PTSDNCT04065126
Physical Activity Intervention for Trauma Afflicted Refugees
A study testing Physical activity intervention and Brief psycho-education in people with PTSD and Depression, Anxiety, run by Swedish Red Cross University College at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- PTSD, Depression, Anxiety, Physical Activity
- What is being tested?
- Physical activity intervention and Brief psycho-education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteSweden
- Study dates
- 28 Aug 2018to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Current serious suicidal ideation, psychosis, serious cognitive impairments, current substance abuse, acute physical injuries or other health conditions that constrain physical activity.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
The Swedish Red Cross Treatment Center for Persons affected by War and Torture (SRCTC)
Malmö, 211 21
About this study
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.
Read the 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.
- Conditions
- PTSD, Depression, Anxiety, Physical Activity
- Being tested
- Physical activity intervention, Brief psycho-education
- Keywords
- Mental health, Physical activity
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders, Motor Activity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity interventionBehavioural
Ten sessions (two hours each) with physical activity and psycho-educational components.
Brief psycho-educationBehavioural
Two brief lectures with psycho-educational components, soon after baseline assessment and in connection to follow-up assessment.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity Intervention | Experimental | 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. Receives: Behavioral: Physical activity intervention |
| Brief Psycho-education | Active comparator | This arm receives two brief lectures of psycho-education held by a physiotherapist. Receives: Behavioral: Brief psycho-education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 10 weeks, and six months
Secondary outcomes (3)
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.
Measured: Baseline, 10 weeks, and six months
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.
Measured: Baseline, 10 weeks, and six months
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.
Measured: Baseline, 10 weeks, and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start28 Aug 2018
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Red Cross University College
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Red Cross
- Responsible party
- Sponsor
- Investigators
- Fredrik Saboonchi, Professor, Principal investigator, Swedish Red Cross University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065126
- Sponsor's protocol ID
- 2017/1174-31
- Status last verified
- Feb 2024
- First submitted
- 2 May 2019
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Intervention for Trauma Afflicted Refugees
- ClinicalTrials.gov ID
- NCT04065126
- Acronym / sponsor ID
- 2017/1174-31
- Conditions
- PTSD, Depression, Anxiety, Physical Activity
- Keywords
- Mental health, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Swedish Red Cross University CollegeUniversity, hospital or other
- Collaborators
- Swedish Red Cross
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 22 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity Intervention | Experimental | Behavioral: Physical activity interventionThis arm receives ten two-hour group sessions with physical activity and psycho-educational components, held by a physiotherapist over a period of ten weeks. |
| Brief Psycho-education | Active comparator | Behavioral: Brief psycho-educationThis arm receives two brief lectures of psycho-education held by a physiotherapist. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Current serious suicidal ideation, psychosis, serious cognitive impairments, current substance abuse, acute physical injuries or other health conditions that constrain physical activity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity interventionTen sessions (two hours each) with physical activity and psycho-educational components. | Behavioural | Physical activity Intervention |
| Brief psycho-educationTwo brief lectures with psycho-educational components, soon after baseline assessment and in connection to follow-up assessment. | Behavioural | Brief Psycho-education |
Primary outcome
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.
3 secondary outcomes
Emotional distress
Time frame: Baseline, 10 weeks, and six months
Subjective well-being
Time frame: Baseline, 10 weeks, and six months
Health related quality of life
Time frame: Baseline, 10 weeks, and six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fredrik Saboonchi, Professor principal investigator
Swedish Red Cross University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity intervention and Brief psycho-education in people with PTSD and Depression, Anxiety, run by Swedish Red Cross University College at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptoms of PTSD (time frame: Baseline, 10 weeks, and six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.