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An evaluation of the effectiveness of a psychological treatment for moderate to severe depression and harmful or dependent drinking in rural communities in Nepal

Evaluating the effectiveness of community counsellor-delivered psychological treatment in reducing moderate to severe depression and harmful or dependent drinking compared to enhanced usual care in primary health facilities in Nepal: A pragmatic randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN72875710
Enrollment
426
Registered
2014-02-12
Start date
2014-05-01
Completion date
Unknown
Last updated
2020-06-29

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

Conditions

Depression disorder, alcohol use disorder Mental and Behavioural Disorders

Interventions

The study has the following two arms: 1. Enhanced Usual Care (EUC) (PRIME MHCP) = control arm 2. EUC + Psychological Treatment (PT) = treatment arm Pa

Sponsors

HealthNet TPO (Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Primary health care attendees above the age of 16 years 2. Intending to reside at the same address in the catchment area of the health care facility for at least the forthcoming 12 months (to enable the research team to complete review assessments) 3. Screened positive for depression or alcohol use disorder. 3.1. The Patient Health Questionnaire (PHQ-9) is a 9-item questionnaire that will be used for the detection of depression. 3.2. The Alcohol Use Disorders Identification Test (AUDIT) is a 10-item screening questionnaire that will be used for the detection of alcohol use disorder.

Exclusion criteria

Exclusion criteria: 1. Pregnant women 2. Patients who need urgent medical attention (defined as needing emergency treatment and/or in-patient admission) or are unable to communicate clearly (for example due to a speech or hearing disability).

Design outcomes

Primary

MeasureTime frame
1. Depression symptoms, measured with the Patient Health Questionnaire; 9-item questionnaire assessment of depressive symptoms assessed on a scale of 0 to 3; measured at baseline, 3 months and 12 months. 2. Alcohol use disorder symptoms, measured with the Alcohol Use Disorders Identification Test; 10-item questionnaire with 3 questions on the amount and frequency of drinking, 3 questions on alcohol dependence, and 4 on problems caused by alcohol; measured at baseline, 3 months and 12 months. 3. Functional impairment, measured with the WHO Disability Assessment Scale; 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; measured at baseline, 3 months and 12 months.

Secondary

MeasureTime frame
1. Alcohol consumption in past two weeks, using the Time Line Follow Back (TLFB), a calendar tool supplemented by memory aids to obtain retrospective estimates of daily drinking over a specified time period; measured at baseline, 3 and 12 months follow-up. 2. Cost of illness, using the Client Service Receipt Inventory (CSRI), a questionnaire to collect data on the utilisation and costs of health care and lost productivity (including that of care-givers); measured at baseline, 3 and 12 months follow-up. 3. Adverse consequences of alcohol consumption, using the Short Inventory of Problems (SIP), 15-item questionnaire which assesses physical, social, intrapersonal, impulsive, and interpersonal consequences of alcohol consumption; measured at baseline, 3 and 12 months follow-up. 4. Suicide plans and attempts, using the CIDI Suicidal Behaviours subscale, 8 items on suicide attempts; measured at baseline, 3 and 12 months follow-up. 5. Perceived social support; mean total score, using the OSLO-3, 3-item social support scale; measured at baseline, 3 and 12 months follow-up. 6. Perceived stigma, using the Patient experience of stigma and discrimination (ISMI); 8-item scale on perceived stigma among mental health patients; measured at baseline, 3 and 12 months follow-up.

Countries

Nepal

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026