## Protocol Section
### Identification Module
**NCT ID:** NCT03470779

**Brief Title:** 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

#### Organization Study ID Info
**ID:** STU00206726
#### Organization
**Class:** OTHER
**Full Name:** Northwestern University
### Status Module
#### Completion Date
**Date:** 2019-01-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-03-13

**Type:** ACTUAL

**Last Update Submit Date:** 2019-03-11

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-11-15

**Type:** ACTUAL

#### Start Date
**Date:** 2018-04-19

**Type:** ACTUAL

**Status Verified Date:** 2019-03

#### Study First Post Date
**Date:** 2018-03-20
**Type:** ACTUAL
**Study First Submit Date:** 2018-03-13
**Study First Submit QC Date:** 2018-03-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Northwestern University

#### Responsible Party

**Investigator Affiliation:** Northwestern University

**Investigator Full Name:** Jeff Hartman

**Investigator Title:** Assistant professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Pain Syndrome

- Disability Physical

### Design Module

#### Design Info

**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.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Other: Physiotherapy

- Other: Psychotherapy

**Label:** Treatment group

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Label:** Wait-list group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treatment group

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

**Name:** Physiotherapy

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Treatment group

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

**Name:** Psychotherapy

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Hopkins Symptom Checklist-25

**Time Frame:** 10 weeks

#### Secondary Outcomes

**Description:** This useful questionnaire can be used to quantify activity limitation and measure functional outcome for patients with any orthopaedic condition.

**Measure:** Patient Specific Functional Scale

**Time Frame:** 10-weeks

**Description:** The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults.

**Measure:** Pittsburgh Sleep Quality Index

**Time Frame:** 10-weeks

**Description:** The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment

**Measure:** Patient's Global Impression of Change Scale

**Time Frame:** 10-weeks

**Description:** 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.

**Measure:** General Self Efficacy Scale

**Time Frame:** 10-weeks

**Description:** 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.

**Measure:** Central Sensitization Inventory

**Time Frame:** 10-weeks

**Description:** 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.

**Measure:** Harvard Trauma Questionnaire Part 4

**Time Frame:** 10 weeks

### Eligibility Module

**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.

**Gender Based:** True

**Gender Description:** This program and study are being administered in an all-male reformatory. Thus, only men are being studied.

**Maximum Age:** 100 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Sulaymaniyah

**Country:** Iraq

**Facility:** Sulaymaniyah Adult Male Reformatory

**State:** Kurdistan

#### Overall Officials

**Official 1:**

**Affiliation:** Northwestern University

**Name:** Jeff A Hartman, DPT, MPH

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** Still in deliberation

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
