Twenty years of rising mental disorder burden in LMICs
Advances in treatment
Non-specialists can treat common mental disorders in low resource settings
Cost of inaction: the economics of mental health
An urgent need to scale
Applying new implementation designs to global mental health: stimulating progress
Effectiveness-implementation hybrid research designs
An effectiveness-implementation hybrid type I case example: HIV-positive women in Kenya
Medical anthropology has a major influence on the field of global mental health (GMH), with psychiatrist and medical anthropologist, Dr. Arthur Kleinman, conducting the first influential studies [6]. In some cases, anthropological research suggested that mental health diagnoses considered valid in one culture were not valid in populations that experienced and expressed emotions differently—the basis of the “category fallacy,” which led to debate about best practices in humanitarian aid and GMH treatment research. Partially reflecting the influence of medical anthropology, many treatment research studies are tightly indexed to the target population, often preceded by an ethnographically informed needs assessment—emphasizing assessment of the internal validity of diagnosis and treatment for the local/target community. While medical anthropology and ethnographic tools must remain cornerstones of an ethical approach to GMH treatment research, we suggest that implementation science, particularly effectiveness-implementation study designs, can build on this rich history, retaining a focus on internal validity while addressing today’s desperate need for broad scale up of mental health care for common disorders among diverse populations of adults in LMICs |
Setting
Needs assessment
IPT stage | Adaptation |
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Summary of adaptations for meeting, inventory and formulation and termination phases | |
Initial meetings (session 1–3) | Medical model of depression and PTSD in the setting of HIV, method and goals of IPT, interpersonal inventory including key components for study population: Disclosure of HIV status and its effects on relationships, GBV, housing and social support |
Interpersonal formulation (sessions 4–5) |
Local examples— |
Role conflict
| GBV, reproduction, condom use, HIV discordance in couple, inheritance |
Role transition
| HIV diagnosis, polygamy, single parenting, re-marriage, land disinheritance, separation from children |
Loss
| Family deaths secondary to HIV |
Middle sessions (6–10) | Use local resources to advance social support around the identified problem area, including HIV women’s groups, women’s church groups and women’s chamasa
|
Concluding (sessions 11–12) | Review successes, relapse prevention strategies |
Treatment selection: interpersonal psychotherapy (IPT)
Study designs. Encourage explicit use of implementation science in GMH treatment studies, leveraging new hybrid effectiveness-implementation designs at early stages of investigation Integrate within priority care systems Engage a reciprocal partnership with local and national policy makers and opinion leaders as well as health and mental health practitioners and researchers in the early stages of the treatment study, focused on scaling up mental health care to address local needs Continue and extend the GMH history of context-dependent adaptations of interventions to improve fit with population needs and service setting Develop criteria for selection of study personnel for sustained, collaborative implementation Use explicit strategies to develop local, sustainable methods of supervising non-specialist providers
Study outcomes. Emphasize policy-relevant outcomes for GMH: Evaluate treatment effect on health co-morbidities (e.g., HIV viral load, neurocognitive deficits and other communicable and non-communicable diseases) Conduct cost analyses (e.g., cost-benefit and changes in economic productivity) |
Adaptation, training and manual
Study design
Study component | Description |
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Treatment effectiveness: randomized controlled trial (RCT) within a routine clinical setting with minimal restrictions | |
Target population | HIV+ women affected by GBV with MDD and PTSD, enrolled in HIV care at the UCSF-KEMRI FACES clinic supported by PEPFAR, which treats >140,000 HIV+ individuals in the Nyanza region of Kenya |
Recruitment | Study information provided in waiting area for self-referral, HIV clinic providers alerted to the study and eligibility criteria |
