The effectiveness and cost-effectiveness of the peer-delivered Thinking Healthy Programme for perinatal depression in Pakistan and India: the SHARE study protocol for randomised controlled trials

Sikander, Siham; Lazarus, Anisha; Bangash, Omer; Fuhr, Daniela C.; Weobong, Benedict; Krishna, Revathi N.; Ahmad, Irshad; Weiss, Helen A.; Price, LeShawndra N.; Rahman, Atıf; Patel, Vikram

doi:10.1186/s13063-015-1063-9

Cited by 72 publications

(77 citation statements)

References 44 publications

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“…The first two studies, based in India and Pakistan,38 and Zimbabwe,39 are examples of next steps taken in the field to conduct robust, randomised controlled trials of the low-intensity psychosocial interventions advocated by the mhGAP-IG alongside consideration of pharmacotherapy. The use of the mhGAP-IG for controlled implementation of ‘enhanced treatment as usual’ represents a valuable opportunity to acquire rigorous evidence of its utility in a range of LMICs.…”

Section: Resultsmentioning

confidence: 99%

WHO Mental Health Gap Action Programme (mhGAP) Intervention Guide: a systematic review of evidence from low and middle-income countries

Keynejad

Dua

Barbui

et al. 2017

Evid Based Mental Health

210

206

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Data were extracted from included papers, but heterogeneity prevented meta-analysis. Findings:We conducted a systematic review of evidence to date, of mhGAP-IG implementation and evaluation in LMICs. 33 included studies reported 15 training courses, nine clinical implementations, three country contextualisations, three economic models, two uses as control interventions and one use to develop a rating scale. Our review identified the importance of qualitative reports of contextual challenges in the field, alongside detailed protocols, qualitative studies and randomised controlled trials. Conclusions:The mhGAP-IG literature is substantial, relative to other published evaluations of clinical practice guidelines: an important contribution to a neglected field.3

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Section: Resultsmentioning

confidence: 99%

WHO Mental Health Gap Action Programme (mhGAP) Intervention Guide: a systematic review of evidence from low and middle-income countries

Keynejad

Dua

Barbui

et al. 2017

Evid Based Mental Health

210

206

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“…The protocol for the THPP trial has been published [14]. Similar in content to the THP, the peer-delivered version is simplified with additional strategies added for ease of implementation by peers.…”

Section: Methodsmentioning

confidence: 99%

“…For the THPP, peers were trained in a 5-day classroom-based workshop, followed by a 2-month internship during which they practiced the content of the THPP on nontrial participants [14]. For THPP+, peers will receive an additional 2 days of classroom training after their last session (during the fifth postnatal month) of the THPP to cover the additional content.…”

Section: Methodsmentioning

confidence: 99%

“…In response to this need, the Thinking Health Program Peer-delivered (THPP) was developed by adapting the THP to be delivered primarily by peers who operate within the existing CHW system. An ongoing study, the THPP-Pakistan trial [14], seeks to evaluate THPP for 6 postnatal months.…”

Section: Introductionmentioning

confidence: 99%

“…This manuscript complements and extends the THPP trial protocol [14]. To ensure that the current protocol is able to stand alone, we present the necessary key features of the THPP design and the ways in which the THPP+ trial builds on, and is different from, the ongoing THPP trial in Pakistan.…”

Section: Introductionmentioning

confidence: 99%

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The effectiveness of the peer delivered Thinking Healthy Plus (THPP+) Programme for maternal depression and child socio-emotional development in Pakistan: study protocol for a three-year cluster randomized controlled trial

Turner

Sikander

Bangash

et al. 2016

Trials

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BackgroundThe negative effects of perinatal depression on the mother and child start early and persist throughout the lifecourse (Lancet 369(9556):145–57, 2007; Am J Psychiatry 159(1):43-7, 2002; Arch Dis Child 77(2):99–101, 1997; J Pak Med Assoc 60(4):329; J Psychosoma Res 49(3):207–16, 2000; Clin Child Fam Psychol Rev 14(1):1–27, 2011). Given that 10–35 % of children worldwide are exposed to perinatal depression in their first year of life (Int Rev Psychiatry 8(1):37–54, 1996), mitigating this intergenerational risk is a global public health priority (Perspect Public Health 129(5):221–7, 2009; Trop Med Int Health 13(4):579–83, 2008; Br Med Bull 101(1):57–79, 2012). However, it is not clear whether intervention with depressed women can have long-term benefits for the mother and/or her child. We describe a study of the effectiveness of a peer-delivered depression intervention delivered through 36 postnatal months, the Thinking Healthy Program Peer-delivered PLUS (THPP+) for women and their children in rural Pakistan.Methods/designThe THPP+ study aims are: (1) to evaluate the effects of an extended 36-month perinatal depression intervention on maternal and index child outcomes using a cluster randomized controlled trial (c-RCT) and (2) to determine whether outcomes among index children of perinatally depressed women in the intervention arm converge with those of index children born to perinatally nondepressed women. The trial is designed to recruit 560 pregnant women who screened positive for perinatal depression (PHQ-9 score ≥10) from 40 village clusters, of which 20 receive the THPP+ intervention. An additional reference group consists of 560 perinatally nondepressed women from the same 40 clusters as the THPP+ trial. The women in the nondepressed group are not targeted to receive the THPP+ intervention; but, by recruiting pregnant women from both intervention and control clusters, we are able to evaluate any carryover effects of the THPP+ intervention on the women and their children. Perinatally depressed women in the THPP+ intervention arm receive bimonthly group-based sessions. Primary outcomes are 3-year maternal depression and 3-year child development indicators. Analyses are intention-to-treat and account for the clustered design.DiscussionThis trial, together with the reference group, has the potential to further our understanding of the early developmental lifecourse of children of both perinatally depressed and perinatally nondepressed women in rural Pakistan and to determine whether intervening with women’s depression in the perinatal period can mitigate the negative effects of maternal depression on 36-month child development.Trial registrationTHPP-P ClinicalTrials.gov Identifier: NCT02111915 (registered on 9 April 2014).THPP+ ClinicalTrials.gov Identifier: NCT02658994 (registered on 21 January 2016).Sponsor: Human Development Research Foundation (HDRF).Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1530-y) contains supplementary material, which is availabl...

