| - candidate number | 2562 |
| - NTR Number | NTR960 |
| - ISRCTN | ISRCTN wordt niet meer aangevraagd |
| - Date ISRCTN created | |
| - date ISRCTN requested | |
| - Date Registered NTR | 20-apr-2007 |
| - Secondary IDs | |
| - Public Title | Drinking Less, Self help for Problem Drinking: randomised clinical trial. |
| - Scientific Title | Self help for Problem Drinking: pragmatic randomised clinical trial. |
| - ACRONYM | N/A |
| - hypothesis | To test the effectiveness of a self help booklet without therapist guidance vis-à-vis a psycho-education brochure for adult problem drinkers in the general population. |
| - Healt Condition(s) or Problem(s) studied | Alcohol abuse, Cognitive behavior therapy, Self help, Problem drinking |
| - Inclusion criteria | 1. a. Men drinking either more than 21 units per week (excessive drinking) or more than 6 units at least one day per week for the past three months (hazardous drinking); b. Women drinking over 14 units a week or more than 4 units at least one day a week for the past three months. One unit represents 10 g of ethanol; 2. Age 18 to 65; 3. Given informed consent. |
| - Exclusion criteria | 1. Receiving professional help for problem drinking in the 12 months period before the start of the study; 2. Not available for follow up; 3. Participation in a study with a conflicting interest. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-jun-2001 |
| - planned closingdate | 31-mrt-2003 |
| - Target number of participants | 175 |
| - Interventions | Experimental condition: The self help book “How to moderate your drinking?” (Hoe minder te drinken; Van Emst 1997)? This self help book is based on cognitive behavioural and self control principles. The book aims to support problem drinkers in their effort to decrease their alcohol consumption. The booklet consists of information on sensible and risky drinking patterns, alcohol monitoring diary and tips and exercises for maintaining reduced alcohol consumption and coping with relapse. The recommended treatment period is 6 weeks. Control condition: A psycho-educational brochure on the effects of alcohol use. |
| - Primary outcome | Problem drinking, defined as alcohol consumption exceeding the guideline – 21 or 14 standard units (m/f) average per week or 6 or 4 units (m/f) at least one day per week over the previous three months. |
| - Secondary outcome | Mean weekly alcohol consumption in terms of a continuous measure over the past three months. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | Drs. H. Riper |
| - CONTACT for SCIENTIFIC QUERIES | Drs. H. Riper |
| - Sponsor/Initiator | Trimbos-institute - Netherlands Institute of Mental Health and Addiction |
| - Funding (Source(s) of Monetary or Material Support) | Ministery of Health and Social Affairs |
| - Publications | N/A |
| - Brief summary | The experimental condition decreased it's alcohol consumption over the past three months to a significant higher degree than the control condition six months after the start of the intervention. |
| - Main changes (audit trail) | |
| - RECORD | 20-apr-2007 - 4-jun-2008 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl