Physical Activity Intervention for Trauma Afflicted Refugees

NCT04065126 | Completed

• 1 other identifier: 2017/1174-31
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effects of a 10-session physical activity intervention for trauma afflicted refugees. Half of participants will receive this 10-session physical activity intervention and half of the participants will be allocated to the control group.

Conditions

PTSD; Depression, Anxiety; Physical Activity

Keywords

Mental health; Physical activity

Outcome Measures

Primary Outcomes (1)

• Change in symptoms of PTSD

  Change in symptoms of PTSD measured by the Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5). The PCL-5 is a self-report questionnaire comprising 20 items relating to the main symptoms of PTSD, and which may be divided into the four symptom clusters of PTSD; intrusion, hyperarousal/reactivity, avoidance, and negative alterations in cognitions and mood. Scores range between 0-80. Higher score indicate worse outcome. Initial research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD across samples.

  Baseline, 10 weeks, and six months

Secondary Outcomes (3)

• Emotional distress

  Baseline, 10 weeks, and six months

• Subjective well-being

  Baseline, 10 weeks, and six months

• Health related quality of life

  Baseline, 10 weeks, and six months

Study Arms (2)

Physical activity Intervention

EXPERIMENTAL

This arm receives ten two-hour group sessions with physical activity and psycho-educational components, held by a physiotherapist over a period of ten weeks.

Behavioral: Physical activity intervention

Brief Psycho-education

ACTIVE COMPARATOR

This arm receives two brief lectures of psycho-education held by a physiotherapist.

Behavioral: Brief psycho-education

Interventions

Physical activity intervention BEHAVIORAL

Ten sessions (two hours each) with physical activity and psycho-educational components.

Physical activity Intervention

Brief psycho-education BEHAVIORAL

Two brief lectures with psycho-educational components, soon after baseline assessment and in connection to follow-up assessment.

Brief Psycho-education

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Arabic/Persian speaking persons.
• Persons with refugee background referred to the Swedish Red Cross Treatment Center for trauma related to war and/or torture.
• Person able to undertake physical activity in a group setting.

You may not qualify if:

• Current serious suicidal ideation, psychosis, serious cognitive impairments, current substance abuse, acute physical injuries or other health conditions that constrain physical activity.

Sponsors & Collaborators

• Swedish Red Cross University College: lead
• Swedish Red Cross: collaborator

Study Sites (1)

The Swedish Red Cross Treatment Center for Persons affected by War and Torture (SRCTC)

Malmo, 211 21, Sweden

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Anxiety Disorders; Motor Activity; Psychological Well-Being

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Fredrik Saboonchi, Professor

  Swedish Red Cross University College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: August 22, 2019
• Study Start: August 28, 2018
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)