Physical Activity Intervention for Trauma Afflicted Refugees

Physical Activity Clinical Trial

Official title:

Physical Activity Intervention for Trauma Afflicted Refugees

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04065126
• Other study ID #: 2017/1174-31
• Status: Completed
• Phase: N/A
• Start date: August 28, 2018
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2024
• Source: Swedish Red Cross University College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety
• Physical Activity
• PTSD

Intervention

Behavioral:
• Physical activity intervention
Ten sessions (two hours each) with physical activity and psycho-educational components.
• Brief psycho-education
Two brief lectures with psycho-educational components, soon after baseline assessment and in connection to follow-up assessment.

Locations

Country	Name	City	State
Sweden	The Swedish Red Cross Treatment Center for Persons affected by War and Torture (SRCTC)	Malmö

Sponsors (2)

Lead Sponsor	Collaborator
Swedish Red Cross University College	Swedish Red Cross

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Emotional distress	Change in emotional distress (depression and anxiety) assessed by the Hopkins Symptom Checklist (HSCL-25, 25 items). HSCL-25 consists of 10 anxiety and 15 depression items. The items, which refer to how specific symptoms have bothered or distressed the individual during the last week, have four response alternatives ranging from 'not at all' (1) to 'very much' (4). Individual mean item scores will be calculated separately for the anxiety and depression subscales. Respondents with a mean item score above 1.80 and 1.75 classifies as having depression or anxiety, respectively.	Baseline, 10 weeks, and six months
Secondary	Subjective well-being	Change in subjective well-being (SWB) assessed by WHO-5 Well-being Index (WHO-5) (5 items). WHO-5 contains five statements of the type 'I have felt happy and in a good mood' and the response alternatives range from 'all the time' (5) to 'never' (0) in relation to the last 2 weeks. The highest possible value of that scale is 100, as the total score is multiplied by a factor of four. Those with values below 50 are classified as having low SWB.	Baseline, 10 weeks, and six months
Secondary	Health related quality of life	Change in general health, health-related quality of life, assessed by the EuroQol 5 dimenstions, 5 levels (EQ-5D-5L) (5 items). This instrument consists of a descriptive system including the following five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and each dimension has five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The respondent's answer on each of the five dimensions results in a one-digit number indicating the level selected for that dimension. The digits for the five dimensions are combined in a five-digit number describing the respondent's health state. The health states may be converted into a single index value between zero and one, where zero being equal to death and one being equal to a state of perfect health.	Baseline, 10 weeks, and six months