Innovation summary

Depression is the leading mental health contributor to the global burden of disease1. With a global prevalence rate of 4.7%2, it has been found to significantly impair quality of life, social functioning and workforce participation among people with the common mental disorder3. The treatment gap for people with depression who do not have access to psychological treatments in India exceeds 90%4.

An initiative under Program for Effective Mental Health Interventions in Under-Resourced Health Systems (PREMIUM) project, the Healthy Activity Program (HAP) was developed to address the need for culturally appropriate, affordable, and feasible treatment for severe depression delivered in primary care in under-resourced settings. 

  • A randomized controlled trial was designed and implemented to test the effectiveness of the Healthy Activity Program in Goa, India
  • This particular trial adds significant value from a low-income and middle-income country assessing the effectiveness and cost-effectiveness of a psychological treatment for moderately severe to severe depression in primary care

Impact summary

  • In the RCT, 493 participants were randomized to receive enhanced usual care (EUC, 245) or EUC and HAP (248)
  • HAP also had a strong intervention effect on depression remission, with 64% of participants meeting criteria in the EUC plus HAP group compared with 39% of in the EUC alone group.  These results were maintained at the 12 month follow-up
  • HAP has an 87% chance of being considered cost-effective from a health system perspective in the state of Goa

Innovation details

Much of the global evidence supporting psychological treatments comes from specialist settings in high-income countries and the generalisability of the findings to low-income and middle-income countries can be limited2.

The goal of the Program for Effective Mental Health Interventions in Under-Resourced Health Systems (PREMIUM) was to develop and assess scalable psychological treatments that are culturally appropriate, affordable, and feasible for delivery by non-specialist health workers and apply these treatments to the two leading mental health disorders. The Healthy Activity Program (HAP) was designed to address and manage moderately severe to severe depression through:

  • Lay counsellors in primary health care. Lay counsellors are health workers with limited specialised knowledge of mental healthcare
  • Strategies to address depression include interpersonal communication, rumination, sleep problems, tobacco cessation, and relaxation as needed.

Various adaptations were made to enhance the contextual acceptability and feasibility of the treatment including:

  • Home-based delivery
  • Use of pictorial patient resource materials
  • Strategies to encourage involvement of a significant other in treatment
  • Utilizing peer groups to mitigate the burden of supervision by experts

Randomized Controlled Trial

Participants between 18-65 years of age with a probable diagnosis of moderately severe to severe depression, ascertained with a Patient Health Questionnaire 9 score of more than 14 were recruited for the trial in 10 primary health centres in Goa, India. The study involved conducting a randomized controlled trial with 493 participants who were randomized (1:1) to receive:

  • Enhanced usual care (i.e. usual care at primary health center, screening results provided to patient and clinician, a contextualized manual for treating depression by the World Health Organization’s Mental Health Gap Action Program)
  • EUC and HAP (treatment arm) that consisted of 6-8 sessions lasting 30-40 minutes focusing on behavioural activation, psychoeducation, activity monitoring, activity management, problem solving and social network activation

Challenges

Brevity of intervention

Our emphasis on the brevity of the intervention could have been a contributing factor to a third of participants remaining depressed after treatment. The results in this study are restricted to the primary endpoint outcomes at 3 months for which our interest lies in the response and remission to our treatment of participants with moderately severe to severe depression. We intend to assess the sustainability of these outcomes, including recovery from depression, at a 12 month follow-up.

Interviews

Diagnostic interviews were not carried out at baseline, although PHQ-9 is widely used to define case-level morbidity in trials and, importantly, we used locally validated cutoffs in this study.

Continuation

Further research should focus on replication of our findings and dissemination of HAP in routine care settings in diverse contexts.

Partners

Funders

Evaluation methods

Outcomes

  • Primary outcomes in the RCT were depression severity, measured by the Beck Depression Inventory (BDI-II) and a remission in depression as defined by the Patient Health Questionnaire (PHQ-9)
  • Secondary outcomes in the RCT included recovery from depression (PHQ-9), partial absence of symptoms, disability (WHODAS 2.0), suicidal behaviour and intimate partner violence

Quality & Supervision

  • An international expert in behavioural activation (SD) trained and provided ongoing supervision for five local specialists, who in turn provided onsite training and supervision for lay counsellors
  • Analyses were on an intention-to-treat basis with use of multiple imputation for those with missing outcome data
  • Participants completed assessments at baseline, 3 months and 12 months after baseline

Cost of implementation

The intervention cost was significantly higher in the treatment arm than in the enhanced control arm, with better QALY scores.

HAP had a favourable cost per QALY gained and an 87% chance of being considered cost-effective from a health system perspective in the state of Goa.

Impact details

Baseline Assessment

  • Approximately 8% of the total patient population (31,888) screened had moderate to severe depression on the PHQ-9.
  • 248 patients were randomly allocated to EUC and 247 were randomly allocated to EUC plus HAP, two of whom were subsequently excluded from the EUC plus HAP group (one withdrew consent and the other was erroneously enrolled in both CAP and HAP trials), leaving a total of 245 patients given EUC plus HAP.

Outcomes at three months

  • 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).
  • Strong evidence for intervention effect was noted on depression symptom severity as demonstrated by a mean BDI-II score of 19.99 (intervention arm) vs 27.52 (treatment arm) [95% CI; p<0.0001) and was effective in the treatment of moderately severe and severe depression.
  • HAP produced a moderate effect on depressive symptoms, an almost two-thirds increase in remission, and small effects on secondary outcomes related to functional impairment after only six to eight sessions of treatment.

Outcomes at 12 months

  • 447 (91%) completed the 12 month follow up assessments of outcome
  • HAP participants maintained the gains they showed at the end of treatment through the 12 month period, with lower symptom severity scores than participants who received EUC alone and higher rates of remission

References

  1. Patel V, Chisholm D, Parikh R, Charlson FJ, Degenhardt L, Dua T, Ferrari AJ, Hyman S, Laxminarayan R, Levin C, Lund C. Addressing the burden of mental, neurological, and substance use disorders: key messages from Disease Control Priorities. The Lancet. 2016 Apr 16;387(10028):1672-85. [Link]
  2. Ferrari AJ, Somerville AJ, Baxter AJ, Norman R, Patten SB, Vos T, Whiteford HA. Global variation in the prevalence and incidence of major depressive disorder: a systematic review of the epidemiological literature. Psychological medicine. 2013 Mar;43(3):471-81. [Link]
  3. Chisholm D, Sweeny K, Sheehan P, Rasmussen B, Smit F, Cuijpers P, Saxena S. Scaling-up treatment of depression and anxiety: a global return on investment analysis. The Lancet Psychiatry. 2016 May 1;3(5):415-24. [Link]
  4. Patel V, Xiao S, Chen H, Hanna F, Jotheeswaran AT, Luo D, Parikh R, Sharma E, Usmani S, Yu Y, Druss BG. The magnitude of and health system responses to the mental health treatment gap in adults in India and China. The Lancet. 2016 Dec 17;388(10063):3074-84. [Link]

Research

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Associates

Abhijit Nadkarni
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