Clinical trial NCT03470779: Impact of Combined Psychotherapy and Physiotherapy Group Treatment Program for Survivors of Torture
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Syndrome
Disability Physical
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Hopkins Symptom Checklist-25
timeFrame: 10 weeks
Secondary outcomes:
measure: Patient Specific Functional Scale
timeFrame: 10-weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: 10-weeks
measure: Patient's Global Impression of Change Scale
timeFrame: 10-weeks
measure: General Self Efficacy Scale
timeFrame: 10-weeks
measure: Central Sensitization Inventory
timeFrame: 10-weeks
measure: Harvard Trauma Questionnaire Part 4
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Sulaymaniyah
country: Iraq
facility: Sulaymaniyah Adult Male Reformatory
state: Kurdistan
Study officials:
affiliation: Northwestern University
name: Jeff A Hartman, DPT, MPH
role: PRINCIPAL_INVESTIGATOR
References: