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临床试验/NCT03299127
NCT03299127已完成不适用

A Self-help Manual of Imagery Rescripting Reduces Depressive Symptoms

Universitätsklinikum Hamburg-Eppendorf2 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2017年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
127
试验地点
2
主要终点
Beck Depression Inventory II

研究概览

简要总结

Depression is among the world's leading causes of disability. To fill the existing treatment gap, psychological online interventions (POIs) and Internet-based treatment, including bibliotherapy with PDF manuals (POIs), are increasingly recommended as they are easily accessible and deemed an initial alternative approach. The present trial aims to evaluate imagery rescripting. With the help of various techniques, the approach aims to edit negative memories and rewrite a "happy end". To the best of our knowledge, imagery rescripting has never been tested as a self-help intervention. A large sample of patients with primary or secondary depression (N = 120) will be recruited and randomly allocated to either the intervention group or a wait-list control group. The intervention group consists of two subgroups that will receive either a full or brief version of a manual teaching them imagery rescripting. Participants will be assessed at baseline and six weeks later. A follow-up assessment will be completed six months later. The primary outcome measure is the Beck Depression Inventory II.

详细描述

Depression is among the world's leading causes of disability. Effective pharmacological and psychotherapeutic treatments exist. However, only a subgroup of individuals with depressive symptoms receive proper treatment (Kohn, Saxena, Levav, & Saraceno, 2004). To fill the existing treatment gap (Kazdin, 2017), psychological online interventions (POIs) and Internet-based treatment, including bibliotherapy with PDF manuals (POIs), are increasingly recommended as they are easily accessible and deemed an initial alternative approach (i.e., "foot in the door") for persons who have reservations about face-to-face psychotherapy. E-mental health and bilbiotherapeutic interventions have yielded promising results, but there remains room for improvement as effect sizes are usually in the small to medium range. The present trial aims to evaluate imagery rescripting, a technique developed by Smucker (Smucker, Dancu, Foa, & Niederee, 1995). With the help of various techniques, the approach aims to edit negative memories and rewrite a "happy end". Positive mental imagery strategies seek to hold negative mental images in check and impart the patient with a feeling of self-efficacy. A new meta-analysis shows that imagery rescripting yields large effects on anxiety and depressive symptoms across a range of disorders (Morina, Lancee, & Arntz, 2017).

To the best of our knowledge, imagery rescripting has never been tested as a self-help intervention. A large sample of patients with primary or secondary depression (N = 120) will be recruited and randomly allocated to either the intervention group or a wait-list control group. The intervention group consists of two subgroups that will receive either a full or brief version of a manual teaching them imagery rescripting. Participants will be assessed at baseline and six weeks later. At post-assessment, the (full-length) manual will be made available to all participants. A follow-up assessment will be completed six months later. The primary outcome measure is the Beck Depression Inventory II. Secondary outcome measures include self-reported symptom measures (PHQ-9, GAF-7, Rosenberg Self-Esteem Scale, Global item from the WHOQOL-BREF). The project may help to answer the question of whether imagery rescripting is effective when presented using a self-help medium.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

self-report serves as outcomes, patients are not masked

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Electronic informed consent
  • Internet access
  • Adequate command of the German language
  • Diagnosis of depression (primary or secondary)

排除标准

  • Acute suicidality

研究组 & 干预措施

imagery rescripting

Experimental

bibliotherapy, intervention is provided by pdf-manual (either short or long version, i.e. 2 active arms, each 1/3 of sample receives either short or long version)

干预措施: imagery rescripting (Behavioral)

wait-list control

No Intervention

wait-list control, participants receive intervention manual upon completion of post-assessment (1/3 of sample)

结局指标

主要结局

Beck Depression Inventory II

时间窗: Change in BDI-II from pre- to post-intervention (i.e. 6 week interval)

Beck Depression Inventory II (BDI II) (Beck, Steer, \& Brown, 1996). The BDI-II is a self-report scale that contains 21 Items that tap into cognitive, behavioral and somatic symptoms of depression. A follow-up assessment after six month serves as secondary outcome.

次要结局

  • Generalized Anxiety Disorders 7 (GAD-7)(Change from pre- to post-intervention (i.e. 6 week interval))
  • Patient Health Questionnaire (PHQ-9)(Change from pre- to post-intervention (i.e. 6 week interval))
  • Rosenberg Self-Esteem Scale (RSE)(Change from pre- to post-intervention (i.e. 6 week interval))
  • Global item of the WHO Quality of Life scale (WHOQOL-BREF)(Change from pre- to post-intervention (i.e. 6 week interval))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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