Dataset Information

The Effect of Group Support Psychotherapy Delivered by Trained Lay Health Workers for Depression Treatment Among People with HIV in Uganda: Protocol of a Pragmatic, Cluster Randomized Trial.

ABSTRACT:

Background

There is limited information on the effectiveness of task shifting of mental health services in populations with HIV.

Objective

This trial aims to evaluate the effectiveness of group support psychotherapy delivered by trained lay health workers to persons living with HIV (PLWH) with depression in primary care.

Methods

Thirty eligible primary care health centers across three districts were randomly allocated to have their lay health workers trained to deliver group support psychotherapy (intervention arm) or group HIV education and treatment as usual (control arm) to PLWH with depression. Treated PLWH will be evaluated at baseline, after the end of treatment, and at 6-month intervals thereafter for 2 years. Primary outcomes will be the difference in follow-up proportions of participants with Mini International Neuropsychiatric Interview criteria for major depression and difference in follow-up function scores of participants in the intervention and control arms 6 months after the end of treatment. Secondary outcomes will include measures of self-esteem, posttraumatic stress symptoms, social support, stigma, adherence to antiretroviral therapy, viral load, and number of disability days, asset possession indices, and cost-effectiveness data. Primary and secondary outcomes as well as subgroup analyses will be conducted at the individual level using multilevel random effects regression analyses adjusting for clustering in health centers. A process evaluation using mixed methods to assess acceptability, feasibility, fidelity, causal mediating processes, and contextual influences in the trial will be conducted.

Results

The trial has been approved by the Makerere College of Health Sciences School of Health Sciences Research Ethics Committee, the AIDS Support Organization, and the Uganda National Council of Science and Technology. A data and safety monitoring board has been put in place to monitor trial progress. A total of 1140 persons living with HIV have been recruited to the trial. An analysis of baseline and 6-month data is in progress. The results of this trial will not only be presented at national and international conferences but also submitted for publication in peer-reviewed journals and as a report to the funding agencies.

Conclusions

This cluster randomized trial will provide critical evidence to support culturally sensitive group-based psychotherapy for depression treatment in sub-Saharan Africa. Process evaluation outcomes will provide contextual information that health care and public health stakeholders can use to guide implementation decisions for their particular setting.

Trial registration

Pan African Clinical Trials Registry (PACTR): 201608001738234; http://www.pactr.org/ATMWeb/ appmanager/atm/atmregistry?dar=true&tNo=PACTR201608001738234 (Archived by WebCite at http://www.webcitation.org/ 6vUAgAQlj).

SUBMITTER: Nakimuli-Mpungu E

PROVIDER: S-EPMC5742658 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Publications

The Effect of Group Support Psychotherapy Delivered by Trained Lay Health Workers for Depression Treatment Among People with HIV in Uganda: Protocol of a Pragmatic, Cluster Randomized Trial.

Nakimuli-Mpungu Etheldreda E Musisi Seggane S Wamala Kizito K Okello James J Ndyanabangi Sheila S Mojtabai Ramin R Nachega Jean J Harari Ofir O Mills Edward E

JMIR research protocols 20171211 12

<h4>Background</h4>There is limited information on the effectiveness of task shifting of mental health services in populations with HIV.<h4>Objective</h4>This trial aims to evaluate the effectiveness of group support psychotherapy delivered by trained lay health workers to persons living with HIV (PLWH) with depression in primary care.<h4>Methods</h4>Thirty eligible primary care health centers across three districts were randomly allocated to have their lay health workers trained to deliver grou ...[more]

