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Randomised controlled feasibility trial of a web-based alcohol treatment programme

Randomised controlled feasibility trial of a web-based intervention to reduce consumption in people with 'hazardous and harmful' alcohol intake compared with a face-to-face intervention

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN31789096
Enrollment
200
Registered
2014-04-16
Start date
2014-03-03
Completion date
Unknown
Last updated
2018-07-16

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

Conditions

Hazardous or harmful alcohol use Mental and Behavioural Disorders

Interventions

Potential participants will be patients referred or self-referred to participating community alcohol services. They will attend the CAS for their first assessment appointment with an alcohol counsello

Sponsors

University College London (UCL)/Royal Free London NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Participants will be hazardous and harmful drinkers in north London, identified using a validated screening tool such as AUDIT, referred from primary care, secondary care, or self-referred, to CAS. 2. Patients aged 18 or over at time of screening 3. Diagnosis of an alcohol use disorder using AUDIT criteria (score 8 or over) 4. Residing in a stable place of residence 5. Providing informed consent for randomisation, treatment and follow-up 6. Patients without prior internet experience, or without home access to the internet will be included, but will be offered additional training as part of their facilitated access to DYD. All participants will be given information about local free or low-cost public internet access points, such as libraries, health centres and cluster rooms.

Exclusion criteria

Exclusion criteria: 1. Patients undergoing treatment for substance use or primary drug dependence (excluding nicotine) in the past 90 days 2. Already receiving help for an alcohol use disorder 3. Outstanding legal issues likely to lead to imprisonment 4. Severe mental or physical illness likely to preclude active participation in treatment or follow-up 5. Severe physical dependency on alcohol (LDQ > 20) 6. Unable to consult in English without an interpreter 7. Pregnancy 8. Patients with severe physical dependency or severe and complex co-existing physical or mental health problems will be referred for Tier 4 services in line with DH guidelines 9. Patients at risk of high risk of self-harm or suicide will not be excluded, but will be referred back to their GP for additional help

Design outcomes

Primary

MeasureTime frame
Current primary outcome measures as of 20/06/2018: 1. Recruitment as a percentage of eligible patients 2. Retention, measured by completeness of online data collection at 3 months as a percentage of patients randomised Previous primary outcome measures: The outcomes examined at three months and 12 months will be: 1. Recruitment 2. Study attrition 3. Change in unit consumption of alcohol per week (using TOT-AL, an online beverage-specific measure which requires participants to enter the type and quantity of alcohol drinks consumed on each day of the past week)

Secondary

MeasureTime frame
Current secondary outcome measures as of 20/06/2018: 1. Average alcohol intake in units measured using TOT-AL, an online beverage-specific measure, at baseline, 1 and 3 months 2. Problem drinking assessed using AUDIT at baseline and 3 months 3. Psychological distress assessed using CORE-10 at baseline and 3 months 4. Confidence in avoiding alcohol assessed using SCQ-8 at baseline and 3 months 5. Satisfaction with care assessed using CSQ-8 at 3 months 6. Adherence to the intervention (for those randomised to this arm), measured through automated recording of numbers of log-ins and numbers of pages visited at each log-in, at 3 months 7. Other sources of support accessed during treatment, measured using a drop down menu of options: group therapy; horticulture; acupuncture; art therapy; other therapies (participant to state in free text); at 1 and 3 months Previous secondary outcome measures: 1. Demographic and clinical characteristics will be recorded at baseline, which will enable us to determine if there are inequalities in access to the online alcohol programme Secondary outcomes examined at three months and 12 months will be: 2. Change in participant satisfaction with care (measured using the 8-item Client Satisfaction Questionnaire (CSQ-8) 3. Change in Hospital Anxiety and Depression scale 4. Change in well-being scores (using EQ-5D) 5. Health professional time (a proforma will be used to record health professional time in minutes taken in both interventions, including failed encounters)

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 15, 2026