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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03470779
• Date of registration: 13/03/2018
• Prospective Registration: Yes
• Primary sponsor: Northwestern University
• Public title: Impact of Combined Psychotherapy and Physiotherapy Group Treatment Program for Survivors of Torture
• Scientific 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
• Date of first enrolment: April 19, 2018
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03470779
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Iraq

Contacts

• Name: Jeff A Hartman, DPT, MPH
• Affiliation: Northwestern University

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 100 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Disability Physical

Pain Syndrome

Intervention(s)

Other: Physiotherapy

Other: Psychotherapy

Primary Outcome(s)

Hopkins Symptom Checklist-25 [Time Frame: 10 weeks]

Secondary Outcome(s)

Patient's Global Impression of Change Scale [Time Frame: 10-weeks]

General Self Efficacy Scale [Time Frame: 10-weeks]

Harvard Trauma Questionnaire Part 4 [Time Frame: 10 weeks]

Patient Specific Functional Scale [Time Frame: 10-weeks]

Central Sensitization Inventory [Time Frame: 10-weeks]

Pittsburgh Sleep Quality Index [Time Frame: 10-weeks]

Secondary ID(s)

STU00206726

Source(s) of Monetary Support

Please refer to primary and secondary sponsors