The effectiveness of a Supported Self-management task-shifting intervention for adult depression in Vietnam communities: study protocol for a randomized controlled trial

Abstract

BackgroundDepressive disorders are one of the leading causes of disease and disability worldwide. In Vietnam, although epidemiological evidence suggests that depression rates are on par with global averages, services for depression are very limited. In a feasibility study that was implemented from 2013 to 2015, we found that a Supported Self-management (SSM) intervention showed promising results for adults with depression in the community in Vietnam.This paper describes the Mental Health in Adults and Children: Frugal Innovations (MAC-FI) trial protocol that will assess the effectiveness of the SSM intervention, delivered by primary care and social workers, to community-based populations of adults with depression in eight Vietnamese provinces.Methods/designThe MAC-FI program will be assessed using a stepped-wedge, randomized controlled trial. Study participants are adults aged 18 years and over in eight provinces of Vietnam. Study participants will be screened at primary care centres and in the community by health and social workers using the Self-reporting Questionnaire-20 (SRQ-20). Patients scoring >7, indicating depression caseness, will be invited to participate in the study in either the SSM intervention group or the enhanced treatment as usual control group. Recruited participants will be further assessed using the World Health Organization’s Disability Assessment Scale (WHODAS 2.0) and the Cut-down, Annoyed, Guilty, Eye-opener (CAGE) Questionnaire for alcohol misuse. Intervention-group participants will receive the SSM intervention, delivered with the support of a social worker or social collaborator, for a period of 2 months. Control- group participants will receive treatment as usual and a leaflet with information about depression. SRQ-20, WHODAS 2.0 and CAGE scores will be taken by blinded outcome assessors at baseline, after 1 month and after 2 months. The primary analysis method will be intention-to-treat.DiscussionThis study has the potential to add to the knowledge base about the effectiveness of a SSM intervention for adult depression that has been validated for the Vietnamese context. This trial will also contribute to the growing body of evidence about the effectiveness of low-cost, task-shifting interventions for use in low-resource settings, where specialist mental health services are often limited.Trial registrationRetrospectively registered at ClinicalTrials.gov, identifier: NCT03001063. Registered on 20 December 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-1924-5) contains supplementary material, which is available to authorized users.

Is supported self-management for depression effective for adults in community-based settings in Vietnam?: a modified stepped-wedge cluster randomized controlled trial

“…The sample size required for this trial was calculated [9]. In summary, it was assumed that each commune would recruit an average of eight participants with a follow-up period of 2 months after baseline and an effect size of 0.4 for the SRQ-20, where the effect size was estimated as the ratio of the minimum clinically important difference divided by the standard deviation at baseline across all study participants.…”

“…This primary analysis uses Period 1 data only and has the advantage of being unaffected by the higher amounts of missing data in Period 2. The analysis was based on the individual patient-level data, rather than on the commune-level summarized data as tentatively suggested in Murphy et al 2017 [9]. The individual-level analysis had the advantages of exploiting the full richness of the individual-level data and utilizing the individuallevel covariates and observed outcome values to account for missing outcome values.…”

“…Uncertainty regarding the flow of funds from government to the funding agency meant we were concerned with the feasibility of implementing Period 2 of the study. Therefore the study was powered to have the primary analysis to estimate intervention effects using Period 1 only [9], which is a simpler clustered randomized clinical trial (RCT) design. We conducted the secondary analysis that included the outcome data from Period 2 and additionally used the comparison between Period 1 and Period 2 for estimating SSM intervention effects.…”

“…Figure 2 displays the CONSORT flow diagram of the trial. Recruitment procedures have been described in more detail elsewhere [9]. Adults 18 years and older were recruited in primary care and community-based settings in the study communes.…”

“…Clinical significance of SRQ-20 change scores is not well-established, and evidence regarding interpretation of clinical significance using the SRQ-20 is extremely limited. This study was powered for medium clinical significance with effect size at 0.5, with > 0.8 considered a large effect size [9]. The analysis shows an effect size of − 1.03.…”