Physical Activity Intervention for Trauma Afflicted Refugees

NCT ID: NCT04065126

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-28
• Study Completion Date: 2023-06-30

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.

Detailed Description

Physical activity, particularly when performed in social settings, has been found to constitute an effective stress reliever and has been associated with improved physical and mental well-being, functional capacity and overall life satisfaction, as well as decreased risk of lifestyle diseases in various populations. Physical activity can also revert symptoms of psychiatric disorders such as depression, anxiety, social isolation and dissociation, which is common among trauma afflicted refugees. Many refugees also suffer from PTSD, and so the investigator's aim is to evaluate what effect a 10-session physical activity intervention will have on the mental and physical health of trauma afflicted refugees in a northern European country. The sessions will include physical exercise as well as psychoeducational components, and will be held by a physiotherapist over a period of ten weeks. The physical activity intervention group will be compared to a control-group, who receives two brief lectures on psycho-education in connection to baseline-assessment and follow-up.

Conditions

PTSD; Depression, Anxiety; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physical activity Intervention

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.

Group Type: EXPERIMENTAL

Physical activity intervention

Intervention Type: BEHAVIORAL

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

Brief Psycho-education

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

Group Type: ACTIVE_COMPARATOR

Brief psycho-education

Intervention Type: BEHAVIORAL

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

Interventions

Physical activity intervention

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

Intervention Type: BEHAVIORAL

Brief psycho-education

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swedish Red Cross

UNKNOWN

Sponsor Role: collaborator

Swedish Red Cross University College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fredrik Saboonchi, Professor

Role: PRINCIPAL_INVESTIGATOR

Swedish Red Cross University College

Locations

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

Malmo, , Sweden

Countries

Sweden

Other Identifiers

2017/1174-31

Identifier Type: -

Identifier Source: org_study_id