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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 Counselling for Alcohol Problems (CAP), a lay counsellor-delivered psychological treatment for harmful and dependent drinking in primary care in India

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN76465238
Enrollment
373
Registered
2013-10-08
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

1. Harmful drinking 2. Alcohol dependence syndrome Mental and Behavioural Disorders

Interventions

Patients are randomised to receive either CAP or EUC. 1. Counselling for Alcohol Problems (CAP): CAP was developed in a systematic process which built upon the experiences of the investigators in ad
and qualitative studies with men with AUD, their care-givers and health care providers (including alternative and religious healers) about key outcomes and coping strategies. The strategies were colla

Sponsors

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

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Must be above the age of 18 but below the age of 65 2. Must reside within the 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 for HD and ADS in the past 3 months

Exclusion criteria

Exclusion criteria: 1. Patients who need urgent medical attention (defined as needing emergency treatment and/or in-patient admission) 2. Patients unable to communicate clearly (for example due to a speech or hearing disability) 3. Patients already receiving the PREMIUM counselling treatment Added 26/05/2015: 4. 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 alcohol (gms) consumed in one week, measured 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. 2. Alcohol Use Disorder severity score and remission measured as mean AUDIT score and an AUDIT score of <8, respectively. The AUDIT is a 10-item questionnaire with three questions on the amount and frequency of drinking, three questions on alcohol dependence, and four on problems caused by alcohol. 3. Physical, social, intrapersonal, impulsive and interpersonal consequences of alcohol measured as mean score on the Short Inventory of Problems (SIP), a 15-item questionnaire which assesses physical, social, intrapersonal, impulsive and interpersonal consequences of alcohol and drug consumption. Respondents indicate whether each item occurred in the previous 3 months and how frequently it occurred on a 3-point Likert scale.

Secondary

MeasureTime frame
1. Mean alcohol (gms) consumed in one week, measured using the Time Line Follow Back (TLFB), at 12 months post randomisation. 2. Alcohol Use Disorder severity score and remission measured as mean AUDIT score and an AUDIT score of <8 respectively, at 12 months post randomisation. 3. Physical, social, intrapersonal, impulsive and interpersonal consequences of alcohol measured as mean score on the Short Inventory of Problems (SIP), at 12 months post randomisation. 4. Mean difference in disability score and total disability days, measured at 3 and 12 months post randomisation, using the World Health Organisation Disability Assessment Schedule (WHODAS), 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. 5. Costs of illness (direct and indirect) and health service utilisation, measured at 12 months post randomisation, 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). 6. Uptake of detoxification services, measured at 3 and 12 months post randomisation, using an additional item on the CSRI. 7. Presence of depression and depression severity score, measured at 3 and 12 months post randomisation, using the Primary Health Questionnaire-9 (PHQ-9), a 9-item questionnaire which scores each of the DSM-IV criteria for depression on a scale of 0 to 3 based on how frequently they occur. 8. Suicidal thoughts or attempts, measured at 3 and 12 months post randomisation, assessed with item 9 of the PHQ-9 and with an additional question on suicide attempts, based on interviews used to assess suicidal behaviour in earlier studies in Goa. 9. Perpetration of intimate partner violence, measured at 3 and 12 months post randomisation, based on questions used in an earlier community survey of alcohol use in Goa. 10. Other seco

Countries

India

Outcome results

None listed

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