- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04065126
Physical Activity Intervention for Trauma Afflicted Refugees
February 19, 2024 updated by: Swedish Red Cross University College
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
183
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Malmö, Sweden, 211 21
- The Swedish Red Cross Treatment Center for Persons affected by War and Torture (SRCTC)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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Ten sessions (two hours each) with physical activity and psycho-educational components.
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Active Comparator: Brief Psycho-education
This arm receives two brief lectures of psycho-education held by a physiotherapist.
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Two brief lectures with psycho-educational components, soon after baseline assessment and in connection to follow-up assessment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in symptoms of PTSD
Time Frame: Baseline, 10 weeks, and six months
|
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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Emotional distress
Time Frame: Baseline, 10 weeks, and six months
|
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.
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Baseline, 10 weeks, and six months
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Subjective well-being
Time Frame: Baseline, 10 weeks, and six months
|
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.
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Baseline, 10 weeks, and six months
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Health related quality of life
Time Frame: Baseline, 10 weeks, and six months
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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.
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Baseline, 10 weeks, and six months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Fredrik Saboonchi, Professor, Swedish Red Cross University College
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 28, 2018
Primary Completion (Actual)
June 30, 2023
Study Completion (Actual)
June 30, 2023
Study Registration Dates
First Submitted
May 2, 2019
First Submitted That Met QC Criteria
August 21, 2019
First Posted (Actual)
August 22, 2019
Study Record Updates
Last Update Posted (Estimated)
February 21, 2024
Last Update Submitted That Met QC Criteria
February 19, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/1174-31
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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