The Healthy Activity Program (HAP), a lay counsellor-delivered brief psychological treatment for severe depression, in primary care in India: a randomised controlled trial.

BACKGROUND: Although structured psychological treatments are recommended as first-line interventions for depression, only a small fraction of people globally receive these treatments because of poor access in routine primary care. We assessed the effectiveness and cost-effectiveness of a brief psychological treatment (Healthy Activity Program [HAP]) for delivery by lay counsellors to patients with moderately severe to severe depression in primary health-care settings. METHODS: In this randomised controlled trial, we recruited participants aged 18-65 years scoring more than 14 on the Patient Health Questionnaire 9 (PHQ-9) indicating moderately severe to severe depression from ten primary health centres in Goa, India. Pregnant women or patients who needed urgent medical attention or were unable to communicate clearly were not eligible. Participants were randomly allocated (1:1) to enhanced usual care (EUC) alone or EUC combined with HAP in randomly sized blocks (block size four to six [two to four for men]), stratified by primary health centre and sex, and allocation was concealed with use of sequential numbered opaque envelopes. Physicians providing EUC were masked. Primary outcomes were depression symptom severity on the Beck Depression Inventory version II and remission from depression (PHQ-9 score of <10) at 3 months in the intention-to-treat population, assessed by masked field researchers. Secondary outcomes were disability, days unable to work, behavioural activation, suicidal thoughts or attempts, intimate partner violence, and resource use and costs of illness. We assessed serious adverse events in the per-protocol population. This trial is registered with the ISRCTN registry, number ISRCTN95149997. FINDINGS: Between Oct 28, 2013, and July 29, 2015, we enrolled and randomly allocated 495 participants (247 [50%] to the EUC plus HAP group [two of whom were subsequently excluded because of protocol violations] and 248 [50%] to the EUC alone group), of whom 466 (95%) completed the 3 month primary outcome assessment (230 [49%] in the EUC plus HAP group and 236 [51%] in the EUC alone group). Participants in the EUC plus HAP group had significantly lower symptom severity (Beck Depression Inventory version II in EUC plus HAP group 19·99 [SD 15·70] vs 27·52 [13·26] in EUC alone group; adjusted mean difference -7·57 [95% CI -10·27 to -4·86]; p<0·0001) and higher remission (147 [64%] of 230 had a PHQ-9 score of <10 in the HAP plus EUC group vs 91 [39%] of 236 in the EUC alone group; adjusted prevalence ratio 1·61 [1·34-1·93]) than did those in the EUC alone group. EUC plus HAP showed better results than did EUC alone for the secondary outcomes of disability (adjusted mean difference -2·73 [-4·39 to -1·06]; p=0·001), days out of work (-2·29 [-3·84 to -0·73]; p=0·004), intimate partner physical violence in women (0·53 [0·29-0·96]; p=0·04), behavioural activation (2·17 [1·34-3·00]; p<0·0001), and suicidal thoughts or attempts (0·61 [0·45-0·83]; p=0·001). The incremental cost per quality-adjusted life-year gained was $9333 (95% CI 3862-28 169; 2015 international dollars), with an 87% chance of being cost-effective in the study setting. Serious adverse events were infrequent and similar between groups (nine [4%] in the EUC plus HAP group vs ten [4%] in the EUC alone group; p=1·00). INTERPRETATION: HAP delivered by lay counsellors plus EUC was better than EUC alone was for patients with moderately severe to severe depression in routine primary care in Goa, India. HAP was readily accepted by this previously untreated population and was cost-effective in this setting. HAP could be a key strategy to reduce the treatment gap for depressive disorders, the leading mental health disorder worldwide. FUNDING: Wellcome Trust.

Short-term and Long-term Efficacy of Psychological Therapies for Irritable Bowel Syndrome: A Systematic Review and Meta-analysis.

BACKGROUND & AIMS: Several meta-analyses have demonstrated the efficacy of psychological therapies for reducing gastrointestinal (GI) symptoms in patients with irritable bowel syndrome (IBS). However, no meta-analysis has investigated the duration of these effects. We performed a meta-analysis to assess the immediate, short-term, and long-term efficacy of psychotherapy for reducing GI symptoms in adults with IBS. METHODS: We searched PubMed, PsycINFO, Science Direct, and ProQuest Dissertations and Theses through August 15, 2015 for randomized controlled trials that compared psychological therapy with an active or non-active comparison (control) condition for treatment of GI symptoms in adults with IBS. RESULTS: Forty-one trials were included in our meta-analysis, comprising data from 2290 individuals (1183 assigned to psychotherapy and 1107 assigned to a control condition). Compared with a mixed group of control conditions, psychological therapies had a medium effect on GI symptom severity (d¯ = 0.69) immediately after treatment. On average, individuals who received psychotherapy had a greater reduction in GI symptoms after treatment than 75% of individuals assigned to a control condition. After short-term follow-up periods (1-6 months after treatment) and long-term follow-up periods (6-12 months after treatment), this effect remained significant and medium in magnitude (d¯ = 0.76 and d¯ = 0.73, respectively). CONCLUSIONS: Psychological therapies reduce GI symptoms in adults with IBS. These effects remained significant and medium in magnitude after short-term and long-term follow-up periods.

