Problem-Solving Therapy for Older Adults at Risk for Depression: A Qualitative Analysis of the Depression in Later Life Trial.

OBJECTIVE: As a sequel to the Depression in Later Life trial of lay counselor-delivered problem-solving therapy for depression prevention among older adults in Goa, India, this qualitative study aimed to explore participant experiences to illuminate the reasons for the trial's positive findings and implications for further efforts at depression prevention in low-resource settings. METHODS: In-depth interviews were conducted with 19 participants (21% of those randomly assigned to the original intervention). Two independent raters coded the data and organized narratives according to broad themes. RESULTS: Most participants valued their relationship with the lay counselor, learned self-care strategies to cope with illnesses, and increased engagement in pleasurable social and physical activities. Some participants reported needing assistance with managing financial strain and family conflicts. CONCLUSIONS: The lay-counselor-delivered intervention was well received. The relationship with the counselor and behavioral activation toward better self-care and more-pleasurable activities may have been keys to the intervention's success.

Adaptation of problem-solving therapy for primary care to prevent late-life depression in Goa, India: the 'DIL' intervention.

BACKGROUND: Depression in late life is a major, yet unrecognized public health problem in low- and middle-income countries (LMICs). The dearth of specialist resources, together with the limited ability of current depression treatments to avert years lived with disability, underscores the need for preventive interventions that can be delivered by lay health workers in primary care settings. We describe the development of an intervention for the indicated prevention of depression in older adults at risk due to subsyndromal symptoms, attending rural and urban public primary care clinics in Goa, India. OBJECTIVES: (1) to describe a mixed-methods approach (qualitative and quantitative)to the development of 'DIL,' an intervention for preventing the onset of major depression in older adults living with subsyndromal symptoms in Goa, India; (2) to describe resulting components of the 'DIL' intervention; and (3) to present data on the feasibility, acceptability, and benefit of DIL to participants. METHODS: We followed a mixed-methods design, including in-depth interviews, focus group discussions, a theory of change workshop to develop a logic model, and an open-case series. RESULTS: The mixed-method approach led to the development and adaptation of the DIL (Depression in Later Life) intervention for the indicated prevention of depression in older adults. The intervention was delivered by lay health counselors (LHCs). 'DIL' is a hybrid model of simple behavioral strategies grounded in Problem-solving Therapy for Primary Care, improved self-management of common, co-occurring medical disorders such as diabetes mellitus, and pragmatic assistance in navigating to needed social services. The use of 'DIL' in an open-case series with 19 participants led to a moderate reduction in symptoms of depression and anxiety on the General Health Questionnaire. A pictorial flipchart was developed to assist in delivering the intervention to participants with low levels of literacy. High rates of participant retention and satisfaction were achieved. CONCLUSION: The DIL intervention was adapted to the local context for delivery by lay health counselors and was found to be acceptable and feasible among the elderly participants in the study.

Effect of a Lay Counselor Intervention on Prevention of Major Depression in Older Adults Living in Low- and Middle-Income Countries: A Randomized Clinical Trial.

Importance: Preventing depression in older adults living in low- and middle-income countries is important because of the scarcity of treatment resources and the risk of disability, suicide, and dementia. Objective: To assess whether an intervention for depression prevention provided by lay counselors is effective in older adults from low- and middle-income countries. Design, Setting, and Participants: This parallel-group randomized clinical trial with masked outcome assessment was performed in 181 older adults (≥60 years) with subsyndromal depressive symptoms at rural and urban primary care clinics in Goa, India. The first participant entered the trial on March 31, 2015, and the last exited on June 2, 2017. Data analysis used the intention-to-treat approach. Interventions: Lay counselors provided problem-solving therapy, brief behavioral treatment for insomnia, education in self-care of common medical disorders such as diabetes, and assistance in accessing medical and social programs. Main Outcomes and Measures: The main outcome was incidence of major depressive episodes. The study also assessed symptom change during 12 months (12-item General Health Questionnaire [GHQ-12]; score range of 0 to 12, with higher scores indicating greater symptoms of depression and anxiety), functional status (World Health Organization Disability Assessment Schedule 2.0; score range of 12 to 60, with higher scores indicating greater disability), cognition (Hindi Mini-Mental State Examination; score range of 0 to 30, with higher scores indicating better cognitive functioning), blood pressure, and body mass index to provide further clinical context. Results: The study enrolled 181 participants (mean [SD] age, 69.6 [7.2] years; 114 [63.0%] female): 91 to the intervention arm (depression in later life [DIL] intervention) and 90 to care as usual (CAU). Incident episodes of major depression were lower in the DIL intervention than in the CAU group (4.40% vs 14.44%; log-rank P = .04; number needed to treat, 9.95; 95% CI, 5.12-182.43). The 12-month Kaplan-Meier estimates of percentage of depression-free participants were 95.1% (95% CI, 90.5%-99.9%) in the DIL group vs 87.4% (95% CI, 80.4%-95.1%) in the CAU group. The incidence of depressive symptoms (GHQ-12) was also less (12-month mean difference, -1.18; 95% CI, -2.03 to -0.31; group × time interaction P < .001). There were no changes in measures of disability or cognition. The DIL intervention was associated with a significantly greater lowering of systolic blood pressure (12-month mean difference, -6.98; 95% CI, -11.96 to -2.01; group × time interaction P < .001) and change in body mass index (12-month mean difference, 0.23; 95% CI, -0.97 to 1.43; P = .04). Conclusions and Relevance: The DIL intervention is effective for preventing episodes of major depression in older persons with subsyndromal symptoms. If replicated, the DIL intervention may be effective in older adults living in low- and middle-income countries. Trial Registration: ClinicalTrials.gov Identifier: NCT02145429.

