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NCT Number: NCT07260149

Coordinated Care for Alcohol Problems

Parallel group individually randomised controlled trial (RCT) with stratified (by severity of drinking problem) randomisation into intervention and control arms. Aim is to test the effectiveness and cost-effectiveness of Coordinated Care for Alcohol Problems (CCAP) for the whole spectrum of drinking problems in primary care in Goa, India. Primary outcome is the drinking outcome of percentage days abstinent (PDA) at three months post randomisation. Secondary outcomes include drinking outcomes (PDA at six- and 12- months post-randomisation; percentage days heavy drinking (PDHD), intensity of drinking and remission) and drinking related outcomes (e.g., injuries, violence) at three-, six- and 12- months post- randomisation. Participants will include consenting adult (>18 years) men with drinking problems attending Primary Healthcare Centres (PHCs) and Community Healthcare Centres (CHCs) in Goa and have drinking problems defined as scoring >8 on the Alcohol Use Disorder Identification Test (AUDIT). CCAP is a multi-component evidence-informed complex intervention package for coordinating treatment for all levels of problem drinking (hazardous, harmful, dependent). For hazardous drinking, it includes Mobile based Brief Intervention Treatment (M-BIT), which is a mobile-messaging brief intervention delivered via WhatsApp over eight weeks using multimedia content including contextually relevant messages, images and videos. For harmful drinking, it includes Counselling for Alcohol Problems Plus (CAP+) which is Counselling for Alcohol Problems (CAP), an evidence-based brief psychological treatment, integrated with strategies to enhance treatment engagement (entry into and completion). For dependent drinking, it includes Community Orientated Treatment for Alcohol Dependence (CONTAD) which is supervised home-detoxification over a week followed by a psychological treatment to prevent relapse, both integrated with treatment engagement strategies. CAP+ and CONTAD will be delivered in the community by non-specialist health workers (NSHW).

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scoring positive for problem drinking (≥ 8 on the AUDIT)
  • Have been residing in Goa for more than 12 continuous preceding months as an indicator of stability of residence which would be required both for treatment delivery and completion of outcome evaluation.
  • Language:
  • For hazardous drinking (AUDIT score of 8-15), patients must be able to understand at least one of the local vernacular languages (Hindi or Konkani) or English. Patients must be able to read at least one of the local vernacular languages (Hindi or Marathi) or English.
  • For harmful and dependent drinking (AUDIT score of >15), patients must be able to understand and speak any of the local vernacular languages (Konkani, Marathi, Hindi) or English.
  • For hazardous drinking, patients must also have access to a personal smartphone with WhatsApp.
  • For dependent drinking (AUDIT score of >19), patients must consent for home visits and must also be eligible for home detoxification as per structured detoxification protocol.

Exclusion criteria

  • For hazardous drinking, patients with significant visual or hearing impairment will be ineligible due to the audio-visual nature of the intervention.
  • For harmful and dependent drinking, patients with significant speech, hearing, or language impairment (as evident during screening) will be excluded as the intervention is primarily a 'talking treatment'.
  • For patients who present to the PHC/CHC needing urgent medical attention (emergency treatment or in-patient admission), screening will be deferred until their condition is stable.
  • Those who are alcohol dependent and do not meet the eligibility criteria for home detoxification as per protocol.
  • Those who are alcohol dependent but are currently not drinking. As AUDIT covers a period of 12 months, it will also detect those who meet the criteria for alcohol dependence over the past 12 months but are currently abstinent (hence not eligible for detoxification).

Treatment and study plan

CCAP

Behavioral

Hazardous drinking: The content of the intervention includes seven themes: health education, alcohol reduction, drinking and risk management, drinking alternatives, situational content, urge management, and relapse prevention. Participants will receive texts and video-based messages building their awareness about drinking and associated harms.

Harmful drinking: CAP has three phases which are delivered in one to four sessions over six to eight weeks by NSHWs. Each session lasts between 30 to 45 minutes. The content is delivered through motivational interviewing with additional behavioural and cognitive components. CAP+ will include treatment engagement strategies integrated into CAP.

