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Physical Activity Intervention for Trauma Afflicted Refugees

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04065126
Recruitment Status : Enrolling by invitation
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
Swedish Red Cross
Information provided by (Responsible Party):
Swedish Red Cross University College

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.

Condition or disease Intervention/treatment Phase
PTSD Depression, Anxiety Physical Activity Behavioral: Physical activity intervention Behavioral: Brief psycho-education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physical Activity Intervention for Trauma Afflicted Refugees
Actual Study Start Date : February 18, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


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

Active Comparator: Brief Psycho-education
This arm receives two brief lectures of psycho-education held by a physiotherapist.
Behavioral: Brief psycho-education
Two brief lectures with psycho-educational components, soon after baseline assessment and in connection to follow-up assessment.




Primary Outcome Measures :
  1. Change in symptoms of PTSD [ Time Frame: Baseline, 10 weeks, three months, and six months ]
    Change in symptoms of PTSD assessed by the Harvard Trauma Questionnaire (HTQ). In HTQ, the first 16 symptoms from section IV are used to identify individuals with PTSD. 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). Mean item scores are calculated and the mean item score of 2.06 are used to distinguish cases of PTSD from non-cases.


Secondary Outcome Measures :
  1. Emotional distress [ Time Frame: Baseline, 10 weeks, three months, 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.

  2. Subjective well-being [ Time Frame: Baseline, 10 weeks, three months, 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.

  3. Health related quality of life [ Time Frame: Baseline, 10 weeks, three months, and six months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065126


Locations
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Sweden
The Swedish Red Cross Treatment Center for Persons affected by War and Torture (SRCTC)
Malmö, Sweden, 211 21
Sponsors and Collaborators
Swedish Red Cross University College
Swedish Red Cross
Investigators
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Principal Investigator: Fredrik Saboonchi, Professor Swedish Red Cross University College
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Responsible Party: Swedish Red Cross University College
ClinicalTrials.gov Identifier: NCT04065126    
Other Study ID Numbers: 2017/1174-31
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Swedish Red Cross University College:
Mental health
Physical activity
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms