supervised by nurses, while the control group (n = 35) will use a mobile Health (mHealth) application for emotional wellness based on CBT for 6 weeks. Measurements will be collected at baseline, at 6 weeks, at 6 and 12 months after the intervention to evaluate post-intervention effects. The primary outcome is the reduction of depressive symptoms through the Beck Depression Inventory (BDI-II) after the intervention. Secondary outcomes will involve measures such as adherence to psychiatric treatment, quality of life, adherence to mediterranean diet, alcohol consumption and physical activity. DISCUSSION: We hypothesize that this peer-led intervention, in contrast to the mHealth, will show improvement in BDI-II score reduction of 6 points after six weeks, 6 and 12 months. Standardized peer-led programs can benefit patients and professionals in terms of efficacy and feasibility of clinical treatment of depression, healthy habits, self-care and quality of life. In addition, they can provide recovery and relapse reduction, improved psychosocial support, minimization of intensive care use, and support for patient autonomy through self-management. TRIAL REGISTRATION: The trial protocol is prospectively registered with ClinicalTrials.gov under protocol registration number NCT06398561. Date of registration: May 01, 2024. Recruitment is ongoing.
背景:重度抑郁症(MDD)是全球最具致残性的心理健康问题之一。康复模式强调同伴支持,以增强 MDD 患者的能力,改善自我管理,提高患者的生活质量。尽管同伴主导的干预措施已被证明有效,但由于研究之间的干预措施存在方法学限制和变异性,仍需要进一步研究。因此,本试验的目的是评估辅助性同伴主导干预对减少在初级保健心理健康单位接受治疗的 MDD 患者的抑郁症状的有效性。
方法:将进行一项对照、平行、随机临床试验。干预组(n=35)将接受 6 周的基于同伴支持计划的同伴主导课程,同时由护士监督,而对照组(n=35)将在 6 周内使用基于 CBT 的移动心理健康(mHealth)应用程序进行情绪健康管理。将在基线、6 周、干预后 6 个月和 12 个月进行测量,以评估干预后的效果。主要结局是通过贝克抑郁量表(BDI-II)评估干预后抑郁症状的减轻。次要结局将包括遵守精神科治疗、生活质量、遵守地中海饮食、饮酒和身体活动等措施。
讨论:我们假设与 mHealth 相比,这种同伴主导的干预措施将在 6 周、6 个月和 12 个月后显示出 BDI-II 评分降低 6 分的改善。标准化的同伴主导计划可以在疗效和临床治疗抑郁症、健康习惯、自我保健和生活质量的可行性方面使患者和专业人员受益。此外,它们可以通过自我管理提供康复和减少复发、改善心理社会支持、最大限度地减少重症监护的使用,并支持患者的自主性。
试验注册:试验方案前瞻性地在 ClinicalTrials.gov 上注册,注册号为 NCT06398561。注册日期:2024 年 5 月 1 日。正在招募参与者。
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