Impact of Combined Psychotherapy and Physiotherapy Group... | NCT03470779

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

NCT03470779

Sponsor

Northwestern University

Status

Completed

Last Update Posted

Mar 13, 2019Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Pain Syndrome
Disability Physical

Interventions

Physiotherapy
Psychotherapy

Countries

Iraq

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 19, 2018Actual

Primary Completion Date

Nov 15, 2018Actual

Completion Date

Jan 1, 2019Actual

First Submitted Date

Mar 13, 2018

First Submission Date that Met QC Criteria

Mar 13, 2018

First Posted Date

Mar 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2019

Last Update Posted Date

Mar 13, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Physiotherapy	Other	Treatment group participants will participate in weekly group physiotherapy and psychotherapy sessions as part of the standard program procedure.	Treatment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hopkins Symptom Checklist-25	The HSCL-25 is a 25-question symptom inventory which measures symptoms of anxiety and depression.	10 weeks

Secondary Outcomes

Measure	Description	Time Frame
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
Pittsburgh Sleep Quality Index

Other Outcomes

Not provided

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

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

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jeff A Hartman, DPT, MPH	Northwestern University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Sulaymaniyah Adult Male Reformatory		Sulaymaniyah	Kurdistan		Iraq

ID	Term
D013001	Somatoform Disorders

ID	Term
D001523	Mental Disorders

ID	Term
D026741	Physical Therapy Modalities
D011613	Psychotherapy

ID	Term
D013812	Therapeutics
D012046	Rehabilitation
D004191	Behavioral Disciplines and Activities

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.