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Not yet recruitingNCT07260149CCAPUpdated Apr 22, 2026

Coordinated Care for Alcohol Problems

An interventional study of CCAP and Enhanced usual care in Alcohol Use Disorder, sponsored by Sangath. Not yet recruiting. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by Sangath · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
1,022
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study summary

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).

02

Conditions studied

  • Alcohol Use Disorder

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Keywords

  • Alcohol use disorder
  • Coordinated care
  • Complex intervention
  • Digital intervention
  • Psychosocial intervention
  • Non-specialist health workers
  • Task-sharing
  • Randomised controlled trial
  • India
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  1. Scoring positive for problem drinking (≥ 8 on the AUDIT)
  2. 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.

  3. Language:

    1. 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.
    2. 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.
  4. For hazardous drinking, patients must also have access to a personal smartphone with WhatsApp.
  5. 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

Exclusion Criteria:

  1. For hazardous drinking, patients with significant visual or hearing impairment will be ineligible due to the audio-visual nature of the intervention.
  2. 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'.
  3. 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.
  4. Those who are alcohol dependent and do not meet the eligibility criteria for home detoxification as per protocol.
  5. 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).
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
1,022 participants (estimated)

Study arms

  • Experimental
    CCAP

    Hazardous drinking: M-BIT is an eight-week digital intervention delivered over WhatsApp. Harmful drinking: CAP is a manualised brief psychological treatment for harmful drinking. CAP+ will include treatment engagement strategies integrated into CAP. Dependent drinking: CONTAD is a manualised treatment comprising of 5-7 days of supervised home detoxification followed by relapse prevention counselling for dependent drinking. Participants with harmful and dependent drinking level will be offered referral to the public District Hospitals or the state Psychiatric Hospital for assessment of eligibility for anti-craving medicines if available and to be prescribed and dispensed as per their Standard Operating Procedures.

    Behavioral: CCAP

  • Active comparator
    Enhanced usual care

    Hazardous drinking: Brief intervention leaflet which is an information sheet/brochure with information on alcohol consumption, associated risks, and tips to manage and reduce drinking. Harmful drinking: CAP is a manualised brief psychological treatment for harmful drinking. It 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 has proven to be effective and cost-effective in reducing drinking in men with harmful level of drinking in a prior study. CAP can be delivered in any of the local vernacular (Hindi, Marathi, Konkani) or English. Dependent drinking: Supported in-patient detoxification which is hospital-based detoxification delivered in secondary or tertiary care.

    Behavioral: Enhanced usual care

Interventions

  • BehavioralCCAP

    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.

  • BehavioralEnhanced usual care

    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.

05

What researchers measure

Primary outcomes

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

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

    Time frame: 3 months post randomisation

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

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

    Time frame: 3 months post randomisation

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

    Proportion of consented participants who go on to complete treatment defined as planned discharge which would be one of the following 1. Received all sessions as per protocol 2. Discharge by mutual agreement between NSHW and participant on achievement of treatment goals 3. Referral out of the study

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

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

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

    Time frame: 3 months post randomisation

Secondary outcomes

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

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

    Time frame: 6 months post randomisation

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

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

    Time frame: 12 months post randomisation

  3. Consequences of alcohol use [Parent trial]

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

    Time frame: 3 months post randomisation

  4. Consequences of alcohol use [Parent trial]

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

    Time frame: 6 months post randomisation

  5. Consequences of alcohol use [Parent trial]

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

    Time frame: 12 months post randomisation

  6. Food security [Parent trial]

    Improvement of food security as measured using Food Insecurity Experience Scale

    Time frame: 12 months post randomisation

  7. Pattern of drinking [Parent trial]

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

    Time frame: 3 months post randomisation

  8. Pattern of drinking [Parent trial]

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

    Time frame: 6 months post randomisation

  9. Pattern of drinking [Parent trial]

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

    Time frame: 12 months post randomisation

  10. Intensity of drinking [Parent trial]

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

    Time frame: 3 months post randomisation

  11. Intensity of drinking [Parent trial]

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

    Time frame: 6 months post randomisation

  12. Intensity of drinking [Parent trial]

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

    Time frame: 12 months post randomisation

  13. Remission [Parent trial]

    Alcohol Use Disorder Identification Test (AUDIT) score \<8

    Time frame: 3 months post randomisation

  14. Remission [Parent trial]

    Alcohol Use Disorder Identification Test (AUDIT) score \<8

    Time frame: 6 months post randomisation

  15. Remission [Parent trial]

    Alcohol Use Disorder Identification Test (AUDIT) score \<8

    Time frame: 12 months post randomisation

  16. System-level costs [Parent trial]

    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)

