Physiotherapy and Psychological Among Refugees From Syria

NCT03951909 | Unknown

• 1 other identifier: 2018/603
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Mental Health Impairment

Outcome Measures

Primary Outcomes (2)

• Change in body pain index using Body Pain Inventory

  Pain intensity measures through four questions: worst pain, least pain, average pain, pain right now). Each question can answers with 1 to 10 points and will be measured separately

  At recruitment, right before and after the intervention and 12 weeks afterwards

• Change in Impact of Events Scale

  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)

  At recruitment, right before and after the intervention and 12 weeks afterwards

Study Arms (2)

Active intervention

EXPERIMENTAL

Either Physiotherapy activity and awareness intervention (PAAI) or Teaching recovery techniques (TRT)

Behavioral: Physiotherapy activity and awareness intervention: PAAI; Behavioral: Psychological intervention: Teaching recovery techniques (TRT)

Waiting list

EXPERIMENTAL

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; Behavioral: Psychological intervention: Teaching recovery techniques (TRT)

Interventions

Physiotherapy activity and awareness intervention: PAAI BEHAVIORAL

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.

Active intervention; Waiting list

Psychological intervention: Teaching recovery techniques (TRT) BEHAVIORAL

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.

Active intervention; Waiting list

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Bergen: lead
• Norwegian Institute of Public Health: collaborator

Study Sites (1)

University of Bergen

Bergen, Hordaland, 5018, Norway

Location

Related Publications (2)

• Hasha W, Igland J, Fadnes LT, Kumar BN, Heltne UM, Diaz E. Effect of a self-help group intervention using Teaching Recovery Techniques to improve mental health among Syrian refugees in Norway: a randomized controlled trial. Int J Ment Health Syst. 2022 Sep 6;16(1):47. doi: 10.1186/s13033-022-00557-4.

  PMID: 36068576 DERIVED

• Hasha W, Fadnes LT, Igland J, Vardal R, Giusti LM, Stromme EM, Haj-Younes J, Heltne U, Kumar BN, Diaz E. Two interventions to treat pain disorders and post-traumatic symptoms among Syrian refugees: protocol for a randomized controlled trial. Trials. 2019 Dec 27;20(1):784. doi: 10.1186/s13063-019-3919-x.

  PMID: 31881990 DERIVED

Related Links

• Description of the CHART study, of which this project is the RCT part

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: May 16, 2019
• Study Start: July 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 1, 2025
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)