Aging and well-being in Goa, India: a qualitative study.

OBJECTIVES: The population of India is aging rapidly. This demographic shift brings with it a host of challenges to the health and well-being of older adults, including the increased prevalence of non-communicable diseases, among them depressive disorders. In this paper, we report on qualitative research intended to inform the development of a locally acceptable and appropriate intervention to improve the well-being of older adults in Goa, India and, specifically, to prevent late-life depression. METHOD: Semi-structured interviews with 20 individuals, aged 60 years and older, attending two primary care clinics in Goa, India. Transcripts were reviewed to identify emerging themes, a coding scheme was developed and thematic analyses were conducted. RESULTS: Analyses of the interview transcripts revealed the following key themes: (1) notions of old age tended to be negative and there were widespread fears of becoming widowed or incapacitated; (2) the most frequently reported health conditions were joint pain, diabetes and heart disease; (3) emotional distress was described using the terms 'tension', 'stress', 'worry' and 'thinking'; (4) family issues often involved financial matters, difficult relationships with daughters-in-law and conflicted feelings about living with the family or independently; (5) other than a pension scheme, participants did not know of community resources available to older adults. CONCLUSIONS: Our findings are in general agreement with those of previous research, and with our experiences of working with older adults in Pittsburgh and the Netherlands. This research will inform the development of an intervention to prevent depression in older adults in Goa.

Intervention development for the indicated prevention of depression in later life: the "DIL" protocol in Goa, India.

Because depression is a major source of the global burden of illness- related disability, developing effective strategies for reducing its incidence is an important public health priority, especially in low-income countries, where resources for treating depression are scarce. We describe in this report an intervention development project, funded by the US National Institute of Mental Health, to address "indicated" prevention of depression in older adults attending rural and urban primary care clinics in Goa, India. Specifically, participants in the "DIL" ("Depression in Later Life") trial were older adults living with mild, subsyndromal symptoms of depression and anxiety and thus at substantial risk for transitioning to fully syndromal major depression and anxiety disorders. Building upon the MANAS treatment trial ("Promoting Mental Health") led by Patel et al in the same locale, we present here lessons learned in the development and implementation of a protocol utilizing lay health counsellors (LHCs) who deliver a multi-component depression prevention intervention organized conceptually around Problem Solving Therapy for Primary Care (PST), with additional components addressing brief behavioural treatment of sleep disturbances such as insomnia, meeting basic social casework needs, and education in self- management of prevalent comorbid chronic diseases, such as diabetes mellitus. To our knowledge, DIL is the first randomized clinical trial addressing the prevention of depressive disorders ever conducted in a low- or middle-income country.

Cannabinoids for nausea and vomiting in adults with cancer receiving chemotherapy.

