Impact of Combined Psychotherapy and Physiotherapy Group Treatment Program for Survivors of Torture

NCT03470779 | Completed

• 1 other identifier: STU00206726
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Pain Syndrome; Disability Physical

Outcome Measures

Primary Outcomes (1)

• Hopkins Symptom Checklist-25

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

  10 weeks

Secondary Outcomes (6)

• Patient Specific Functional Scale

  10-weeks

• Pittsburgh Sleep Quality Index

  10-weeks

• Patient's Global Impression of Change Scale

  10-weeks

• General Self Efficacy Scale

  10-weeks

• Central Sensitization Inventory

  10-weeks

Study Arms (2)

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

Other: Physiotherapy; Other: Psychotherapy

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.

Interventions

Physiotherapy OTHER

Treatment group participants will participate in weekly group physiotherapy and psychotherapy sessions as part of the standard program procedure.

Treatment group

Psychotherapy OTHER

Treatment group participants will participate in weekly group physiotherapy and psychotherapy sessions as part of the standard program procedure.

Treatment group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: This program and study are being administered in an all-male reformatory. Thus, only men are being studied.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Sulaymaniyah Adult Male Reformatory

Sulaymaniyah, Kurdistan, Iraq

Location

MeSH Terms

Conditions

Somatoform Disorders

Interventions

Physical Therapy Modalities; Psychotherapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Behavioral Disciplines and Activities

Study Officials

• Jeff A Hartman, DPT, MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: The study design is a randomized, wait-list controlled pilot study. A parallel group study design will be used to compare a treatment group and a wait-list control group. This study design will be effective for addressing the gap in literature by examining both the initial treatment estimates related to health and functioning and the feasibility of performing a similar study on a larger scale.

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 20, 2018
• Study Start: April 19, 2018
• Primary Completion: November 15, 2018
• Study Completion: January 1, 2019
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

IR (1)