Testing the effectiveness of two web-based interventions aiming to reduce alcohol consumption
| ISRCTN | ISRCTN10323951 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10323951 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/09/2015
- Registration date
- 08/09/2015
- Last edited
- 09/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Misuse of alcohol and alcohol dependence are a growing problem worldwide. Many people show signs of drinking too much alcohol, or drinking alcohol at inappropriate times (hazardous alcohol use), and are at risk of developing alcohol dependence, often known as “alcoholism”. There is a great deal of evidence suggesting that drinking too much alcohol can lead to mental illnesses such as depression. Providing an inexpensive self-help programme using the internet to prevent people from developing full alcohol-dependence could be very beneficial from a public health point of view. Additionally, this programme could be used to help treat the feelings of depression that often accompany alcohol misuse. The aim of this study is find out whether the use of a web-based self-help programme for hazardous alcohol users with mild to moderate depression can help to reduce alcohol intake and alleviate symptoms of depression.
Who can participate?
Adults who are hazardous alcohol users with mild to moderate feelings of depression.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in the first group (intervention group) are started on a 6 week self-help programme focusing on alcohol use via the internet. This programme provides education materials as well as teaching self-control practices and techniques to reduce cravings. The participants are asked to keep a diary throughout the 6 week intervention, in order to study their thoughts on the programme and see how well the treatment is working. Those in the second group (control group) are put on a waiting list. After 6 months on the waiting list, those in the control group are given the opportunity to start the online self-help programme. For both groups, at the start of the study, at three months and at six months, alcohol consumption is measured, as well as mental health issues (such as depression). The cost-effectiveness of the programme is also measured at these time points.
What are the possible benefits and risks of participating?
Benefits of participating include a better understanding of addictive behaviour and being given tools to help handle cravings, reducing the risk of alcohol dependency. Additionally, for participants in the alcohol and depression group, their feelings of depression may be reduced. Potential risks of participating are insignificant, however withdrawal symptoms, such as cravings, may be experienced.
Where is the study run from?
1. Swiss Research Institute for Public Health and Addiction (Switzerland)
2. Leuphana University (Germany)
3. Arkin Mental Health Care (Netherlands)
4. Amsterdam Institute for Addiction Research (Netherlands)
5. VU University of Amsterdam (Netherlands)
When is the study starting and how long is it expected to run for?
November 2015 to January 2018
Who is funding the study?
Swiss Foundation for Alcohol Research (Switzerland)
Who is the main contact?
Dr Michael Schaub
Contact information
Scientific
Konradstrasse 32
Postfach
CH-8031 Zürich
Zürich
8031
Switzerland
Study information
| Study design | Randomized controlled trial with web-based psychological intervention |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Web-based Dual Disorder Treatment Trial among Problematic Alcohol Users with Moderate Depression Symptoms |
| Study objectives | The objective will be to test the effectiveness of a web-based intervention aiming to reduce alcohol consumption and depression symptoms combined, a web-based self-help intervention focusing on problematic alcohol use only, and a waiting list control condition in hazardous and harmful alcohol users with co-morbid mild to moderate depression symptoms. We will test the following detailed study hypotheses with respect to the reduction of the quantity of weekly standard drinks and depression symptoms between the baseline and the 3 and 6 months follow-up: 1. Tailored self-help for the reduction of alcohol use and depression symptoms (study arm 1) is more effective than the waiting list control condition (study arm 3) in reducing alcohol use and depression symptoms. 2. Tailored self-help for the reduction of alcohol use (study arm 2) is more effective than the waiting list control condition (study arm 3) in reducing alcohol use but not depression symptoms. 3. Tailored self-help for the reduction of alcohol use and depression symptoms (study arm 1) is more effective than self-help for the reduction of alcohol use only (study arm 2) in the reduction of depression symptoms but not in the reduction of alcohol use. |
| Ethics approval(s) | Ethics Committee of the Canton of Zurich, 07/04/2015, ref: KEK-ZH-Nr: 2015-0082 |
| Health condition(s) or problem(s) studied | 1. Harmful or hazardous alcohol users 2. Mild to moderate co-occurring depression symptoms |