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Primary-level worker interventions for the care of people living with mental disorders and distress in low- and middle-income countries

Ginneken

Chin

Lim

et al. 2021

Cochrane Database of Systematic Reviews

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Background Community‐based primary‐level workers (PWs) are an important strategy for addressing gaps in mental health service delivery in low‐ and middle‐income countries. Objectives To evaluate the effectiveness of PW‐led treatments for persons with mental health symptoms in LMICs, compared to usual care. Search methods MEDLINE, Embase, CENTRAL, ClinicalTrials.gov, ICTRP, reference lists (to 20 June 2019). Selection criteria Randomised trials of PW‐led or collaborative‐care interventions treating people with mental health symptoms or their carers in LMICs. PWs included: primary health professionals (PHPs), lay health workers (LHWs), community non‐health professionals (CPs). Data collection and analysis Seven conditions were identified apriori and analysed by disorder and PW examining recovery, prevalence, symptom change, quality‐of‐life (QOL), functioning, service use (SU), and adverse events (AEs). Risk ratios (RRs) were used for dichotomous outcomes; mean difference (MDs), standardised mean differences (SMDs), or mean change differences (MCDs) for continuous outcomes. For SMDs, 0.20 to 0.49 represented small, 0.50 to 0.79 moderate, and ≥0.80 large clinical effects. Analysis timepoints: T1 (<1 month), T2 (1‐6 months), T3 ( >6 months) post‐intervention. Main results Description of studies 95 trials (72 new since 2013) from 30 LMICs (25 trials from 13 LICs). Risk of bias Most common: detection bias, attrition bias (efficacy), insufficient protection against contamination. Intervention effects *Unless indicated, comparisons were usual care at T2. “Probably”, “may”, or “uncertain” indicates "moderate", "low," or "very low" certainty evidence. Adults with common mental disorders (CMDs) LHW‐led interventions a. may increase recovery (2 trials, 308 participants; RR 1.29, 95%CI 1.06 to 1.56); b. may reduce prevalence (2 trials, 479 participants; RR 0.42, 95%CI 0.18 to 0.96); c. may reduce symptoms (4 trials, 798 participants; SMD ‐0.59, 95%CI ‐1.01 to ‐0.16); d. may improve QOL (1 trial, 521 participants; SMD 0.51, 95%CI 0.34 to 0.69); e. may slightly reduce functional impairment (3 trials, 1399 participants; SMD ‐0.47, 95%CI ‐0.8 to ‐0.15); f. may reduce AEs (risk of suicide ideation/attempts); g. may have uncertain effects on SU. Collaborative‐care a. may increase recovery (5 trials, 804 participants; RR 2.26, 95%CI 1.50 to 3.43); b. may reduce prevalence although the actual effect range indicates it may have little‐or‐no effect (2 trials, 2820 participants; RR 0.57, 95%CI 0.32 to 1.01); c. may slightly red...

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The effectiveness and cost-effectiveness of the peer-delivered Thinking Healthy Programme for perinatal depression in Pakistan and India: the SHARE study protocol for randomised controlled trials

Cited by 72 publications

References 44 publications

WHO Mental Health Gap Action Programme (mhGAP) Intervention Guide: a systematic review of evidence from low and middle-income countries

WHO Mental Health Gap Action Programme (mhGAP) Intervention Guide: a systematic review of evidence from low and middle-income countries

The effectiveness of the peer delivered Thinking Healthy Plus (THPP+) Programme for maternal depression and child socio-emotional development in Pakistan: study protocol for a three-year cluster randomized controlled trial

Primary-level worker interventions for the care of people living with mental disorders and distress in low- and middle-income countries

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