互联网 delivered 认知行为疗法治疗抑郁障碍门诊患者失眠障碍:一项随机对照试验方案。

Internet-delivered cognitive behavioural therapy for insomnia disorder in depressed patients treated at an outpatient clinic for mood disorders: protocol of a randomised controlled trial.

机构信息

GGZ inGeest, Specialized Mental Health Care, Amsterdam, The Netherlands.

Department of Psychiatry, Amsterdam UMC Location Vrije Universiteit Amsterdam, Boelelaan 1117, Amsterdam, The Netherlands.

出版信息

BMC Psychiatry. 2023 Jan 27;23(1):75. doi: 10.1186/s12888-022-04492-z.

DOI:10.1186/s12888-022-04492-z

PMID:36707843

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9880372/

Abstract

BACKGROUND

Major depression is a highly prevalent disorder causing severe personal distress, and high societal costs. Patients with depression often have comorbid insomnia disorder (ID) leading to even worse personal distress and worse treatment outcomes. Recent results from a non-randomised pilot study with internet-delivered Cognitive Behavioural Therapy (CBTi) for Insomnia (I-Sleep) added to regular depression care were promising regarding feasibility and initial effects on insomnia complaints and depression. However, no randomised controlled trial (RCT) has been performed yet to access the (cost-) effectiveness of I-Sleep for depression. Therefore, this protocol article presents the design of an RCT aimed to assess the (cost-) effectiveness of I-Sleep in addition to usual care for depression compared to usual care alone in depressed patients with a comorbid Insomnia Disorder (ID) treated at outpatient clinics for mood disorders. METHODS /DESIGN: This is a multi-centre RCT with measurements at baseline and at 3, 6, 9, and 12 months of follow-up. Patients with depression and an ID are randomised to either I-Sleep treatment followed by regular depression care or to regular depression care alone. Our aim is to recruit one hundred and seventy-five patients from multiple outpatient clinics for mood disorders. The primary outcome is the change in depressive symptoms over 12 months of follow-up measured with the Patient Health Questionnaire (PHQ-9). Secondary outcomes are recovery from depression (PHQ-9), insomnia severity (Insomnia Severity Index, ISI), daily functioning (Work and Social Adjustment Scale, WSAS), general quality of life (EuroQol 5-level version, EQ-5D-5L), and societal costs (Adapted versions of the iMTA Productivity Cost Questionnaire, iPCQ and iMTA Medical Cost Questionnaire, iMCQ).

DISCUSSION

We hypothesize that the addition of I-Sleep to usual care will result in a significant improvement in depression treatment outcomes and quality of life as well as a decrease in healthcare and societal costs compared to usual care alone. This study is the first pragmatic RCT evaluating the effectiveness and cost-effectiveness of adding CBTi to usual care for depression.

TRIAL REGISTRATION

Netherlands Trial Register (NL8955). Registered on October 62020. https://trialsearch.who.int/Trial2.aspx?TrialID=NL8955.

摘要

背景

重度抑郁症是一种高发疾病，会给患者带来严重的个人痛苦和高昂的社会成本。患有抑郁症的患者常伴有共病性失眠症（ID），这会导致更严重的个人痛苦和更差的治疗效果。最近，一项非随机试点研究的结果显示，针对失眠症的互联网认知行为疗法（CBTi）（I-Sleep）与常规抑郁症护理相结合具有较好的可行性和初步效果，可以改善失眠症和抑郁症。然而，目前尚未进行随机对照试验（RCT）来评估 I-Sleep 对抑郁症的（成本）有效性。因此，本文介绍了一项 RCT 的设计方案，旨在评估在接受门诊情绪障碍治疗的伴有共病失眠症（ID）的抑郁症患者中，与常规抑郁症护理相比，将 I-Sleep 添加到常规抑郁症护理中对抑郁症的（成本）有效性。

方法/设计：这是一项多中心 RCT，在基线和 3、6、9 和 12 个月的随访时进行测量。将患有抑郁症和 ID 的患者随机分配至 I-Sleep 治疗联合常规抑郁症护理或常规抑郁症护理。我们的目标是从多个门诊情绪障碍诊所招募 175 名患者。主要结局是在 12 个月的随访期间，用患者健康问卷（PHQ-9）测量的抑郁症状的变化。次要结局是抑郁症的恢复（PHQ-9）、失眠严重程度（失眠严重程度指数，ISI）、日常功能（工作和社会适应量表，WSAS）、一般生活质量（欧洲五维健康量表，EQ-5D-5L）和社会成本（IMTA 生产力成本问卷的适应版本，iPCQ 和 iMTA 医疗成本问卷，iMCQ）。