Stepped-care programme of brief psychological interventions for adults affected by adversity in Jordan: lessons from a pilot randomised controlled trial.

Abstract

To pilot test a stepped care intervention and examine trial procedures in advance of a definitive randomised controlled trial (RCT). We aimed to evaluate safety, acceptability and adherence to interventions.<b>Design</b>A two-arm, single-blind, parallel, pilot RCT.<b>Setting</b>Multicentre primary healthcare settings. Adults with significant psychological distress (K10 (Kessler Psychological Distress Scale) score ≥20) were recruited in Jordan between September 2022 and February 2023. Participants were randomised to one of two arms. The intervention arm received a stepped care programme consisting of a guided self-help programme (Doing What Matters; DWM), followed by a more intensive group programme (group Problem Management Plus; gPM+). The control arm received a guided self-help programme alone. Both intervention arms also received Enhanced Treatment as Usual that comprised referral to available community support services. A mixed methods approach was used to examine trial procedures in preparation for a definitive RCT, evaluate safety, acceptability and adherence to interventions and examine the pattern of quantitative outcomes. The primary clinical outcome was assessor-reported depression and anxiety symptoms (Hopkins Symptom Checklist-25) at week 12. 145 distressed adults (meeting Kessler Distress Score-10 score of ≥20) were randomised to either the stepped care or the single intervention arm (86% female) on a 1:1 allocation basis. DWM was delivered over 5 weeks by trained non-specialist helpers, where participants attended on average 2.6 support calls. Those randomised to gPM+attended on average 3.3 sessions. The study demonstrated feasibility and acceptability for DWM and gPM+interventions as delivered by trained non-specialists. Although the trial was not powered to detect clinical effectiveness, the stepped care arm relative to the single intervention arm demonstrated significantly lower depression symptoms immediately after and at 3 months following intervention delivery. The study and trial procedures were acceptable to participants, non-specialists and programme staff and demonstrated feasibility of implementing such a framework in Jordan. Findings from this trial informed a fully powered definitive RCT seeking to evaluate the clinical and cost-effectiveness of a stepped model of care in Jordan. ACTRN12621000189820p.