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Program for effective mental health interventions in under-resourced health systems

A randomised controlled trial of the effectiveness and cost-effectiveness of the Healthy Activity Program (HAP), a lay counsellor-delivered psychological treatment for moderate to severe depression in primary care in India

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN95149997
Enrollment
450
Registered
2013-10-07
Start date
2013-10-28
Completion date
Unknown
Last updated
2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General adult depression Mental and Behavioural Disorders

Interventions

Patients are randomised to receive either HAP or EUC. The Health Activity Program (HAP): The psychological treatment was named the Healthy Activity Program and consisted of up to eight sessions in t

Sponsors

London School of Hygiene and Tropical Medicine (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Must be above the age of 18 but below the age of 65 2. Must reside within the geographic area which is selected for the PHC 3. Must plan to stay at the same address for at least 12 months 4. Must be able to speak one of the following languages: Konkani/Hindi/Marathi/English 5. Must not have been screened in the previous 3 months

Exclusion criteria

Exclusion criteria: 1. Pregnant women 2. Patients with drinking problems (as the guidelines require such patients to be treated first for drinking problems and this will be handled in a companion trial) 3. Patients who need urgent medical attention (defined as needing emergency treatment and/or in-patient admission) 4. Patients unable to communicate clearly (for example due to a speech or hearing disability) 5. In receipt of PREMIUM counselling treatment Added 26/05/2015: 6. Patient lives together in the same household with previously recruited patient or is in regular contact with previously recruited patient(s)

Design outcomes

Primary

MeasureTime frame
1. Mean difference in total score measured by the Beck's Depression Inventory (BDI-II), at 3 months , a 21-item questionnaire assessment of depressive symptoms; each item is scored on a Likert scale of f 0 to 3. It measures depression severity based on symptom scores 2. Remission, defined as a score of <10 measured at 3 months by the Patient Health Questionnaire (PHQ-9), a nine-item questionnaire for the detection and diagnosis of depression based on DSM-IV criteria. It is scored on a scale of 0 to 3 based on frequency of symptoms

Secondary

MeasureTime frame
1. Mean difference in total score measured by the Beck's Depression Inventory (BDI-II) at 12 months 2. Remission defined as a score of <10 on the Patient Health Questionnaire (PHQ-9) at 12 months 3. Mean difference in disability score measured by the World Health Organisation Disability Assessment Schedule (WHODAS) at 3 and 12 months, a 12-item questionnaire for measuring functional impairment over the previous 30 days. In addition, two items assess number of days the person was unable to work in the previous 30 days 4. Costs of illness (direct and indirect) measured by the Client Service Receipt Inventory at 3 and 12 months, a questionnaire to collect data on the utilisation and costs of health care and lost productivity (including that of care-givers) 5. Suicidal thoughts or attempts: assessed with item 9 of the PHQ-9 and with an additional question on suicide attempts at 12 months, based on interviews used to assess suicidal behaviour in earlier studies in Goa 6. Experience of intimate partner violence at 3 and 12 months, based on questions used in an earlier study of women's mental health in Goa 7. Level of activation based on an adapted version of the Behavioural Activation for Depression Scale- short form (BADS-SF) assessed within the last week at 3 and 12 months 8. Other secondary outcomes: change in marital status, employment status, based on a sociodemographic questionnaire at 3 and 12 months

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026