Clinical Trials Logo

Clinical Trial Summary

The aim of the present study is to test the feasibility of therapist-guided Internet treatment for hazardous (risky) and harmful alcohol use among adults 18 years and older. The hypothesis is that the intervention is feasible and that it can help people change risky drinking habits at an early stage before developing into problems that are more serious.The therapist-guided Internet treatment addresses the person's need for confidentiality and contributes to reducing the stigma associated with visiting a substance abuse clinic.


Clinical Trial Description

Background: A significant proportion of people with substance abuse do not seek help for their problems and therefore do not receive the necessary help at an early stage. An important reason for this is the stigma associated with substance abuse. Therapist-guided Internet treatment has been developed and tested in recent years as an approach that increases access to effective treatment for a variety of mental and substance-related problems and disorders. Internet-based interventions increase the patient's choice of type of treatment and give the patient an experience of having control over their own behavior change. Moreover, such treatment is independent of where you live, and you do not need to attend a clinic. In addition, by offering therapist-guided Internet treatment, therapists can treat far more patients compared to regular face-to-face treatment. In this way, the health services, which are already under severe pressure due to many new and competing tasks, are relieved. Research questions: 1. Is therapist-guided Internet treatment for hazardous and harmful alcohol use feasible for self-referred persons? 2. What factors contribute/do not contribute to the feasibility of treatment? 3. Can the intervention help people change risky drinking habits before it develops into problems that are more serious? 4. How do participants experience the intervention? Methods: Participants: A total of 30 participants will be recruited through announcements in social media, newspapers and through GP's and other health care services. Participants will be recruited from the catchment area of Haukeland University Hospital, Western Norway, and Vestfold Hospital, Eastern Norway. Design: The study will be conducted as an open, 6-months follow-up study, to assess whether the design is suitable for a randomized controlled trial in the next round. Both quantitative and qualitative methods will be used to investigate the feasibility of the treatment program. Data collection: Assessments will be carried out at start of treatment (T1), through the treatment course (T2) and at the end of treatment (T3) and at follow-up (T4). Qualitative interviews will be conducted at the end of treatment. Intervention: The treatment program is developed at Vestfold Hospital, Norway. It is based on Internet- based cognitive behavior therapy (ICBT). The treatment program consists of eight text-based self-help modules on the Internet that participants can access via secure login using Bank identification (ID) (security level 4). The self-help modules include psychoeducation, tasks and exercises. The therapist guidance is secondary to the self-help modules. The therapist provides feedback to the patient online in the secured program once a week. Statistics: Sample size: Since this is a feasibility study primarily intended to test the feasibility of therapist-guided Internet treatment for hazardous and harmful alcohol use, the sample will be limited to 30 participants. Therefore, power analysis is not performed. Statistical methods: Both statistical and interpretative methods will be used. Descriptive statistics (percentages, means, standard deviations), as well as statistical and clinical change. Qualitative in-depth interviews will be analyzed using thematic content analysis. Plan for activities and dissemination: Scheduled start of data collection is September 2020. The data collection will continue until the summer of 2021. The follow-up period will be completed by the end of 2021. The results of the feasibility study will be published in peer-reviewed journals. Furthermore, the results will be disseminated to the public through media (including social media), and as information aimed at both health and social care professionals, patient groups and user forums. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04544930
Study type Interventional
Source Haukeland University Hospital
Contact
Status Completed
Phase N/A
Start date September 15, 2020
Completion date November 30, 2021

See also
  Status Clinical Trial Phase
Completed NCT03165942 - Neuroendocrine Response to Oral Alcohol Administration Phase 1
Recruiting NCT05343039 - Technology Enhanced Adolescent Mental Health (TEAM) N/A
Active, not recruiting NCT04070521 - EEG Monitoring in the Emergency Department
Completed NCT03169244 - Buproprion for Binge Drinking Phase 2
Recruiting NCT05246202 - Personalized Feedback Intervention for Latinx Drinkers With Anxiety N/A
Completed NCT05036499 - PFI for Pain-Related Anxiety Among Hazardous Drinkers With Chronic Pain N/A
Recruiting NCT04368416 - Anxiety/Depression, Sleep and Alcohol in Elderly Anxiety/Depression, Sleep Disturbances and Alcohol Use Disorder in Elderly With Cognitive Complaints
Not yet recruiting NCT04557631 - Evaluation of the Threshold for the Interpretation of the Results of a Method for the Blood Determination of Phosphatidyléthanol
Terminated NCT00890149 - Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults Phase 2
Completed NCT02179749 - Mifepristone Treatment of Alcohol Use Disorder Phase 2
Completed NCT02448134 - A Community-Based Strategy for Preventing Underage Drinking N/A
Completed NCT02681406 - Smartphone Based Continuing Care for Alcohol N/A
Withdrawn NCT01796158 - Pilot Test of Computerized MET to Reduce Adolescent Alcohol Use N/A
Withdrawn NCT01847300 - cSBI-M for Young Military Personnel N/A
Terminated NCT01408641 - Topiramate for Alcohol Use in Posttraumatic Stress Disorder N/A
Completed NCT01553136 - Varenicline Treatment of Alcohol Dependence in Smokers Phase 2
Withdrawn NCT01511679 - Brain-imaging and Adolescent Neuroscience Consortium N/A
Withdrawn NCT01275391 - cSBIRT to Reduce Teen Tobacco, Alcohol and Drug Use Phase 1/Phase 2
Active, not recruiting NCT01539525 - Screening to Augment Referral to Treatment- Project START Phase 2
Completed NCT01207258 - Brief Intervention for Problem Drinking and Partner Violence Phase 2