Role of Mediators in Reducing Antepartum Depressive Symptoms in Rural Low-Income Women Receiving a Culturally Tailored Cognitive Behavioral Intervention.

Although cognitive behavioral interventions (CBIs) have demonstrated effectiveness for reducing depressive symptoms in the general population, the mechanism for reducing antepartum depressive symptoms (APDS) in rural low-income and minority women is unknown. This study tested the hypothesis that reducing stress and negative thinking, enhancing self-esteem, and increasing social-support will mediate the effect of a CBI on reducing APDS in rural low-income and minority women. Our findings show that CBI may work through reducing stress and negative thinking and enhancing self-esteem, but not social support. The findings also suggest that mental health care providers should emphasize these activities to reduce antepartum depressive symptoms.

A character-strengths based coaching intervention to improve wellbeing of rural community health workers in Madhya Pradesh, India: Protocol for a single-blind randomized controlled trial.

Background: There is scarce knowledge on the use of structured positive psychology interventions for reducing work-stress and improving wellbeing of rural community health workers in India, particularly the Accredited Social Health Activists (ASHAs) who are village-level (resident women, incentivised) lay health workers. This trial will test the effectiveness of a 'character-strengths' based coaching intervention compared to routine supervision on wellbeing ('authentic happiness') of ASHAs. Methods: This protocol is for a single-blind, parallel group randomized controlled trial comparing the effectiveness of a five-day residential workshop focusing on the use of character-strengths and subsequent 8- to 10-week remote telephonic coaching (weekly) to individually support ASHAs to improve their wellbeing, against routine health system support. The arms are intervention added to routine ASHA supervision (weekly, by the ASHA supervisor), and routine supervision alone (control arm). The target sample comprises 330 rural ASHAs in Madhya Pradesh, India. The primary outcome of mean Authentic Happiness Inventory (AHI) scores will be compared between arms at 3-month follow-up. Secondary outcomes will include an assessment of ASHA's self-reported affect, self-efficacy, flourishing, burnout, motivation, physical health symptoms, quality of life, and routine work performance indicators, and the consequent patient-level outcomes [e.g., service satisfaction and depression remission rates after receiving brief psychological treatment by trained ASHAs]. We will also evaluate the costs of developing and delivering the intervention. Discussion: This trial will determine whether a character-strengths based coaching intervention is an effective and scalable approach for reducing work-stress and improving wellbeing of rural ASHAs in low-resource settings.

"We are everyone's ASHAs but who's there for us?" a qualitative exploration of perceptions of work stress and coping among rural frontline workers in Madhya Pradesh, India.

OBJECTIVE: More than a million female village-level lay providers called 'Accredited Social Health Activists (ASHAs)', who deliver primary care, face high levels of stress due to work demands and low compensation, within the context of poverty and gender inequality. Evidence on ASHAs has focused on workplace challenges from a system perspective, without sufficient probing into individual-level stress. This study aims to gain perspectives into the experiences of work stress, the related health symptoms, and the responses to stress among ASHAs in India. METHODS: Focus group discussions (FGDs) conducted with ASHAs in Sehore district, Madhya Pradesh, were audio-recorded and transcribed. Grounded theory was used to generate themes under the various domains of ASHAs' work and domestic life. We identified pathways between the conditions that trigger stressful events, experiences of these events, resulting perceptions, effects on health and wellbeing, and approaches used by ASHAs to respond to stress. RESULTS: Six FGDs with 59 ASHAs generated the following themes: (a) Facility: Workload, undue pressures, unstructured work; ASHAs' relationships with seniors (e.g., feelings of being disrespected, blamed, or targeted), and low access to physical and administrative resources; (b) Home: Feelings of guilt for putting less time for family/child care; disrespect by the elderly for a poorly incentivised job; (c) Community: Low acceptance by the villagers; caste- and gender-bias; difficult community-level relationships (emotional labour, fear/stigma towards her services); (d) Somatic and psychological symptoms: headache, exhaustion, depressive symptoms (to cite a few); and (e) Responses to stress: Motivation (support from peers, family, a sense of identity/pride, incentives), Individual strengths (e.g., social responsibility), and spiritual recourse mechanisms. CONCLUSIONS: This study will inform the development of a strengths-based coaching intervention to address work stress among ASHAs. The findings are relevant to building the evidence on alleviation of work stress among female frontline cadres in low-resource settings globally.

