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B 阳性:双相情感障碍轻躁期患者多成分积极心理学干预的随机对照试验——研究方案和干预措施开发。

B-positive: a randomized controlled trial of a multicomponent positive psychology intervention for euthymic patients with bipolar disorder - study protocol and intervention development.

机构信息

Center for eHealth and Well-being Research, Department of Psychology, Health, and Technology, University of Twente, PO Box 217, Enschede, 7500 AE, the Netherlands.

Specialized Center for Bipolar Disorders, Dimence group, Pikeursbaan 3, Deventer, 7411 GT, the Netherlands.

出版信息

BMC Psychiatry. 2018 Oct 17;18(1):335. doi: 10.1186/s12888-018-1916-3.

Abstract

BACKGROUND

Bipolar disorder (BD) is characterized by recurrent (hypo)manic and depressive episodes, alternating with euthymic states in which patients are relatively symptom free. Besides clinical recovery, it is important to also strive for improvement of mental well-being and personal recovery. One prominent field focussing on the improvement of well-being is positive psychology. However, studies assessing the effects of positive psychology or personal recovery interventions for people with BD are scarce and have used weak methodological designs. The study described in this protocol article aims to assess the effectiveness of a multicomponent positive psychology intervention ("Living well with bipolar disorder") adjusted for people with BD in the euthymic phase to improve well-being and personal recovery.

METHOD

The study concerns a pragmatic randomized multicenter trial. The principle objective of the study is to assess whether the positive psychology intervention offered to BD patients in remission in addition to usual care (CAU) is more effective than CAU. The study will include 112 participants randomized to either the experimental condition receiving the intervention in addition to CAU or the control condition receiving CAU. The study population are patients with BD I or II in the euthymic phase. The inclusion criteria are 1) diagnosis of BD I or BD II, 2) between the ages of 18-65, 3) four or more supportive sessions in the last year, and 4) only residual depressive or manic symptoms. Patients are excluded if they are in a depressive or manic episode, have current addiction problems or have optimal levels of well-being. Measurements take place at baseline, post-intervention and follow-up 6 and 12 months from baseline. Outcomes of measures include positive well-being, personal recovery, psychopathology, self-compassion, positive relationships, dampening of positive affect and relapse.

DISCUSSION

The outlined study will be the first RCT examining the effects of a multicomponent positive psychology intervention for patients with bipolar disorder. Several limitations, including generalizability of the results and possible attrition issues, are discussed in advance.

TRIAL REGISTRATION

This study has been registered in the Netherlands Trial Register ( NTR6729 ) on 12 October 2017.

摘要

背景

双相情感障碍(BD)的特征是反复发作(轻)躁狂和抑郁发作,伴有相对无症状的轻躁期和缓解期。除了临床康复外,改善心理健康和个人康复也是很重要的。关注幸福感改善的一个突出领域是积极心理学。然而,评估积极心理学或个人康复干预对双相情感障碍患者影响的研究很少,而且使用了较弱的方法学设计。本研究方案旨在评估针对双相情感障碍缓解期患者的多成分积极心理学干预(“与双相情感障碍共存”)在改善幸福感和个人康复方面的有效性。

方法

该研究是一项实用的随机多中心试验。该研究的主要目的是评估在常规护理(CAU)之外为缓解期双相情感障碍患者提供的积极心理干预是否比 CAU 更有效。该研究将包括 112 名参与者,随机分为实验组(除 CAU 外还接受干预)或对照组(仅接受 CAU)。研究人群为处于缓解期的 I 型或 II 型双相情感障碍患者。纳入标准为:1)双相情感障碍 I 型或 II 型诊断;2)年龄在 18-65 岁之间;3)过去一年接受过 4 次或更多次支持性治疗;4)仅有残留的抑郁或躁狂症状。处于抑郁或躁狂发作期、有当前成瘾问题或有最佳幸福感的患者被排除在外。在基线、干预后和随访 6 个月和 12 个月时进行测量。测量的结果包括积极的幸福感、个人康复、精神病理学、自我同情、积极的人际关系、积极情绪的抑制和复发。

讨论

本研究将是第一个评估多成分积极心理学干预对双相情感障碍患者影响的 RCT。提前讨论了一些局限性,包括结果的可推广性和可能的流失问题。

试验注册

该研究于 2017 年 10 月 12 日在荷兰试验注册中心(NTR6729)注册。

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