BACKGROUND: Cannabis has a long history of medicinal use. Cannabis-based medications (cannabinoids) are based on its active element, delta-9-tetrahydrocannabinol (THC), and have been approved for medical purposes. Cannabinoids may be a useful therapeutic option for people with chemotherapy-induced nausea and vomiting that respond poorly to commonly used anti-emetic agents (anti-sickness drugs). However, unpleasant adverse effects may limit their widespread use. OBJECTIVES: To evaluate the effectiveness and tolerability of cannabis-based medications for chemotherapy-induced nausea and vomiting in adults with cancer. SEARCH METHODS: We identified studies by searching the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO and LILACS from inception to January 2015. We also searched reference lists of reviews and included studies. We did not restrict the search by language of publication. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared a cannabis-based medication with either placebo or with a conventional anti-emetic in adults receiving chemotherapy. DATA COLLECTION AND ANALYSIS: At least two review authors independently conducted eligibility and risk of bias assessment, and extracted data. We grouped studies based on control groups for meta-analyses conducted using random effects. We expressed efficacy and tolerability outcomes as risk ratio (RR) with 95% confidence intervals (CI). MAIN RESULTS: We included 23 RCTs. Most were of cross-over design, on adults undergoing a variety of chemotherapeutic regimens ranging from moderate to high emetic potential for a variety of cancers. The majority of the studies were at risk of bias due to either lack of allocation concealment or attrition. Trials were conducted between 1975 and 1991. No trials involved comparison with newer anti-emetic drugs such as ondansetron. Comparison with placebo People had more chance of reporting complete absence of vomiting (3 trials; 168 participants; RR 5.7; 95% CI 2.6 to 12.6; low quality evidence) and complete absence of nausea and vomiting (3 trials; 288 participants; RR 2.9; 95% CI 1.8 to 4.7; moderate quality evidence) when they received cannabinoids compared with placebo. The percentage of variability in effect estimates that was due to heterogeneity rather than chance was not important (I(2) = 0% in both analyses).People had more chance of withdrawing due to an adverse event (2 trials; 276 participants; RR 6.9; 95% CI 1.96 to 24; I(2) = 0%; very low quality evidence) and less chance of withdrawing due to lack of efficacy when they received cannabinoids, compared with placebo (1 trial; 228 participants; RR 0.05; 95% CI 0.0 to 0.89; low quality evidence). In addition, people had more chance of 'feeling high' when they received cannabinoids compared with placebo (3 trials; 137 participants; RR 31; 95% CI 6.4 to 152; I(2) = 0%).People reported a preference for cannabinoids rather than placebo (2 trials; 256 participants; RR 4.8; 95% CI 1.7 to 13; low quality evidence). Comparison with other anti-emetics There was no evidence of a difference between cannabinoids and prochlorperazine in the proportion of participants reporting no nausea (5 trials; 258 participants; RR 1.5; 95% CI 0.67 to 3.2; I(2) = 63%; low quality evidence), no vomiting (4 trials; 209 participants; RR 1.11; 95% CI 0.86 to 1.44; I(2) = 0%; moderate quality evidence), or complete absence of nausea and vomiting (4 trials; 414 participants; RR 2.0; 95% CI 0.74 to 5.4; I(2) = 60%; low quality evidence). Sensitivity analysis where the two parallel group trials were pooled after removal of the five cross-over trials showed no difference (RR 1.1; 95% CI 0.70 to 1.7) with no heterogeneity (I(2) = 0%).People had more chance of withdrawing due to an adverse event (5 trials; 664 participants; RR 3.9; 95% CI 1.3 to 12; I(2) = 17%; low quality evidence), due to lack of efficacy (1 trial; 42 participants; RR 3.5; 95% CI 1.4 to 8.9; very low quality evidence) and for any reason (1 trial; 42 participants; RR 3.5; 95% CI 1.4 to 8.9; low quality evidence) when they received cannabinoids compared with prochlorperazine.People had more chance of reporting dizziness (7 trials; 675 participants; RR 2.4; 95% CI 1.8 to 3.1; I(2) = 12%), dysphoria (3 trials; 192 participants; RR 7.2; 95% CI 1.3 to 39; I(2) = 0%), euphoria (2 trials; 280 participants; RR 18; 95% CI 2.4 to 133; I(2) = 0%), 'feeling high' (4 trials; 389 participants; RR 6.2; 95% CI 3.5 to 11; I(2) = 0%) and sedation (8 trials; 947 participants; RR 1.4; 95% CI 1.2 to 1.8; I(2) = 31%), with significantly more participants reporting the incidence of these adverse events with cannabinoids compared with prochlorperazine.People reported a preference for cannabinoids rather than prochlorperazine (7 trials; 695 participants; RR 3.3; 95% CI 2.2 to 4.8; I(2) = 51%; low quality evidence).In comparisons with metoclopramide, domperidone and chlorpromazine, there was weaker evidence, based on fewer trials and participants, for higher incidence of dizziness with cannabinoids.Two trials with 141 participants compared an anti-emetic drug alone with a cannabinoid added to the anti-emetic drug. There was no evidence of differences between groups; however, the majority of the analyses were based on one small trial with few events. Quality of the evidence The trials were generally at low to moderate risk of bias in terms of how they were designed and do not reflect current chemotherapy and anti-emetic treatment regimens. Furthermore, the quality of evidence arising from meta-analyses was graded as low for the majority of the outcomes analysed, indicating that we are not very confident in our ability to say how well the medications worked. Further research is likely to have an important impact on the results. AUTHORS' CONCLUSIONS: Cannabis-based medications may be useful for treating refractory chemotherapy-induced nausea and vomiting. However, methodological limitations of the trials limit our conclusions and further research reflecting current chemotherapy regimens and newer anti-emetic drugs is likely to modify these conclusions.