PMID: 29229589

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Project description:BackgroundA recently updated Cochrane systematic review on the effects of lay or community health workers (LHWs) in primary and community health care concluded that LHW interventions could lead to promising benefits in the promotion of childhood vaccination uptake. However, understanding of the costs and cost-effectiveness of involving LHWs in vaccination programmes remains poor. This paper reviews the costs and cost-effectiveness of vaccination programme interventions involving LHWs.MethodsArticles were retrieved if the title, keywords or abstract included terms related to 'lay health workers', 'vaccination' and 'economics'. Reference lists of studies assessed for inclusion were also searched and attempts were made to contact authors of all studies included in the Cochrane review. Studies were included after assessing eligibility of the full-text article. The included studies were then reviewed against a set of background and technical characteristics.ResultsOf the 2616 records identified, only three studies fully met the inclusion criteria, while an additional 11 were retained as they included some cost data. Methodologically, the studies were strong but did not adequately address affordability and sustainability and were also highly heterogeneous in terms of settings and LHW outcomes, limiting their comparability. There were insufficient data to allow any conclusions to be drawn regarding the cost-effectiveness of LHW interventions to promote vaccination uptake. Studies focused largely on health outcomes and did illustrate to some extent how the institutional characteristics of communities, such as governance and sources of financial support, influence sustainability.ConclusionThe included studies suggest that conventional economic evaluations, particularly cost-effectiveness analyses, generally focus too narrowly on health outcomes, especially in the context of vaccination promotion and delivery at the primary health care level by LHWs. Further studies on the costs and cost-effectiveness of vaccination programmes involving LHWs should be conducted, and these studies should adopt a broader and more holistic approach.

Project description:BackgroundLittle is known about how to scale up care for depression in settings where non-physician lay workers constitute the bulk of frontline providers. We aimed to compare a stepped-care intervention package for depression with usual care enhanced by use of the WHO Mental Health Gap Action Programme intervention guide (mhGAP-IG).MethodsWe did a cluster-randomised trial in primary care clinics in Ibadan, Nigeria. Eligible clinics were those with adequate staffing to provide various 24-h clinical services and with regular physician supervision. Clinics (clusters), anonymised and stratified by local government area, were randomly allocated (1:1) with a computer-generated random number sequence to one of two groups: an intervention group in which patients received a stepped-care intervention (eight sessions of individual problem-solving therapy, with an extra two to four sessions if needed) plus enhanced usual care, and a control group in which patients received enhanced usual care only. Patients from enrolled clinics could participate if they were aged 18 years or older, not pregnant, and had moderate to severe depression (scoring ≥11 on the nine-item patient health questionnaire [PHQ-9]). The primary outcome was the proportion of patients with remission of depression at 12 months (a score of ≤6 on the PHQ-9, with assessors masked to group allocation) in the intention-to-treat population. This trial is registered with the International Standard Randomised Controlled Trials Number registry (ISRCTN46754188) and is completed.Findings35 of 97 clinics approached were eligible and agreed to participate, of which 18 were allocated to the intervention group and 17 to the control group. 1178 patients (631 [54%] in the intervention group and 547 [46%] in the control group) were recruited between Dec 2, 2013, and June 29, 2015, among whom 976 (83%) were female and baseline mean PHQ-9 score was 13·7 (SD 2·6). Of the 562 (89%) patients in the intervention group and 473 (86%) in the control group who completed 12-month follow-up, similar proportions in each group had remission of depression (425 [76%] in the intervention group vs 366 [77%] in the control group; adjusted odds ratio 1·0 [95% CI 0·70-1·40]). At 12 months, 17 (3%) deaths, one (<1%) psychotic illness, and one (<1%) case of bipolar disorder in the intervention group, and 16 deaths (3%) and one (<1%) case of bipolar disorder in the control group were recorded. No adverse events were judged to be related to the study procedures.InterpretationFor patients with moderate to severe depression receiving care from non-physician primary health-care workers in Nigeria, a stepped-care, problem-solving intervention combined with enhanced usual care is similarly effective to enhanced usual care alone. Enhancing usual care with mhGAP-IG might provide simple and affordable approach to scaling up depression care in sub-Saharan Africa.FundingUK Medical Research Council.

