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Clinical Trials/NCT03470779
NCT03470779
Completed
Not Applicable

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 site in 1 country30 target enrollmentApril 19, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain Syndrome
Sponsor
Northwestern University
Enrollment
30
Locations
1
Primary Endpoint
Hopkins Symptom Checklist-25
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
April 19, 2018
End Date
January 1, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jeff Hartman

Assistant professor

Northwestern University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Hopkins Symptom Checklist-25

Time Frame: 10 weeks

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

Secondary Outcomes

  • 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)

Study Sites (1)

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