Dependent drinking: Home detoxification will be supervised by a doctor and monitored by the NSHW and a designated carer (e.g. spouse) for the patient at their home-setting. The counselling sessions are delivered by NSHWs, over 4-8 weeks and lasting 30-60 minutes each.

Enhanced Usual Care

Behavioral

Hazardous drinking: An information sheet/brochure with information on alcohol consumption, associated risks, and tips to manage and reduce drinking.

Harmful drinking: CAP psychological brief treatment delivered by trained NSHWs (described above in detail).

Dependent drinking: Hospital-based detoxification delivered in secondary or tertiary care.

Primary outcomes

  1. Percentage days abstinent (PDA) [Parent trial]

    Time frame: 3 months post randomisation

    Proportion of days abstinent in the past two weeks measured using the Timeline Follow Back (TLFB)

  2. Pattern of drinking [Sub-group A Hazardous drinking]

    Time frame: 3 months post randomisation

    Number of heavy drinking days in the past two weeks measured using the TLFB

  3. Treatment completion [Sub-group B Harmful Drinking]

    Time frame: Through the period of intervention delivery, an average of 3 months

    Proportion of consented participants who go on to complete treatment defined as planned discharge which would be one of the following

    • Received all sessions as per protocol
    • Discharge by mutual agreement between NSHW and participant on achievement of treatment goals
    • Referral out of the study

  4. Intensity of drinking [Sub-group C Dependent drinking]

    Time frame: 3 months post randomisation

    Units of alcohol consumed in the past week measured using the TLFB

Secondary outcomes

  1. Percentage days abstinent (PDA) [Parent trial]

    Time frame: 6 months post randomisation

    Proportion of days abstinent in the past two weeks measured using the Timeline Follow

  2. Percentage days abstinent (PDA) [Parent trial]

    Time frame: 12 months post randomisation

    Proportion of days abstinent in the past two weeks measured using the Timeline Follow

  3. Consequences of alcohol use [Parent trial]

    Time frame: 3 months post randomisation

    Physical, social, intrapersonal and interpersonal consequences of alcohol use measured using the Short Inventory of Problems (SIP)

  4. Consequences of alcohol use [Parent trial]

    Time frame: 6 months post randomisation

    Physical, social, intrapersonal and interpersonal consequences of alcohol use measured using the Short Inventory of Problems (SIP)

  5. Consequences of alcohol use [Parent trial]

    Time frame: 12 months post randomisation

    Physical, social, intrapersonal and interpersonal consequences of alcohol use measured using the Short Inventory of Problems (SIP)

  6. Food security [Parent trial]

    Time frame: 12 months post randomisation

    Improvement of food security as measured using Food Insecurity Experience Scale

  7. Pattern of drinking [Parent trial]

    Time frame: 3 months post randomisation

    Percentage days heavy drinking (PDHD) in the past two weeks measured using the TLFB

  8. Pattern of drinking [Parent trial]

    Time frame: 6 months post randomisation

    Percentage days heavy drinking (PDHD) in the past two weeks measured using the TLFB

  9. Pattern of drinking [Parent trial]

    Time frame: 12 months post randomisation

    Percentage days heavy drinking (PDHD) in the past two weeks measured using the TLFB

  10. Intensity of drinking [Parent trial]

    Time frame: 3 months post randomisation

    Grams ethanol consumed per drinking day in the past two weeks measured using the TLFB

  11. Intensity of drinking [Parent trial]

    Time frame: 6 months post randomisation

    Grams ethanol consumed per drinking day in the past two weeks measured using the TLFB

  12. Intensity of drinking [Parent trial]

    Time frame: 12 months post randomisation

    Grams ethanol consumed per drinking day in the past two weeks measured using the TLFB

