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临床试验/NCT03470779
NCT03470779已完成不适用

A Randomized Controlled Wait-list Pilot Study Examining the Feasibility and Impact of a Combined Psychotherapy and Physiotherapy Group Treatment Program for Survivors of Torture Incarcerated in an Adult Prison in Kurdistan, Iraq

Northwestern University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年4月19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
30
试验地点
1
主要终点
Hopkins Symptom Checklist-25

研究概览

简要总结

The aim of this study is to assess the impact and feasibility of an interdisciplinary group treatment approach, involving psychotherapy and physiotherapy, with survivors of torture that are incarcerated in a prison in Kurdistan, Iraq. The primary aim is to develop initial estimates of treatment effects on symptoms and poor functioning consistent with centralized pain and post-traumatic stress disorder, anxiety, and/or depression. The secondary aim is to assess the feasibility of studying this interdisciplinary treatment program in which local Kurdish psychotherapists and physiotherapists provide a 10-week intervention in a prison, in the Kurdish Sorani language, and to Kurdish participants that present with mental health symptoms, physical complaints, and poor functioning

详细描述

The aim of this randomized wait-list controlled pilot study is to assess the impact and feasibility of an interdisciplinary group treatment approach, involving psychotherapy and physiotherapy, with survivors of torture that are incarcerated in a prison in Kurdistan, Iraq. The primary aim is to develop initial estimates of treatment effects on symptoms and poor functioning consistent with centralized pain and post-traumatic stress disorder, anxiety, and/or depression. It is hypothesized that participants in the study will present with statistically significant improvements in some to all measures of symptoms and function. The secondary aim is to assess the feasibility of studying this interdisciplinary treatment program in which local Kurdish psychotherapists and physiotherapists provide a 10-week intervention in a prison, in the Kurdish Sorani language, and to Kurdish participants that present with mental health symptoms, physical complaints, and poor functioning

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Age equal to or greater than 18 years
  • Incarcerated in the reformatory where research is conducted
  • Native speaker of Sorani, a Kurdish language
  • History of torture is reported and documented during the psychotherapy intake
  • Presents with symptoms consistent with post-traumatic stress disorder, anxiety, and/or depression evident by a total score of greater than or equal to 1.75 on Hopkins Symptoms Checklist-25 and/or by a total score greater than or equal to 2.5 on the Harvard Trauma Questionnaire Part 4
  • Presents with symptoms consistent with centralized pain evident by a score of greater than or equal to 40 on the Central Sensitization Inventory Part A.

排除标准

  • Reports he will not remain in the current reformatory for at least 6 months from the onset of the study
  • Is unable to make the time commitment required to participate
  • Presents with symptoms consistent with a psychiatric condition which makes participation in the study unsafe for himself or others, based on the evaluation by the treating psychotherapist
  • Presents with a high risk to self or others which makes participation in the study unsafe for himself or others, based on evaluation by the treating psychotherapist
  • Participation is deemed unsafe due to a severe medical condition previously diagnosed by a medical doctor and/or signs/symptoms consistent with a possible medical condition based on the evaluation by the treating physiotherapist, 6.) reports previously receiving treatment by Wchan
  • Current substance abuse reported by participant or identified by treating psychotherapist
  • Currently receiving mental health services and/or physiotherapy services from other organization
  • Reports unresolvable conflict with participant/s enrolled in the study.

研究组 & 干预措施

Treatment group

Experimental

Participants randomly assigned to the treatment group will participate in an interdisciplinary treatment program in which local Kurdish psychotherapists and physiotherapists provide a 10-week intervention program. Treatment will consist of group physiotherapy and group psychotherapy

干预措施: Physiotherapy (Other)

Treatment group

Experimental

Participants randomly assigned to the treatment group will participate in an interdisciplinary treatment program in which local Kurdish psychotherapists and physiotherapists provide a 10-week intervention program. Treatment will consist of group physiotherapy and group psychotherapy

干预措施: Psychotherapy (Other)

Wait-list group

No Intervention

Participants randomly assigned to the wait-list group will not receive treatment but will participate in outcome data collection for comparison purposes.

结局指标

主要结局

Hopkins Symptom Checklist-25

时间窗: 10 weeks

The HSCL-25 is a 25-question symptom inventory which measures symptoms of anxiety and depression.

次要结局

  • Patient Specific Functional Scale(10-weeks)
  • Pittsburgh Sleep Quality Index(10-weeks)
  • Harvard Trauma Questionnaire Part 4(10 weeks)
  • Patient's Global Impression of Change Scale(10-weeks)
  • General Self Efficacy Scale(10-weeks)
  • Central Sensitization Inventory(10-weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeff Hartman

Assistant professor

Northwestern University

研究点 (1)

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