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

• Register: ISRCTN
• Last refreshed on: 29 June 2020
• Main ID: ISRCTN72875710
• Date of registration: 12/02/2014
• Prospective Registration: Yes
• Primary sponsor: HealthNet TPO (Netherlands)
• Public title: An evaluation of the effectiveness of a psychological treatment for moderate to severe depression and harmful or dependent drinking in rural communities in Nepal
• Scientific title: 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
• Date of first enrolment: 01/05/2014
• Target sample size: 426
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN72875710
• Study type: Interventional
• Study design: Multi-centre single-blind pragmatic randomized controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Nepal

Contacts

• Name: Mark Jordans

Key inclusion & exclusion 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:
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).


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Depression disorder, alcohol use disorder
Mental and Behavioural Disorders

Intervention(s)

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

Patients are individually randomized. The sample size calculations are based on an estimated 80% power, and a 10% loss to follow-up.

The psychological treatment (PT): The PT was developed in a systematic process which built upon the experiences of the investigators in adapting mental health interventions for use in under-resourced and socio-culturally diverse contexts. The key principles of this approach were to dismantle evidence-based PTs and combine them with strategies identified as being useful in the local context. Evidence-based PTs were identified based on the Mental Health Gap Action Programme (mhGAP) guidelines (WHO) for use in primary care. Contextually appropriate strategies were identified through a review of explanatory models, PT studies and qualitative studies with persons with the target disorders, their care-givers and health care providers (including alternative and religious healers) about key outcomes and coping strategies. The strategies were collated and the list reduced by merging those that were similar. Strategies which were rated by local mental health providers and community health workers as being acceptable, safe and feasible for delivery in primary care were taken to the next stage of synthesis into a formal PT in intervention development workshops. The primary outcome at this stage was the identification of behavioural activation (BA) and Motivational Enhancement Therapy (MET) as the theoretical framework for the emerging PT for depression and alcohol use disorder, respectively. The next phase of treatment deve

Primary Outcome(s)

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 Outcome(s)

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.

Secondary ID(s)

N/A

Source(s) of Monetary Support

Department for International Development - HRPC10 Improving Mental Health Services in Low Income Countries (PRIME: http://www.prime.uct.ac.za/)

Results

• Results available: Yes
• Date Completed: 01/01/2016