Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03951909 |
| Other study ID # |
2018/603 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2018 |
| Est. completion date |
December 2025 |
Study information
| Verified date |
November 2023 |
| Source |
University of Bergen |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Introduction Syria is now the 11th country of origin for immigrants in Norway. During the
last two years, the numbers of asylum seekers from Syria with permanent refugee status have
rapidly grown from 9700 in 2016 to a total of 20800 registered by the 1st of January 2017.
Given that more than 1 million Syrians applied for asylum in Europe between April and
December 2017, the numbers are probably going to continue growing also in Norway in the
months to come.
Impact of stress on health 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. Although our knowledge of the health
needs of refugees is still incomplete, several studies suggest a high degree of chronic pain
disorders and mental health symptoms as a result of the previous factors.
Arthrosis, arthritis and other forms for chronic pain are especially disabling among the
chronic non-communicable diseases and have previously been described to be related to mental
health problems. Though there is a lack of data regarding these conditions, some available
studies point to a relatively high prevalence among refugees from Syria. Just to point out
some examples: Among young Syrian refugees attending an emergency department in Austria
between 2011 and 2014, 12% presented chronic musculoskeletal problems and 9% suffered from
chronic headaches. A cross-sectional survey of 1550 refugees conducted outside of camps in
Jordan found a prevalence of 7% of arthritis. In the previously referred paper on elderly
Syrians, 47% reported difficulty walking.
Regarding mental problems, 61% of older refugees from Syria living in Lebanon in 2011-2013
reported feeling anxious, and significant proportions reported feelings of depression,
loneliness, and believing they were a burden to their families. In another study, 44% of 310
Syrian forced migrants in Lebanon in 2011 suffered from depression. In 2014, 54% of Syrians
accessing International Medical Corps facilities in Syria and neighbouring countries suffered
severe emotional disorders, including depression and anxiety.
Once resettled in Norway, the municipalities have the responsibility to offer adequate health
care services to refugees in need of health care. However, lack of evidence regarding the
best treatment together with limited resources may compromise the offer given to refugees.
Group treatment can be a strategy to maximize the effect of the treatment given the resources
typically available at the municipalities for this group of patients, as well as a mean to
increase social interaction and well-being among participants.
Evidence on group-based physiotherapy on chronic pain among refugees is scarce. A study using
basic body awareness therapy versus mixed physical activity for refugees with post traumatic
stress disease (PSTD) is on-going in Denmark, but the authors chose to give personal
treatment as opposed to group treatment due to a higher level of disease among their included
participants. Norwegian group psychomotor physiotherapy and general physiotherapy exercises,
on the other side, are well known and used in the Nordic countries. By using the knowledge of
the body and reactions after trauma, the physiotherapist can recognize and normalize the
participants emotions and movement patterns, capturing and preserving the individual needs
within the group, at the same time as having an overview of the group and the social
interactions within it.
Teaching recovery techniques (TRT) is a group-based mental health intervention developed by
the Children and war foundation to use on subjects exposed to war or nature catastrophes
previously used in the Centre for migration and health at the municipality of Bergen. This
treatment addresses the three main trauma symptoms: intrusion, arousal and avoidance. Several
studies on the effect of TRT have been carried out with children surviving catastrophes and
adolescent asylum seekers in Europe, all showing significant reductions in established mental
health disorders (PTSD). Among adolescents in Palestine, TRT has recently been shown to
significantly reduce posttraumatic stress symptoms and was evaluated as a cost-effective
intervention. However, as far as theinvestigators know the effect on TRT has not previously
been studied in an adult population with post-traumatic symptoms.
Our hypotheses for the development of the interventions are the following: Among asylum
seekers and refugees resettled in Norway
- Pain disorders and post-traumatic symptoms often coexist and are related to each other
- Group physiotherapy treatment reduces pain levels
- Group physiotherapy treatment improves mental health
- Self-help groups using TRT improve mental health
- Self-help groups using TRT reduce pain levels
- Social and contextual factors and previous migration experiences are related to the
effect of treatment
Aims of the study
Among resettled asylum seekers and refugees, the primary aim is to separately study in a
quantitative way the effect on both physical and mental health of two different
interventions:
1. Physiotherapy activity and awareness intervention (PAAI) for participants with pain
disorders
2. TRT 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.
Interventions Two different interventions have been developed in close collaboration with all
collaborating parts and based in both theory and experience.
1. Physiotherapy activity and awareness intervention: PAAI The physiotherapy treatment will
be held in groups based on principles from the Norwegian psychomotor physiotherapy and
general physiotherapy exercises.
2. Psychological intervention: Teaching recovery techniques (TRT) The mental health
self-help groups are based on the manual TRT developed by Children and war foundation
based on Trauma focused cognitive behavioural Therapy. Each group will be conducted by
two members of the team. An effort has been done to certify collaborating interpreters
and the investigators will try to use the same interpreters for a given group. TRT is
designed to teach children in a step-by-step practical way to develop some skills and
techniques helpful in coping with the psychological effects of war and violence.
Study design Our study is designed as a randomised trial comparing the intervention with a
control arm. The control arm will be offered the same intervention after a time lag enabling
comparison (waiting-list-control trial). This design enables assessment of the intervention
and has practical advantages in implementation. The same design will be used for both the
PAAI and the TRT intervention. Participants with predominantly pain symptoms will be invited
to the PAAI intervention and participants with predominantly post-traumatic symptoms will be
invited to the TRT intervention. Participants scoring high on both symptoms will be offered
the intervention for which they score highest in the respective symptoms scales. Once
assessed for eligibility and given informed consent as explained above, randomisation of each
participant to the appropriate trial will be conducted (individualised 1:1 randomisation into
groups). Participants will be randomised to the immediate intervention group (IIG) or to a
waiting list control group (WLG). The WLG will receive usual care during the first 7/8 weeks,
depending on the intervention, at which point they will cross over to the intervention arm
and receive the intervention for 7/8 weeks. Both groups will be reassessed 12 weeks after the
intervention.
In addition to the assessment of the effect of the intervention through quantitative methods
as described under, an embedded qualitative process evaluation will be organised to learn how
the interventions are perceived by the target group and the therapists, and receive input to
make the necessary adjustments.