    Time frame: Monthly, during the period of implementation

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

    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

    Time frame: 3 months post randomisation

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

    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

    Time frame: 6 months post randomisation

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

    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

    Time frame: 12 months post randomisation

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

    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

    Time frame: 3 months post randomisation

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

    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

    Time frame: 6 months post randomisation

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

    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

    Time frame: 12 months post randomisation

  23. Disability [Parent trial]

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

    Time frame: 3 months post randomisation

  24. Disability [Parent trial]

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

    Time frame: 6 months post randomisation

  25. Disability [Parent trial]

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

    Time frame: 12 months post randomisation

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

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

    Time frame: 6 months post randomisation

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

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

    Time frame: 12 months post randomisation

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

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

    Time frame: 3 months post randomisation

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

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

    Time frame: 6 months post randomisation

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

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

    Time frame: 12 months post randomisation

  31. Remission [Sub-group A Hazardous drinking]

    Alcohol Use Disorder Identification Test (AUDIT) score \<8

    Time frame: 3 months post randomisation

  32. Remission [Sub-group A Hazardous drinking]

    Alcohol Use Disorder Identification Test (AUDIT) score \<8

    Time frame: 6 months post randomisation

  33. Remission [Sub-group A Hazardous drinking]

    Alcohol Use Disorder Identification Test (AUDIT) score \<8

    Time frame: 12 months post randomisation

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

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

    Time frame: 3 months post randomisation

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

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

    Time frame: 6 months post randomisation

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

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

    Time frame: 12 months post randomisation

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

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

    Time frame: 3 months post randomisation

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

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

    Time frame: 6 months post randomisation

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

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

    Time frame: 12 months post randomisation

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

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

    Time frame: 3 months post randomisation

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

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

    Time frame: 6 months post randomisation

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

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

    Time frame: 12 months post randomisation

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

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

    Time frame: 3 months post randomisation

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

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

    Time frame: 6 months post randomisation

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

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

    Time frame: 12 months post randomisation

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

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

    Time frame: 3 months post randomisation

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

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

    Time frame: 6 months post randomisation

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

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

    Time frame: 12 months post randomisation

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

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

    Time frame: 3 months post randomisation

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

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

    Time frame: 6 months post randomisation

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

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

    Time frame: 12 months post randomisation

  52. Remission [Sub-group B Harmful drinking]

    Alcohol Use Disorder Identification Test (AUDIT) score \<8

    Time frame: 3 months post randomisation

  53. Remission [Sub-group B Harmful drinking]

    Alcohol Use Disorder Identification Test (AUDIT) score \<8

    Time frame: 6 months post randomisation

  54. Remission [Sub-group B Harmful drinking]

    Alcohol Use Disorder Identification Test (AUDIT) score \<8

    Time frame: 12 months post randomisation

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

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

    Time frame: 3 months post randomisation

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

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

    Time frame: 6 months post randomisation

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

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

    Time frame: 12 months post randomisation

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

    Improvement of food security as measured using Food Insecurity Experience Scale

    Time frame: 12 months post randomisation

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

    Units of alcohol consumed in the past week measured using TLFB

    Time frame: 6 months post randomisation

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

    Units of alcohol consumed in the past week measured using TLFB

    Time frame: 12 months post randomisation

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

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

    Time frame: 3 months post randomisation

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

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

    Time frame: 6 months post randomisation

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

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

    Time frame: 12 months post randomisation

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

    Improvement of food security as measured using Food Insecurity Experience Scale

    Time frame: 12 months post randomisation

  65. Remission [Sub-group C Dependent drinking]

    Alcohol Use Disorder Identification Test (AUDIT) score \<8

    Time frame: 3 months post randomisation

  66. Remission [Sub-group C Dependent drinking]

    Alcohol Use Disorder Identification Test (AUDIT) score \<8

    Time frame: 6 months post randomisation

  67. Remission [Sub-group C Dependent drinking]

    Alcohol Use Disorder Identification Test (AUDIT) score \<8

    Time frame: 12 months post randomisation

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

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

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

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

    Proportion of consented participants who go on to complete treatment defined as planned discharge which would be one of the following 1. Received all sessions as per protocol 2. Discharge by mutual agreement between NSHW and participant on achievement of treatment goals 3. Referral out of the program

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

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07260149
Lead sponsor
Sangath
Collaborators
London School of Hygiene and Tropical Medicine
Responsible party
Sponsor
First posted
Dec 3, 2025
Start date
Jun 1, 2026 (estimated)
Primary completion
Mar 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Apr 22, 2026

Study contacts

Abhijit Nadkarni
Contact
abhijit.nadkarni@lshtm.ac.uk
+91 7887872345
Urvita Bhatia
Contact
urvita.bhatia@lshtm.ac.uk
+91 7887872345

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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