None listed
Conditions
Brief summary
The number of people forcibly displaced worldwide is ~68 million. Refugees report rates of posttraumatic stress disorder (PTSD) that are over five times that seen in the general Australian community. PTSD in refugees is associated with elevated depression, suicidality and functional impairment, however many do not benefit from evidence-based interventions for this disorder. Thus, there is an urgent need to improve existing psychological interventions for PTSD in individuals with a refugee background, by directly targeting the specific mental health needs of this vulnerable population. Narrative Exposure Therapy (NET) is currently the leading evidence-based trauma-focused intervention for PTSD relevant to the refugee context. Previous research suggests that emotion regulation difficulties are highly prominent in refugees, and demonstrate a strong association with PTSD. Skills Training in Affective and Interpersonal Regulation (STAIR) is a treatment that comprises a skills training phase in which patients learn skills related to emotional and interpersonal regulation, prior to engaging in trauma-focused therapy for PTSD. In this study, we investigate the efficacy of a phase-based treatment for PTSD (STAIR-Refugees [STAIR-R] + NET) that has been specifically adapted for refugees. Participants will complete assessment and treatment sessions in either a face to face setting or online using videoconferencing software. Eligible participants will be randomised to one of two parallel treatment arms. In Arm 1, the first phase will comprise 6 sessions of STAIR-R. Participants then complete phase 2, which will comprise 7 NET sessions. In Arm 2, the first phase will comprise 6 supportive problem-solving (SP) treatment sessions, which have been developed specifically for refugees. Participants then complete phase 2, which will comprise 7 NET sessions. We predict that participants in the STAIR-R +NET condition will show greater improvements in PTSD symptoms compared to those in the SP + NET condition. Participants will complete assessments at baseline, after completing Phase 1, post-treatment (one week after completing NET session 7), 3 months follow-up (3 months following treatment completion), and at one year follow-up (12 months after treatment completion). The primary outcome is change in PTSD symptom severity. There is also a range of secondary outcomes that will be examined including symptoms of depression, anxiety, emotion regulation, and quality of life.
Interventions
This study is a randomised clinical trial with two phases (parallel design). There are 2 active arms in this study: Arm 1- Skills Training in Affective and Interpersonal Regulation (STAIR) (phase 1) and Narrative Exposure Therapy (phase 2); Arm 2- supportive problem-solving (control condition; phase 1) and Narrative Exposure Therapy (phase 2).
In the STAIR treatment sessions, patients learn skills related to emotion regulation, prior to engaging in exposure therapy for PTSD (Cloitre et al., 200
This study is a randomised clinical trial with two phases (parallel design). There are 2 active arms in this study: Arm 1- Skills Training in Affective and Interpersonal Regulation (STAIR) (phase 1) and Narrative Exposure Therapy (phase 2); Arm 2- supportive problem-solving (control condition; phase 1) and Narrative Exposure Therapy (phase 2). In the STAIR treatment sessions, patients learn skills related to emotion regulation, prior to engaging in exposure therapy for PTSD (Cloitre et al., 2002). STAIR sessions have been specifically adapted to suit the refugee context by the study team. NET is currently the leading evidence-based trauma-focused intervention for PTSD relevant to the refugee context (Schauer, Neuner, Elbert, 2011). Both treatment arms will participate in 13 x 90 minute sessions, scheduled at once per week over 13 weeks. The first 6 sessions (phase 1) will comprise either STAIR or supportive problem-solving (SP) treatment sessions and the following 7 will be NET sessions (phase 2). All treatment sessions will be delivered individually in either a face-to-face format held at the Westmead Institute of Medical Research or via the internet using videoconferencing software on an applicable device (e.g., tablet, computer, smartphone). The treatment manuals for STAIR and NET have been adapted to suit refugees. The treatment manual for the control condition has been developed specifically for this study and involve supportive problem-solving techniques. Clinical psychologists trained in the delivery of STAIR, supportive problem-solving, and NET will facilitate the interventions. Trial therapists will undergo specific training in delivering all treatment sessions including the use of a protocol based treatment manual. The following protocols will be followed to ensure close therapeutic compliance with the treatment manuals used for both the intervention and control conditions: (i) therapists will receive regular clinical supervision; (ii) participant attendance will be recorded by the clinician as part of routine care; (iii) the treatment manuals will be used in all treatment sessions; (iv) with participant consent all treatment sessions will be video recorded and 15% will be randomly selected and rated for therapist adherence to the manual.
Sponsors
Professor Angela Nickerson
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria (i) Aged over 18 years old (ii) A refugee or asylum-seeker background (iii) Fluent and literate in Arabic, Farsi or Dari (iv) Meet criteria for PTSD diagnosis (according to DSM-5) (v) If on concurrent pharmacological treatment they will be on a stable dose for one month prior to completing their initial assessment
Exclusion criteria
Exclusion criteria: (i) Individuals experiencing active suicidality (intent and/or a previous suicide attempt in the past three months) (ii) Active psychosis or alcohol/substance dependence (ii) Moderate to severe traumatic brain injury
Outcome results
None listed