ACTRN12621000189820.

Study name	Randomised controlled trial of a stepped care intervention comprising Self‐Help Plus and Problem Management Plus versus Self‐Help Plus on anxiety and depression in Jordanians experiencing distress
Methods	Study design: RCT Country: Jordan
Participants	Participants will be adults indicating moderate distress Inclusion criteria:  a. Syrian refugees; b. Aged at least 18 years; c. K6 score of at least 6; and d. WHODAS score of at least 16. Exclusion criteria: a. imminent plans of suicide; b. psychotic disorders; c. severe cognitive impairment; d. identification of risk of the person’s safety (e.g. partner violence); and e. plans to return to Syria in next 12 months. Stated purpose: test how a stepped care programme can (a) provide scalable programs to all people who require assistance, and (b) offer much‐needed programmes to those who do not benefit from initial intervention
Interventions	Intervention: Stepped care (SH+ and PM+ or monitoring) Therapy commences with Self‐Help Plus (SH+), which involves once‐weekly 120‐minute sessions delivered by a facilitator over 5 weeks, delivered and based on audiobooks to groups of 20‐30 people at a time. Participants who are not distressed following SH+ will continue to be assessed but will receive no further assistance. Participants who are distressed at the end of SH+ will be provided with Problem Management Plus (PM+). PM+ is a programme developed by the World Health Organization. PM+ involves once‐weekly 120‐minute sessions delivered by a facilitator over 5 weeks to groups of 8‐10 people at a time. SH+ will teach participants strategies in mindfulness and acceptance strategies. Intervention timeline: 10 weeks of intervention (5 weeks of SH+ and 5 weeks of PM+ or 5 weeks of SH+ and 5 weeks of monitoring). Control: Single intervention (SH+ and monitoring). The Single Intervention commences with Self‐Help Plus (SH+), which involves once‐weekly 120‐minute sessions delivered by a facilitator over 5 weeks, delivered and based on audiobooks to groups of 20‐30 people at a time. Timeline: 5 weeks of SH+ and 5 weeks of monitoring
Outcomes	Participants'outcomes of interest for this review Mental health symptoms/anxiety – Hopkins Symptom Checklist (HSCL) Mental health symptoms/depression – Hopkins Symptom Checklist (HSCL) Psychological functioning and impairment – WHO Disability Assessment Scale Mental health symptoms/distress/PTSD – PTSD Checklist Economic outcomes Nil Time points: baseline, post‐intervention (specific time if provided)
Starting date	1 April 2021 (first participant enrolment)
Contact information	Prof Richard Bryant, r.bryant@unsw.edu.au
Notes	Source of funding: ELRHA Prospective trial registration number: ACTRN12621000189820