| Intervention | After ensuring that potential participants are eligible for the study (i.e., after a baseline assessment), they will be randomized by a computer program to 1 of 3 parallel groups: 1. Experimental Intervention 1: Web-based self-help program focusing on alcohol and depression; 2. Experimental Intervention 2: Web-based self-help program focusing on alcohol; and 3. Control Condition: waiting list. Both web-based self-help interventions (study arms 1 and 2) consist of a diary and several (currently 8) modules based on the principles of motivational interviewing, self-control practices, and methods of cognitive behavioural therapy. Participants can study all modules at their own pace and in their own order, though a specific order will be advised. For the alcohol-only group, the diary will assess the daily alcohol consumption. For the alcohol and depression group, the diary will assess the daily alcohol consumption, mood and positive activities. Both web-based self-help interventions consist of a 6-week program starting individually at the point of the user's online registration. Follow-ups will be assessed 3 and 6 month after the individual’s self-chosen starting point. The control condition is a waiting-list. The follow-ups are timed as in the experimental interventions (after 3 and 6 months). After 6 months the study phase of the control condition is finished and people will be given the opportunity to start the self-help programme of experimental condition 1. |
| Intervention type | Behavioural |
| Primary outcome measure | The number of weekly standard drinks will be assessed with timeline follow-back (TLFB) at baseline, 3 months and 6 months. |
| Secondary outcome measures | 1. Depressive symptoms assessed with the "Center of Epidemiologic Studies of Depression" (CES-D-20) at baseline, 3 months and 6 months 2. Use of tobacco and illicit drugs assessed with the "Fragebogen Substanzanamnese" questionnaire (FDA) at baseline, 3 months and 6 months 3. Changes in mental health symptoms assessed with the Mental Health Inventory questionnaire (MHI-5) at baseline, 3 months and 6 months 4. Treatment retention measured by using the diary every week over the 6-weeks of intervention 5. Cost-effectiveness-analyses assessed with the EuroQol Quality of Life questionnaire (EQ-5D-3L) at baseline, 3 months and 6 months 6. Cost-utility-analysis and client intervention satisfaction assessed with the Questionnaire on healthcare utilization and productivity losses (TiC-P) at baseline, 3 months and 6 months 7. The "Customer Satisfaction Questionnaire" (CSQ-8) is used as secondary outcome only for participants who have received web-based self-help intervention for 6 weeks (i.e., not used for the control group) measured every week over the 6-weeks of intervention 8. Drinking behaviour is determined using the total score of the short version of the Alcohol Use Disorders Identification Test (AUDIT-C) at baseline, 3 months and 6 months |
| Overall study start date | 01/11/2015 |
| Completion date | 31/01/2018 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 756 (3 groups à 252) |
| Total final enrolment | 689 |
| Key inclusion criteria | 1. Age 18 years or over 2. AUDIT score ≥ 8 and ≤ 20 (AUDIT = Alcohol Use Disorder Inventory Test) 3. CES-D-20 score greater than 16 (Center of Epidemiological Studies of Depression) 4. Weekly Internet Access |
| Key exclusion criteria | 1. Participation in other psycho-social or pharmacological treatments for the reduction/cessation of alcohol use or the reduction of depression symptoms 2. Use of opioids or stimulants in the last 12 months and/or cannabis use of more than once a week in the previous 30 days 3. Previous treatment for cardiovascular problems 4. Suicidal ideation or plans in the last 12 months 5. Pregnancy or breast feeding (female participants only) |
| Date of first enrolment | 01/11/2015 |
| Date of final enrolment | 31/07/2017 |
Locations
Countries of recruitment
- Germany
- Netherlands
- Switzerland
Study participating centres
Zurich
8031
Switzerland
Lüneburg
21335
Germany
Amsterdam
1033
Netherlands
Amsterdam
1105
Netherlands
Amsterdam
1081
Netherlands
Sponsor information
Government
Elisabeth Domenge-Vieu
P.O.Box 870
Lausanne
1001
Switzerland
| Website | http://www.alcoholresearch.ch/en/1.html |
|---|
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Not provided at time of registration. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 25/05/2016 | Yes | No | |
| Results article | 01/08/2021 | 09/09/2021 | Yes | No |
Editorial Notes
09/09/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
31/05/2016: Publication reference added.
01/12/2015: the original primary outcome measure (Drinking behaviour is determined using the total score of the short version of the Alcohol Use Disorders Identification Test (AUDIT-C) at baseline, 3 months and 6 months) has been changed to a secondary outcome measure. A new primary outcome measure has been added to the record.