Eligibility | HIV-infected women over age 18, enrolled in HIV care at FACES, PTSD secondary to GBV and MDD, absence of cognitive dysfunction, severe mood/thought disorders and substance abuse requiring a higher level/alternate care (qualitative needs assessment suggested that these criteria would identify a high proportion of HIV+GBV+ women in need of mental health care at FACES) |
Intervention | |
Concurrent treatment | Any mental health counseling/psychotherapy, psychotropic medication, ARV adherence counseling, couples therapy, other study participation and/or other psychosocial intervention at the FACES clinic or outside is allowed and noted |
Retention | For missed sessions or evaluations, participants are called up to four times and emergency contact is alerted |
RCT outcomes |
Primary: diagnosis of MDD/PTSD; Secondary: continuous measures of depression and PTSD symptoms, interpersonal functioning, anger, self-efficacy, substance use, quality of life, disability, HIV viral load, self-reported ARV adherence and neurocognitive functioning. Primary and secondary outcomes assessed at baseline and repeated at weeks 12, 24, 36 |
IPT adaptation and therapist training | Adaptations to IPT content and process to optimize fit while maintaining fidelity to IPT protocol, drawing on prior experience with IPT adaptation. Additional IPT adaptations were made based on feedback from therapist non-specialist trainees during 2 week formal IPT training and 12 week pilot cases |
Adherence to protocol | Evaluated after each session by an IPT study supervisor, using a session-specific IPT adherence monitoring, consisting of 9–10 items scored on a 10 point likert scale, including a reverse coded item. All sessions are audio-recorded and a random 20 % of sessions are evaluated by an independent rater |
Sample size | 220 |
Data analysis | Main analysis is comparison of change from baseline to post-treatment (12 weeks) between IPT+TAU and TAU. Maintenance of gains assessed by testing for significant change from 12 week to 24 and 36 week follow up assessments. Sub-group (sensitivity) analyses will be used to identify sub-groups for whom IPT+TAU is more or less effective |
Implementation factor | Goal | Strategy |
---|---|---|
Treatment implementation | ||
Study location | Deliver mental health care in patients’ preferred manner using a system that can be taken to scale | Integrate mental health treatment within the HIV clinic, with clear delineation of the treatment pathway, including case identification, treatment, discharge and referral decision rules |
Study personnel | Promote knowledge and integration of mental health care within the HIV clinic | Employ clinic staff as study personnel when possible |
Clinic staff involvement | Engage clinic staff in a dialogue on the need for and benefits of mental health care within the HIV clinic and develop a common understanding of potential facilitators and barriers to treatment | Key clinic staff serve as study advisors and attend weekly meeting—e.g., IPT peer supervision is attended by leaders of the clinic’s ARV adherence teama
|
Study treatment personnel | Evaluate the success of implementing mental health treatment delivered by local non-specialists | Train and employ local, non-specialists to provide low cost, mental health care |
Supervision | Build sustainable, local IPT supervision | IPT study therapists are supervised by IPT experts and by a weekly peer group of study therapists. During the study, supervision responsibility is transferred from experts to the local peer group |
Sampling frame | Optimize applicability of study | Broad eligibility |
Non mental health outcomes | Identify key correlates of mental health treatment: | |
HIV health | HIV health outcomes: viral load, ART adherence | |
Cognitive function | Neurocognitive testing | |
Economic gains | Cost-benefit analyses of mental health care for HIV+ women, including changes in formal and informal income | |
Psychosocial | Quality of life, functionality, re-victimization | |
Identify participant, therapist and clinic experience with delivering mental health treatment, including burden to clinic staff and suggestions for improvement | Qualitative interviews throughout and at the conclusion of the study, with integration of feedback to optimize treatment implementation parameters | |
Policy maker involvement | Collaborate with policy makers to create a scalable mental health treatment for HIV+ women in Kenya | Meet with local policy makers and invite them to the study, identify their data needs for scaling up mental health care, work to meet these needs |
Refinements for scale up | Refine treatment, delivery and stakeholder involvement to optimize the intervention for national scale up | Formative evaluation of using qualitative exit interviews with study participants, therapists, clinic staff, policy makers and other stakeholders |