Evaluating a stepped care model of psychological support for adults affected by adversity: study protocol for a randomised controlled trial in Jordan.

BACKGROUND: The burden of common mental disorders in low and middle-income countries (LMICs) is growing with little known about how to allocate limited resources to reach the greatest number of people undergoing instances of significant psychological distress. We present a study protocol for a multicentre, parallel-group, superiority, randomised controlled trial. METHODS AND ANALYSIS: Adults with significant psychological distress (K10 score ≥20) will be randomised to receive a stepped care programme involving a self-guided course (Doing What Matters) followed by a more intensive group programme (Problem Management Plus) or the self-guided course alone, both of which will take place in addition to enhanced treatment as usual comprising of a follow-up referral session to available services within the community. We will include 800 participants. An intent-to-treat and completer analysis will explore the impact of the stepped model of care on anxiety and depression symptoms (as measured by the Hopkins Symptom Checklist; HSCL-25) at 24 weeks from baseline. Secondary outcomes include positive psychological well-being, agency, changes in patient-identified problems, quality of life and cost-effectiveness. Linear mixed models will be used to assess the differential impact of the conditions over time. Analyses will focus on the primary outcome (HSCL-25) and secondary outcomes (agency subscale, WHO Well-Being Index, WHO Disability Assessment Schedule V.2.0, EQ-5D, Psychological Outcomes Profiles Scale) for both conditions, with the main outcome time point being the 3-month follow-up, relative to baseline. ETHICS AND DISSEMINATION: This will be the first randomised controlled trial to assess the benefits of a stepped model of care to addressing psychological distress in a LMIC setting. Results will provide important insights for managing limited resources to mental healthcare in these settings and will be accordingly disseminated to service providers and organisations via professional training and meetings, and via publication in relevant journals and conference presentations. We will also present these findings to the Jordanian Ministry of Health, where this institute will guide us on the most appropriate format for communication of findings, including written reports, verbal presentations and/or brochures. Ethical approval was obtained from the University of Jordan School of Nursing Research Ethics Committee (number: PF.22.10). TRIAL REGISTRATION NUMBER: ACTRN12621000189820p; Australian New Zealand Clinical Trials Registry.

Correction to: Early Adolescent Skills for Emotions (EASE) intervention for the treatment of psychological distress in adolescents: study protocol for randomised controlled trials in Lebanon and Jordan.

Following publication of the original article [1], we have been notified that Figure 1 was published with the track changes. In this Correction the incorrect and correct Fig. 1 are shown.

Early Adolescent Skills for Emotions (EASE) intervention for the treatment of psychological distress in adolescents: study protocol for randomised controlled trials in Lebanon and Jordan.

BACKGROUND: There are significant barriers to providing accessible, quality mental health care for young adolescents affected by adversity. In an attempt to overcome this, the World Health Organization (WHO) has developed the Early Adolescent Skills for Emotions (EASE) psychological intervention for young adolescents with internalising problems. EASE is group-based (seven sessions for adolescents, three sessions for their caregivers) and can be delivered by non-specialist providers. This paper outlines the study protocols for two trials of EASE in the Middle East - one in Lebanon and one in Jordan. METHODS: We will conduct two, single-blind, two-arm, individually randomised group treatment trials in Lebanon and Jordan, with at least 445 young adolescents per trial. Adolescents will be screened eligible for the trial if they demonstrate levels of psychological distress indicative of internalizing problems requiring treatment. Participants will be randomly assigned to receive the EASE intervention, or enhanced usual care (one home-visit psychoeducation session). The primary outcome is reduction in overall child-reported psychological distress over time, with 3 months post-treatment as the primary end point. Secondary child-reported outcomes include post-traumatic stress symptoms, depression symptoms, daily functioning, and wellbeing. Secondary caregiver-reported outcomes include parenting style, overall child distress, and caregiver psychological distress. Coping strategy use will be explored as a mediator of treatment effects in Lebanon, and relevant moderators of treatment effects will be explored. DISCUSSION: These trials will provide the first assessments of the effectiveness of the EASE intervention for use in the Middle East, with important implications for the use of low-intensity, non-specialist interventions for this age range. TRIAL REGISTRATION: Lebanon: ISRCTN75375136 . Registered on 11 March 2019. Jordan: Australia New Zealand Clinical Trials Registry, ACTRN12619000341123. Registered on 5 March 2019 ( https://www.anzctr.org.au/ ).