  13. Remission [Parent trial]

    Time frame: 3 months post randomisation

    Alcohol Use Disorder Identification Test (AUDIT) score <8

  14. Remission [Parent trial]

    Time frame: 6 months post randomisation

    Alcohol Use Disorder Identification Test (AUDIT) score <8

  15. Remission [Parent trial]

    Time frame: 12 months post randomisation

    Alcohol Use Disorder Identification Test (AUDIT) score <8

  16. System-level costs [Parent trial]

    Time frame: Monthly, during the period of implementation

    Economic costs in WHO six building blocks for delivering the interventions measured using inventory form for collecting system-level economic costs of delivering interventions (finance records and individuals involved in delivery of interventions)

  17. Out-of-pocket costs 1 [Parent trial]

    Time frame: 3 months post randomisation

    Out-of-pocket costs for receiving general medical care and the related non-medical costs (e.g.: time loss, travel, etc) measured using Client Service Receipt Inventory form for collecting costs to patients who receive CCAP interventions

  18. Out-of-pocket costs 1 [Parent trial]

    Time frame: 6 months post randomisation

    Out-of-pocket costs for receiving general medical care and the related non-medical costs (e.g.: time loss, travel, etc) measured using Client Service Receipt Inventory form for collecting costs to patients who receive CCAP interventions

  19. Out-of-pocket costs 1 [Parent trial]

    Time frame: 12 months post randomisation

    Out-of-pocket costs for receiving general medical care and the related non-medical costs (e.g.: time loss, travel, etc) measured using Client Service Receipt Inventory form for collecting costs to patients who receive CCAP interventions

  20. Out-of-pocket costs 2 [Parent trial]

    Time frame: 3 months post randomisation

    Out-of-pocket costs for receiving CCAP interventions (e.g.: time loss, travel, etc) using survey form for receiving the CCAP interventions to patients who receive CCAP interventions

  21. Out-of-pocket costs 2 [Parent trial]

    Time frame: 6 months post randomisation

    Out-of-pocket costs for receiving CCAP interventions (e.g.: time loss, travel, etc) using survey form for receiving the CCAP interventions to patients who receive CCAP interventions

  22. Out-of-pocket costs 2 [Parent trial]

    Time frame: 12 months post randomisation

    Out-of-pocket costs for receiving CCAP interventions (e.g.: time loss, travel, etc) using survey form for receiving the CCAP interventions to patients who receive CCAP interventions

  23. Disability [Parent trial]

    Time frame: 3 months post randomisation

    Standardised disability scores used to estimate Quality-Adjusted Life Years (QALYs) using the WHO Disability Assessment Scale (WHODAS)

  24. Disability [Parent trial]

    Time frame: 6 months post randomisation

    Standardised disability scores used to estimate Quality-Adjusted Life Years (QALYs) using the WHO Disability Assessment Scale (WHODAS)

  25. Disability [Parent trial]

    Time frame: 12 months post randomisation

    Standardised disability scores used to estimate Quality-Adjusted Life Years (QALYs) using the WHO Disability Assessment Scale (WHODAS)

  26. Pattern of drinking [Sub-group A Hazardous drinking]

    Time frame: 6 months post randomisation

    Number of heavy drinking days in the past two weeks measured using the TLFB

  27. Pattern of drinking [Sub-group A Hazardous drinking]

    Time frame: 12 months post randomisation

    Number of heavy drinking days in the past two weeks measured using the TLFB

  28. Intensity of drinking [Sub-group A Hazardous drinking]

    Time frame: 3 months post randomisation

    Grams ethanol consumed per drinking day in past two weeks measured using the TLFB

  29. Intensity of drinking [Sub-group A Hazardous drinking]

    Time frame: 6 months post randomisation

    Grams ethanol consumed per drinking day in past two weeks measured using the TLFB

  30. Intensity of drinking [Sub-group A Hazardous drinking]

    Time frame: 12 months post randomisation

    Grams ethanol consumed per drinking day in past two weeks measured using the TLFB

