Primary Objective:To evaluate feasibility, acceptability, effectiveness and cost-effectiveness of the culturally adapted PM+ intervention forSyrian refugees in The Netherlands.Secondary Objective(s):1. To translate and (culturally) adapt PM+ for use…
ID
Source
Brief title
Condition
- Other condition
- Mood disorders and disturbances NEC
Synonym
Health condition
Psychological symptoms of anxiety, (posttraumatic) stress and depression, anger, hair biomarkers
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter will be the decrease in psychological distress from
baseline to three-month follow-up, measured through the Hopkins Symptoms
Checklist (HSCL-25), a self-report measure for symptoms of psychological
distress. We expect a difference of Cohen*s d effect size of .4 between the PM+
group and controls.
Secondary outcome
Secondary parameters include functional impairment (WHODAS 2.0), posttraumatic
stress reactions (PCL-5), self-identified problems (PSYCHLOPS), cost of care
(CSRI schedule), anger (STAS-T), and hair biomarkers
Background summary
The current refugee crisis across the Middle East and Europe has large effects
on individual refugees* psychological wellbeing, as well as on the healthcare
systems of countries housing refugees. The WHO have developed Problem
Management Plus (PM+), a brief (five-sessions), low-intensity psychological
intervention, delivered by paraprofessionals, that addresses common mental
disorders in people in communities affected by adversity.
Study objective
Primary Objective:
To evaluate feasibility, acceptability, effectiveness and cost-effectiveness of
the culturally adapted PM+ intervention for
Syrian refugees in The Netherlands.
Secondary Objective(s):
1. To translate and (culturally) adapt PM+ for use among Syrian refugees in The
Netherlands (Study Phase 1, described in a separate protocol)
2. To obtain estimates of drop-out rates to inform a full-scale, definitive
randomized controlled trial (Study Phase 2)
3. To understand the perceptions of key stakeholders with regards to PM+
intervention (Study Phases 3A and 5B)
4. To identify barriers and facilitators to accessing mental health care for
Syrian refugees (Study Phase 3B)
5. To test effectiveness and cost-effectiveness of the PM+ intervention (Study
Phase 4)
Study design
Study Phase 1, 3 and 5: Qualitative study
Study Phase 2: Exploratory, single-blind randomized controlled trial (RCT)
Study Phase 4: Definitive single-blind RCT
Intervention
Participants in the treatment group will receive five sessions of Problem
Management Plus (PM+), and treatment as usual (TAU). PM+ is an evidence-based,
low-intensity, psychological intervention and will be delivered by trained
peer-refugees. The control group will receive TAU only.
Study burden and risks
Interested participants will be invited for a total of four interviews over a
period of one year. The interviews include questionnaires on daily functioning
and psychological complaints, adverse experiences, daily hassles and cost of
care. The interview will take approximately 1.5hrs. Participants in the
treatment group will receive five sessions PM+, which will be audiotaped for
the purpose of supervision and monitoring.
Van der Boechorststraat 7
Amsterdam 1081 BT
NL
Van der Boechorststraat 7
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
(Phase 2 and 4B, Exploratory randomized controlled trial (RCT) and Definite RCT)
- 18 years or above
- refugee
- Arabic-speaking
- Elevated levels of psychological distress (K10 >15.9) and reduced
psychosocial functioning (WHODAS 2.0 >16)
Exclusion criteria
(for participants in phase 2 and 4B)
- Acute medical conditions
- Imminent suicide risk or with expressed acute needs/protection risks (e.g., a
young woman who expresses that she is at acute risk of being assaulted or
killed)
- Severe mental disorder (psychotic disorders, substance-dependence)
- Severe cognitive impairment (e.g., severe intellectual disability or dementia)
- Currently enrolled in a specialized psychological treatment program (e.g.,
EMDR, CBT)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL61361.029.17 |