Effectiveness and cost-effectiveness of a Stepped care framework for psychological interventions for reducing common mental health symptoms in Jordan: a single-blind randomised clinical trial

Abstract

Despite most of the world's population having poor access to mental health services, scalable interventions delivered by trained non-specialists are implemented widely in low-income and middle-income countries (LMICs). Many people do not respond to these interventions, which has led to initiatives to adopt stepped care frameworks that provide people who do not respond to initial interventions with more intensive interventions. However, to date, the efficacy and cost-effectiveness of stepped care frameworks for scalable interventions have not been evaluated in LMICs. This trial aims to evaluate effectiveness and cost-effectiveness of psychological stepped care for distressed adults in an LMIC. Methods We did a single-blind, parallel, randomised controlled trial in Jordan with psychologically distressed adults who were randomly assigned (1:1) to a single intervention or stepped care model. Participants were required to be aged 18 years and older, Jordanians or refugees residing in Jordan, and have scores of at least 20 on the Kessler Distress Scale. Exclusion criteria were imminent suicide risk, psychotic disorder, severe cognitive impairment, risk to the person's safety, plan to return to Syria in the next 12 months, or no telephone access. Computerised software was used for randomisation to generate random number sequences in blocks of four, stratified according to nationality status by personnel independent of the trial. Assessors were masked to intervention condition. All participants received WHO's Doing What Matters in Time of Stress (DWM) programme, which comprised a five-session guided self-help programme. For participants who reported psychological distress after DWM, those in the single intervention group received enhanced usual care, whereas those in the stepped care group received WHO's Problem Management Plus, a five-session group psychological intervention. The primary outcome was between treatment group change in anxiety and depression severity assessed at 3 months after treatment (primary outcome timepoint) based on intention-to-treat analysis. Cost-effectiveness was also assessed. The trial was prospectively registered on the Australian New Zealand Clinical Trials Registry, ACTRN12621000189820, and is completed. Findings Between June 8 and Oct 8, 2023, 1233 individuals were screened for study inclusion and 432 were excluded (371 due to minimal distress, 30 due to a suicide risk, and 31 decided not to proceed), resulting in 801 participants being enrolled into the study. 400 participants were randomly assigned to the stepped care group and 401 were randomly assigned to the single intervention group. 753 participants were female (94%), 48 (6%) were male, and the mean age was 40·7 years (SD 11·1). At the 3-month assessment, participants enrolled in stepped care reported greater reduction of anxiety (mean difference 1·9 [95% CI 0·6–3·2; p=0·0030; effect size 0·3 [95% CI 0·1–0·5]) and depression (mean difference 2·9 [0·9–5·0]; p=0·0050; effect size 0·3 [0·1–0·5]) than participants in the single intervention group. The incremental cost per quality-adjusted life-year gained for stepped care (in international dollars [INT$]) would be INT$23 641 and has a 76% likelihood of being cost-effective at a threshold of INT$31 879 in Jordan. Interpretation Stepped care of WHO's evidence-based scalable interventions can provide greater benefits in reducing common mental disorders compared with a single intervention. Although a more resource-demanding treatment strategy, stepped care can be cost-effective in terms of its capacity for relatively greater improvements in mental health in LMICs. Funding Elrha through the Research for Health in Humanitarian Crises (R2HC) programme. Translation For the Arabic translation of the abstract see Supplementary Materials section.