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

NCT ID: NCT03470779

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-19
• Study Completion Date: 2019-01-01

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

Conditions

Pain Syndrome; Disability Physical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

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

Group Type: EXPERIMENTAL

Physiotherapy

Intervention Type: OTHER

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

Psychotherapy

Intervention Type: OTHER

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

Wait-list group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physiotherapy

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

Intervention Type: OTHER

Psychotherapy

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Jeff Hartman

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeff A Hartman, DPT, MPH

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Sulaymaniyah Adult Male Reformatory

Sulaymaniyah, Kurdistan, Iraq

Countries

Iraq

Other Identifiers

STU00206726

Identifier Type: -

Identifier Source: org_study_id