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Trial record 97 of 982 for:    scale | Norway

Physiotherapy and Psychological Among Refugees From Syria

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ClinicalTrials.gov Identifier: NCT03951909
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
Norwegian Institute of Public Health
Information provided by (Responsible Party):
University of Bergen

Brief Summary:

The war in Syria began in 2011 and refugees from this country have faced stressors including security risks, lack of access and availability of basic services and resources as well as family, community, and socio political tensions. Exposure to stressful events or situations, either short or long lasting, of exceptionally threatening or catastrophic nature is likely to cause pervasive distress in almost anyone, which might disturb daily life function, integration in society and ability to function in work and society, although this stress does not necessarily need to become an established medical diagnose. For a long time now, somatic and mental health systems have been overburdened and inaccessible both in Syria and in transit countries, and there is little available evidence of the effect of interventions targeting common health problems among refugees once established in their host countries.

In this project, the University of Bergen, in close collaboration with the Centre for Migration Health (Bergen municipality) and the Centre for Crisis Psychology, have developed two treatment interventions that are both theoretically sound and practically scalable if shown to be effective.

Among resettled asylum seekers and refugees, the primary aim of the project is to separately study in a quantitative way the effect on both physical and mental health of two different interventions: Physiotherapy activity and awareness intervention for participants with pain disorders and Teaching recovery techniques for participants with post-traumatic symptoms In addition, in a qualitative mode, our secondary aim is to analyse the processes by which the interventions help/do not help the patients to improve their health. Last, as the third aim of the study, cost effectiveness analyses will be conducted.


Condition or disease Intervention/treatment Phase
Pain Mental Health Impairment Behavioral: Physiotherapy activity and awareness intervention: PAAI Behavioral: Psychological intervention: Teaching recovery techniques (TRT) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants identified with pain disorders or post-traumatic mental health symptoms according to previously defined objective selection criteria will be invited to the appropriate treatment group conducted by physiotherapists (for those with pain disorders) or health professionals trained in TRT techniques (for those with post-traumatic symptoms). Participants presenting both pain and post-traumatic symptoms will be invited to the intervention treatment for the symptom in which they score highest.

For each group a waiting-list group receiving the same treatment some weeks later was the control group.

Masking: None (Open Label)
Masking Description: Neither the participant or th researcher knew the intervention assignment before enrollment, but there were no masking afterwards (when they had been assigned to either physiotherapy or TRT)
Primary Purpose: Treatment
Official Title: Effect of Physiotherapy and Psychological Group Treatment on Physical and Mental Health Among Refugees From Syria With Pain Disorders or Post-traumatic Symptoms
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: Active intervention
Either Physiotherapy activity and awareness intervention (PAAI) or Teaching recovery techniques (TRT)
Behavioral: Physiotherapy activity and awareness intervention: PAAI
10 to 12 persons will be invited to each group. The intervention will consist on 8 weekly sessions including the same key elements each time: introduction with a mindfulness exercise and a ball game, several movements while sitting on a chair, standing proprioceptive exercises with wooden sticks and exercises to raise awareness of muscle tensions in the body, active movements stimulating the balance, coordination and breathing and finally relaxation and a short closing round.

Behavioral: Psychological intervention: Teaching recovery techniques (TRT)
TRT is composed of five two-hour group teaching sessions with up to 15 participants. The first two sessions deal with intrusive thoughts and feelings: problems such as bad memories, nightmares, and flashbacks. The third session deals with arousal, coming to the surface as difficulties in relaxing, concentrating and sleeping. The fourth and fifth sessions deal with avoidance: ones fears, and difficulties in facing up to reminders of the war and violence.

Experimental: Waiting list
The same interventions as above will be hold for waiting lists participants, but after 6 to 8 weeks
Behavioral: Physiotherapy activity and awareness intervention: PAAI
10 to 12 persons will be invited to each group. The intervention will consist on 8 weekly sessions including the same key elements each time: introduction with a mindfulness exercise and a ball game, several movements while sitting on a chair, standing proprioceptive exercises with wooden sticks and exercises to raise awareness of muscle tensions in the body, active movements stimulating the balance, coordination and breathing and finally relaxation and a short closing round.

Behavioral: Psychological intervention: Teaching recovery techniques (TRT)
TRT is composed of five two-hour group teaching sessions with up to 15 participants. The first two sessions deal with intrusive thoughts and feelings: problems such as bad memories, nightmares, and flashbacks. The third session deals with arousal, coming to the surface as difficulties in relaxing, concentrating and sleeping. The fourth and fifth sessions deal with avoidance: ones fears, and difficulties in facing up to reminders of the war and violence.




Primary Outcome Measures :
  1. Change in body pain index [ Time Frame: At recruitment, right before and after the intervention and 12 weeks afterwards ]
    Pain intensity (worst pain, least pain, average pain, pain right now)

  2. Change in Impact of Events Scale [ Time Frame: At recruitment, right before and after the intervention and 12 weeks afterwards ]
    Scores in the Impact of Events-Revised scale. The revised version of the Impact of Event Scale has 22 questions and a scoring range of 0 to 88. Low scores are considered as better outcomes. Scores of 24 or more are of clinical concern and 33 and above is the cutoff for a probable diagnoses of post traumatic stress disorder(PTSD)



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• Patients who answer yes to the question "Have you experienced any of these or some other terrifying event(s)?" and score over 24 in the revised Impact of Events Scale (R-IES) will be invited to the TRT-intervention.

Exclusion Criteria:

  • Patients who report health conditions requiring close medical follow up
  • Patients who score in the mental health questions as having a serious mental illness (37 + in the revised Impact of Events Scale or 25 or more in the GHQ-12)
  • Patients with a living situation that impedes following up (including no current address close to Bergen).

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): NCT03951909


Locations
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Norway
University of Bergen Recruiting
Bergen, Hordaland, Norway, 5018
Contact: Esperanza Diaz, MD, PhD    47414104    esperanza.diaz@uib.no   
Sponsors and Collaborators
University of Bergen
Norwegian Institute of Public Health

Additional Information:
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Responsible Party: University of Bergen
ClinicalTrials.gov Identifier: NCT03951909     History of Changes
Other Study ID Numbers: 2018/603
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Sensitive information. Not allowed to share by the Ethical committee

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No