A Patient Stratification Approach to Identifying the Likelihood of Continued Chronic Depression and Relapse Following Treatment for Depression.

BACKGROUND: Subgrouping methods have the potential to support treatment decision making for patients with depression. Such approaches have not been used to study the continued course of depression or likelihood of relapse following treatment. METHOD: Data from individual participants of seven randomised controlled trials were analysed. Latent profile analysis was used to identify subgroups based on baseline characteristics. Associations between profiles and odds of both continued chronic depression and relapse up to one year post-treatment were explored. Differences in outcomes were investigated within profiles for those treated with antidepressants, psychological therapy, and usual care. RESULTS: Seven profiles were identified; profiles with higher symptom severity and long durations of both anxiety and depression at baseline were at higher risk of relapse and of chronic depression. Members of profile five (likely long durations of depression and anxiety, moderately-severe symptoms, and past antidepressant use) appeared to have better outcomes with psychological therapies: antidepressants vs. psychological therapies (OR (95% CI) for relapse = 2.92 (1.24-6.87), chronic course = 2.27 (1.27-4.06)) and usual care vs. psychological therapies (relapse = 2.51 (1.16-5.40), chronic course = 1.98 (1.16-3.37)). CONCLUSIONS: Profiles at greater risk of poor outcomes could benefit from more intensive treatment and frequent monitoring. Patients in profile five may benefit more from psychological therapies than other treatments.

Factors associated with concomitant psychotropic drug use in the treatment of major depression: a STAR*D Report.

INTRODUCTION: Concomitant psychotropic medication (CPM) treatment is common in persons with major depression (MDD). However, relationships with patient characteristics and response to treatment are unclear. METHODS: Participants with nonpsychotic MDD (N=2682) were treated with citalopram, 20-60 mg/day. Sociodemographic, clinical, and treatment outcome characteristics were compared between those using CPMs at study entry or during up to 14 weeks of citalopram treatment, and non-users. RESULTS: About 35% of participants used a CPM. Insomnia was the predominant indication (70.3%). CPM users were more likely to be seen in primary care settings (69.3% versus 30.7%), be white, of non-Hispanic ethnicity, married, and have a higher income, private insurance, and certain comorbid disorders. CPM users had greater depressive severity, poorer physical and mental functioning, and poorer quality of life than non-users. Response and remission rates were also lower. CPM users were more likely to achieve >50 mg/day of citalopram, to report greater side effect intensity, and to have serious adverse events, but less likely to be intolerant of citalopram. CONCLUSION: CPMs are associated with greater illness burden, more Axis I comorbidities (especially anxiety disorders), and lower treatment effectiveness. This suggests that CPM use may identify a more difficult to treat population that needs more aggressive treatment.

The effects of cognitive-behavior therapy for depression on repetitive negative thinking: A meta-analysis.

It is not clear if treatments for depression targeting repetitive negative thinking (RNT: rumination, worry and content-independent perseverative thinking) have a specific effect on RNT resulting in better outcomes than treatments that do not specifically target rumination. We conducted a systematic search of PsycINFO, PubMed, Embase and the Cochrane library for randomized trials in adolescents, adults and older adults comparing CBT treatments for (previous) depression with control groups or with other treatments and reporting outcomes on RNT. Inclusion criteria were met by 36 studies with a total of 3307 participants. At post-test we found a medium-sized effect of any treatment compared to control groups on RNT (g = 0.48; 95% CI: 0.37-0.59). Rumination-focused CBT: g = 0.76, <0.01; Cognitive Control Training: g = 0.62, p < .01; CBT: g = 0.57, p < .01; Concreteness training: g = 0.53, p < .05; and Mindfulness-based Cognitive Therapy: g = 0.42, p < .05 had medium sized and significantly larger effect sizes than other types of treatment (i.e., anti-depressant medication, light therapy, engagement counseling, life review, expressive writing, yoga) (g = 0.14) compared to control groups. Effects on RNT at post-test were strongly associated with the effects on depression severity and this association was only significant in RNT-focused CBT. Our results suggest that in particular RNT-focused CBT may have a more pronounced effect on RNT than other types of interventions. Further mediation and mechanistic studies to test the predictive value of reductions in RNT following RNT-focused CBT for subsequent depression outcomes are called for.