Project description:BACKGROUND: Improved prevention and management of vascular disease is a global priority. Non-health care professionals (such as, 'lay health workers' and 'peer support workers') are increasingly being used to offer telephone support alongside that offered by conventional services, to reach disadvantaged populations and to provide more efficient delivery of care. However, questions remain over the impact of such interventions, particularly on a wider range of vascular related conditions (such as, chronic kidney disease), and it is unclear how different types of telephone support impact on outcome. This study assessed the evidence on the effectiveness and cost-effectiveness of telephone self-management interventions led by 'lay health workers' and 'peer support workers' for patients with vascular disease and long-term conditions associated with vascular disease. METHODS: Systematic review of randomised controlled trials. Three electronic databases were searched. Two authors independently extracted data according to the Cochrane risk of bias tool. Random effects meta-analysis was used to pool outcome measures. RESULTS: Ten studies were included, primarily based in community settings in the United States; with participants who had diabetes; and used 'peer support workers' that shared characteristics with patients. The included studies were generally rated at risk of bias, as many methodological criteria were rated as 'unclear' because of a lack of information.Overall, peer telephone support was associated with small but significant improvements in self-management behaviour (SMD = 0.19, 95% CI 0.05 to 0.33, I2 = 20.4%) and significant reductions in HbA1c level (SMD = -0.26, 95% CI -0.41 to -0.11, I2 = 47.6%). There was no significant effect on mental health quality of life (SMD = 0.03, 95% CI -0.12 to 0.18, I2 = 0%). Data on health care utilisation were very limited and no studies reported cost effectiveness analyses. CONCLUSIONS: Positive effects were found for telephone self-management interventions via 'lay workers' and 'peer support workers' for patients on diabetes control and self-management outcomes, but the overall evidence base was limited in scope and quality. Well designed trials assessing non-healthcare professional delivered telephone support for the prevention and management of vascular disease are needed to identify the content of effective components on health outcomes, and to assess cost effectiveness, to determine if such interventions are potentially useful alternatives to professionally delivered care.

Project description:PurposeDepression and anxiety afflict millions worldwide causing considerable disability. MULTI-PSYCH is a longitudinal cohort of genotyped and phenotyped individuals with depression or anxiety disorders who have undergone highly structured internet-based cognitive-behaviour therapy (ICBT). The overarching purpose of MULTI-PSYCH is to improve risk stratification, outcome prediction and secondary preventive interventions. MULTI-PSYCH is a precision medicine initiative that combines clinical, genetic and nationwide register data.ParticipantsMULTI-PSYCH includes 2668 clinically well-characterised adults with major depressive disorder (MDD) (n=1300), social anxiety disorder (n=640) or panic disorder (n=728) assessed before, during and after 12 weeks of ICBT at the internet psychiatry clinic in Stockholm, Sweden. All patients have been blood sampled and genotyped. Clinical and genetic data have been linked to several Swedish registers containing a wide range of variables from patient birth up to 10 years after the end of ICBT. These variable types include perinatal complications, school grades, psychiatric and somatic comorbidity, dispensed medications, medical interventions and diagnoses, healthcare and social benefits, demographics, income and more. Long-term follow-up data will be collected through 2029.Findings to dateInitial uses of MULTI-PSYCH include the discovery of an association between PRS for autism spectrum disorder and response to ICBT, the development of a machine learning model for baseline prediction of remission status after ICBT in MDD and data contributions to genome wide association studies for ICBT outcome. Other projects have been launched or are in the planning phase.Future plansThe MULTI-PSYCH cohort provides a unique infrastructure to study not only predictors or short-term treatment outcomes, but also longer term medical and socioeconomic outcomes in patients treated with ICBT for depression or anxiety. MULTI-PSYCH is well positioned for research collaboration.

