Physical Activity Intervention for Trauma Afflicted Refugees
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|ClinicalTrials.gov Identifier: NCT04065126|
Recruitment Status : Enrolling by invitation
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|PTSD Depression, Anxiety Physical Activity||Behavioral: Physical activity intervention Behavioral: Brief psycho-education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
- 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.
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
|The Swedish Red Cross Treatment Center for Persons affected by War and Torture (SRCTC)|
|Malmö, Sweden, 211 21|
|Principal Investigator:||Fredrik Saboonchi, Professor||Swedish Red Cross University College|