Physical Activity Intervention for Trauma Afflicted Refugees
Primary Purpose
PTSD, Depression, Anxiety, Physical Activity
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Physical activity intervention
Brief psycho-education
Sponsored by
About this trial
This is an interventional treatment trial for PTSD focused on measuring Mental health, Physical activity
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.
Sites / Locations
- The Swedish Red Cross Treatment Center for Persons affected by War and Torture (SRCTC)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Physical activity Intervention
Brief Psycho-education
Arm Description
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.
This arm receives two brief lectures of psycho-education held by a physiotherapist.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04065126
First Posted
May 2, 2019
Last Updated
May 4, 2022
Sponsor
Swedish Red Cross University College
Collaborators
Swedish Red Cross
1. Study Identification
Unique Protocol Identification Number
NCT04065126
Brief Title
Physical Activity Intervention for Trauma Afflicted Refugees
Official Title
Physical Activity Intervention for Trauma Afflicted Refugees
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 18, 2019 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swedish Red Cross University College
Collaborators
Swedish Red Cross
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Depression, Anxiety, Physical Activity
Keywords
Mental health, Physical activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physical activity Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Brief Psycho-education
Arm Type
Active Comparator
Arm Description
This arm receives two brief lectures of psycho-education held by a physiotherapist.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity intervention
Intervention Description
Ten sessions (two hours each) with physical activity and psycho-educational components.
Intervention Type
Behavioral
Intervention Name(s)
Brief psycho-education
Intervention Description
Two brief lectures with psycho-educational components, soon after baseline assessment and in connection to follow-up assessment.
Primary Outcome Measure Information:
Title
Change in symptoms of PTSD
Description
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.
Time Frame
Baseline, 10 weeks, three months, and six months
Secondary Outcome Measure Information:
Title
Emotional distress
Description
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.
Time Frame
Baseline, 10 weeks, three months, and six months
Title
Subjective well-being
Description
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.
Time Frame
Baseline, 10 weeks, three months, and six months
Title
Health related quality of life
Description
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.
Time Frame
Baseline, 10 weeks, three months, and six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fredrik Saboonchi, Professor
Organizational Affiliation
Swedish Red Cross University College
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Swedish Red Cross Treatment Center for Persons affected by War and Torture (SRCTC)
City
Malmö
ZIP/Postal Code
211 21
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
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Physical Activity Intervention for Trauma Afflicted Refugees
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