  31. Remission [Sub-group A Hazardous drinking]

    Time frame: 3 months post randomisation

    Alcohol Use Disorder Identification Test (AUDIT) score <8

  32. Remission [Sub-group A Hazardous drinking]

    Time frame: 6 months post randomisation

    Alcohol Use Disorder Identification Test (AUDIT) score <8

  33. Remission [Sub-group A Hazardous drinking]

    Time frame: 12 months post randomisation

    Alcohol Use Disorder Identification Test (AUDIT) score <8

  34. Percentage days abstinent (PDA) [Sub-group A Hazardous drinking]

    Time frame: 3 months post randomisation

    Proportion of days abstinent in the past two weeks measured using the TLFB

  35. Percentage days abstinent (PDA) [Sub-group A Hazardous drinking]

    Time frame: 6 months post randomisation

    Proportion of days abstinent in the past two weeks measured using the TLFB

  36. Percentage days abstinent (PDA) [Sub-group A Hazardous drinking]

    Time frame: 12 months post randomisation

    Proportion of days abstinent in the past two weeks measured using the TLFB

  37. Pattern of drinking [Sub-group A Hazardous drinking]

    Time frame: 3 months post randomisation

    Percentage days heavy drinking (PDHD) in the past two weeks measured using the TLFB

  38. Pattern of drinking [Sub-group A Hazardous drinking]

    Time frame: 6 months post randomisation

    Percentage days heavy drinking (PDHD) in the past two weeks measured using the TLFB

  39. Pattern of drinking [Sub-group A Hazardous drinking]

    Time frame: 12 months post randomisation

    Percentage days heavy drinking (PDHD) in the past two weeks measured using the TLFB

  40. Treatment entry [Sub-group B Harmful drinking]

    Time frame: 3 months post randomisation

    Proportion of consented participants who receive at least one session of counselling

  41. Treatment entry [Sub-group B Harmful drinking]

    Time frame: 6 months post randomisation

    Proportion of consented participants who receive at least one session of counselling

  42. Treatment entry [Sub-group B Harmful drinking]

    Time frame: 12 months post randomisation

    Proportion of consented participants who receive at least one session of counselling

  43. Percentage days abstinent (PDA) [Sub-group B Harmful drinking]

    Time frame: 3 months post randomisation

    Proportion of days abstinent in the past two weeks measured using the TLFB

  44. Percentage days abstinent (PDA) [Sub-group B Harmful drinking]

    Time frame: 6 months post randomisation

    Proportion of days abstinent in the past two weeks measured using the TLFB

  45. Percentage days abstinent (PDA) [Sub-group B Harmful drinking]

    Time frame: 12 months post randomisation

    Proportion of days abstinent in the past two weeks measured using the TLFB

  46. Pattern of drinking [Sub-group B Harmful drinking]

    Time frame: 3 months post randomisation

    Percentage days heavy drinking (PDHD) in the past two weeks measured using the TLFB

  47. Pattern of drinking [Sub-group B Harmful drinking]

    Time frame: 6 months post randomisation

    Percentage days heavy drinking (PDHD) in the past two weeks measured using the TLFB

  48. Pattern of drinking [Sub-group B Harmful drinking]

    Time frame: 12 months post randomisation

    Percentage days heavy drinking (PDHD) in the past two weeks measured using the TLFB

  49. Intensity of drinking [Sub-group B Harmful drinking]

    Time frame: 3 months post randomisation

    Grams ethanol consumed per drinking day in past two weeks measured using the TLFB

  50. Intensity of drinking [Sub-group B Harmful drinking]

    Time frame: 6 months post randomisation

    Grams ethanol consumed per drinking day in past two weeks measured using the TLFB

  51. Intensity of drinking [Sub-group B Harmful drinking]

    Time frame: 12 months post randomisation

    Grams ethanol consumed per drinking day in past two weeks measured using the TLFB