Project description:BackgroundThe lack of trained mental health professionals is a key barrier to scale-up of evidence-based psychological interventions in low and middle-income countries. We have developed an app that allows a peer with no prior experience of health-care delivery to deliver the cognitive therapy-based intervention for perinatal depression, the Thinking Healthy Programme (THP). This trial aims to assess the effectiveness and cost-effectiveness of this Technology-assisted peer-delivered THP versus standard face-to-face Thinking Healthy Programme delivered by trained health workers.MethodsWe will employ a non-inferiority stratified cluster randomized controlled trial design comparing the two formats of intervention delivery. A total of 980 women in the second or third trimester of pregnancy with a diagnosis of Major Depressive Episode, evaluated with the Structured Clinical Interview for DSM-V Disorders (SCID), will be recruited into the trial. The unit of randomization will be 70 village clusters randomly allocated in a 1:1 ratio to the intervention and control arms. The primary outcome is defined as remission from major depressive episode at 3 months postnatal measured with the SCID. Data will also be collected on symptoms of anxiety, disability, quality of life, service use and costs, and infant-related outcomes such as exclusive breastfeeding and immunization rates. Data will be collected on the primary outcome and selected secondary outcomes (depression and anxiety scores, exclusive breastfeeding) at 6 months postnatal to evaluate if the improvements are sustained in the longer-term. We are especially interested in sustained improvement (recovery) from major depressive episode.DiscussionThis trial will evaluate the effectiveness and cost-effectiveness of a technology-assisted peer-delivered cognitive behavioral therapy-based intervention in rural Pakistan. If shown to be effective, the novel delivery format could play a role in reducing the treatment gap for perinatal depression and other common mental disorders in LMIC.Trial registrationThe trial was registered at Clinicaltrials.gov (NCT05353491) on 29 April 2022.

Project description:BACKGROUND:Despite an unparalleled global refugee crisis, there are almost no studies in primary care addressing real-world conditions and longer courses of treatment that are typical when resettled refugees present to their physician with critical psychosocial needs and complex symptoms. We studied the effects of a year of psychotherapy and case management in a primary care setting on common symptoms and functioning for Karen refugees (a newly arrived population in St Paul, Minnesota) with depression. METHODS:A pragmatic parallel-group randomized control trial was conducted at two primary care clinics with large resettled Karen refugee patient populations, with simple random allocation to 1 year of either: (1) intensive psychotherapy and case management (IPCM), or (2) care-as-usual (CAU). Eligibility criteria included Major Depression diagnosis determined by structured diagnostic clinical interview, Karen refugee, ages 18-65. IPCM (n?=?112) received a year of psychotherapy and case management coordinated onsite between the case manager, psychotherapist, and primary care providers; CAU (n?=?102) received care-as-usual from their primary care clinic, including behavioral health referrals and/or brief onsite interventions. Blinded assessors collected outcomes of mean changes in depression and anxiety symptoms (measured by Hopkins Symptom Checklist-25), PTSD symptoms (Posttraumatic Diagnostic Scale), pain (internally developed 5-item Pain Scale), and social functioning (internally developed 37-item instrument standardized on refugees) at baseline, 3, 6 and 12?months. After propensity score matching, data were analyzed with the intention-to-treat principle using repeated measures ANOVA with partial eta-squared estimates of effect size. RESULTS:Of 214 participants, 193 completed a baseline and follow up assessment (90.2%). IPCM patients showed significant improvements in depression, PTSD, anxiety, and pain symptoms and in social functioning at all time points, with magnitude of improvement increasing over time. CAU patients did not show significant improvements. The largest mean differences observed between groups were in depression (difference, 5.5, 95% CI, 3.9 to 7.1, P?<?.001) and basic needs/safety (difference, 5.4, 95% CI, 3.8 to 7.0, P?<?.001). CONCLUSIONS:Adult Karen refugees with depression benefited from intensive psychotherapy and case management coordinated and delivered under usual conditions in primary care. Intervention effects strengthened at each interval, suggesting robust recovery is possible. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT03788408. Registered 20 Dec 2018. Retrospectively registered.

Dataset Information

The Effect of Group Support Psychotherapy Delivered by Trained Lay Health Workers for Depression Treatment Among People with HIV in Uganda: Protocol of a Pragmatic, Cluster Randomized Trial.

Background

Objective

Methods

Results

Conclusions

Trial registration

Publications

The Effect of Group Support Psychotherapy Delivered by Trained Lay Health Workers for Depression Treatment Among People with HIV in Uganda: Protocol of a Pragmatic, Cluster Randomized Trial.

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