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

Disability Physical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03470779
• Other study ID #: STU00206726
• Status: Completed
• Phase: N/A
• Start date: April 19, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: March 2019
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 1, 2019
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disability Physical
• Pain Syndrome

Intervention

Other:
• Physiotherapy
Treatment group participants will participate in weekly group physiotherapy and psychotherapy sessions as part of the standard program procedure.
• Psychotherapy
Treatment group participants will participate in weekly group physiotherapy and psychotherapy sessions as part of the standard program procedure.

Locations

Country	Name	City	State
Iraq	Sulaymaniyah Adult Male Reformatory	Sulaymaniyah	Kurdistan

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hopkins Symptom Checklist-25	The HSCL-25 is a 25-question symptom inventory which measures symptoms of anxiety and depression.	10 weeks
Secondary	Patient Specific Functional Scale	This useful questionnaire can be used to quantify activity limitation and measure functional outcome for patients with any orthopaedic condition.	10-weeks
Secondary	Pittsburgh Sleep Quality Index	The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults.	10-weeks
Secondary	Patient's Global Impression of Change Scale	The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment	10-weeks
Secondary	General Self Efficacy Scale	The General Self-Efficacy Scale is a 10-item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life.	10-weeks
Secondary	Central Sensitization Inventory	This tool was published with the purpose of providing a single self-report instrument that identified symptoms associated with central sensitization and the quantified the degree of those symptoms.	10-weeks
Secondary	Harvard Trauma Questionnaire Part 4	The Harvard Trauma Questionnaire (HTQ) is a checklist that inquires about a variety of trauma events, as well as the emotional symptoms considered to be uniquely associated with trauma.	10 weeks