  52. Remission [Sub-group B Harmful drinking]

    Time frame: 3 months post randomisation

    Alcohol Use Disorder Identification Test (AUDIT) score <8

  53. Remission [Sub-group B Harmful drinking]

    Time frame: 6 months post randomisation

    Alcohol Use Disorder Identification Test (AUDIT) score <8

  54. Remission [Sub-group B Harmful drinking]

    Time frame: 12 months post randomisation

    Alcohol Use Disorder Identification Test (AUDIT) score <8

  55. Consequences of alcohol use [Sub-group B Harmful drinking]

    Time frame: 3 months post randomisation

    Physical, social, intrapersonal and interpersonal consequences of alcohol use measured using the Short Inventory of Problems (SIP)

  56. Consequences of alcohol use [Sub-group B Harmful drinking]

    Time frame: 6 months post randomisation

    Physical, social, intrapersonal and interpersonal consequences of alcohol use measured using the Short Inventory of Problems (SIP)

  57. Consequences of alcohol use [Sub-group B Harmful drinking]

    Time frame: 12 months post randomisation

    Physical, social, intrapersonal and interpersonal consequences of alcohol use measured using the Short Inventory of Problems (SIP)

  58. Food security [Sub-group B Harmful drinking]

    Time frame: 12 months post randomisation

    Improvement of food security as measured using Food Insecurity Experience Scale

  59. Intensity of drinking [Sub-group C Dependent drinking]

    Time frame: 6 months post randomisation

    Units of alcohol consumed in the past week measured using TLFB

  60. Intensity of drinking [Sub-group C Dependent drinking]

    Time frame: 12 months post randomisation

    Units of alcohol consumed in the past week measured using TLFB

  61. Consequences of alcohol use [Sub-group C Dependent drinking]

    Time frame: 3 months post randomisation

    Physical, social, intrapersonal and interpersonal consequences of alcohol use measured using the Short Inventory of Problems (SIP)

  62. Consequences of alcohol use [Sub-group C Dependent drinking]

    Time frame: 6 months post randomisation

    Physical, social, intrapersonal and interpersonal consequences of alcohol use measured using the Short Inventory of Problems (SIP)

  63. Consequences of alcohol use [Sub-group C Dependent drinking]

    Time frame: 12 months post randomisation

    Physical, social, intrapersonal and interpersonal consequences of alcohol use measured using the Short Inventory of Problems (SIP)

  64. Food security [Sub-group C Dependent drinking]

    Time frame: 12 months post randomisation

    Improvement of food security as measured using Food Insecurity Experience Scale

  65. Remission [Sub-group C Dependent drinking]

    Time frame: 3 months post randomisation

    Alcohol Use Disorder Identification Test (AUDIT) score <8

  66. Remission [Sub-group C Dependent drinking]

    Time frame: 6 months post randomisation

    Alcohol Use Disorder Identification Test (AUDIT) score <8

  67. Remission [Sub-group C Dependent drinking]

    Time frame: 12 months post randomisation

    Alcohol Use Disorder Identification Test (AUDIT) score <8

  68. Treatment entry [Sub-group C Dependent drinking]

    Time frame: Through the period of intervention delivery, an average of 3 months

    Proportion of consented participants who receive at least one session of counselling

  69. Treatment completion [Sub-group C Dependent drinking]

    Time frame: Through the period of intervention delivery, an average of 3 months

    Proportion of consented participants who go on to complete treatment defined as planned discharge which would be one of the following

    • Received all sessions as per protocol
    • Discharge by mutual agreement between NSHW and participant on achievement of treatment goals
    • Referral out of the program

Study contacts

Contact information is provided by the study sponsor or research team.

Abhijit Nadkarni

CONTACT

[email protected]

+91 7887872345

Urvita Bhatia

CONTACT

[email protected]

+91 7887872345

Sponsors and collaborators

Lead sponsor

Sangath

Other

Collaborators

  • London School of Hygiene and Tropical Medicine

Registry information

Official study title

Coordinated Care for Alcohol Problems (CCAP): a Randomised Controlled Trial From Goa, India

Acronym: CCAP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 3, 2025
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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