Effectiveness and Costs of Internet-based Treatment for Harmful Alcohol Use and Face-to-face Treatment in Addiction Care

Alcohol Use Disorders Clinical Trial

Official title:

Comparing Effectiveness and Costs of Internet-based Treatment for Problematic Alcohol Use and Face-to-face Treatment in Addiction Care: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02671019
• Other study ID #: 2014/1758-31/2
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2015
• Est. completion date: December 2019

Study information

• Verified date: May 2019
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to compare the effectiveness and costs of a five-module Internet-based treatment program (including therapist support) for harmful alcohol use with the effectiveness and cost of the same treatment content delivered face-to-face in specialized addiction treatment. The hypotheses to be tested through this trial are that:

1. The Internet-based treatment program (including therapist support) is as effective (reducing alcohol consumption) as the same treatment content delivered face-to-face in specialized addiction treatment.

2. The Internet-based treatment program (including therapist support) is associated with lower cost per treated individual in relation to the achieved effects (in terms of reduced alcohol consumption) compared with the same treatment content delivered face-to-face in specialized addiction treatment.

The design is a two-armed randomized controlled trial, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use as well as alcohol dependence, depression, anxiety, quality of life and costs for the treatments. A minimum of 350 participants will be recruited and randomized into two groups:

Intervention group 1: All participants in this group will have access to the five-module Internet-based treatment program for harmful alcohol use and have access to a therapist with training in psychotherapy (CBT) who assists and counsels the participant throughout the program.

Intervention group 2: All participants in this group will attend five face-to-face treatment sessions in specialized addiction treatment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 303
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

• 16 points on Alcohol Use Disorders Identification Test or at least 3 criteria on the International Classification of Diseases (ICD-10) for Alcohol Dependence

• Resident in Stockholm County

Exclusion Criteria:

• Lack of understanding of the Swedish language.

• Doctor's assessment that there is a risk for severe withdrawal symptoms, risk for suicide or mental illness requiring separate care.

• Doctor's assessment that there is a need for medication for alcohol dependence.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorders
• Alcoholism

Intervention

Behavioral:
• Guide to better alcohol habits
A treatment for harmful alcohol use based on Motivational Interviewing, Cognitive Behavioral Treatment and Relapse prevention, focusing on: Motivation to change harmful alcohol use, defining a goal for the treatment, self-control strategies, risk situations, planning alternative behaviors and relapse prevention.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method		3 months post-randomization
Secondary	Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method		6 months post-randomization
Secondary	Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method		12 months post-randomization
Secondary	Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method		24 months post-randomization
Secondary	Alcohol Use Disorders Identification Test score		3 months post-randomization
Secondary	Alcohol Use Disorders Identification Test score		6 months post-randomization
Secondary	Alcohol Use Disorders Identification Test score		12 months post-randomization
Secondary	Alcohol Use Disorders Identification Test score		24 months post-randomization
Secondary	Number of criteria for alcohol dependence according to International Classification of Diseases - 10		3 months post-randomization
Secondary	Number of criteria for alcohol dependence according to International Classification of Diseases - 10		6 months post-randomization
Secondary	Number of criteria for alcohol dependence according to International Classification of Diseases - 10		12 months post-randomization
Secondary	Number of criteria for alcohol dependence according to International Classification of Diseases - 10		24 months post-randomization
Secondary	Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V		3 months post-randomization
Secondary	Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V		6 months post-randomization
Secondary	Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V		12 months post-randomization
Secondary	Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V		24 months post-randomization
Secondary	Number of days absent from work due to illness		3 months post-randomization
Secondary	Number of days absent from work due to illness		6 months post-randomization
Secondary	Number of days absent from work due to illness		12 months post-randomization
Secondary	Number of days absent from work due to illness		24 months post-randomization
Secondary	Score on Montgomery-Åsberg Depression Rating Scale		3 months post-randomization
Secondary	Score on Montgomery-Åsberg Depression Rating Scale		6 months post-randomization
Secondary	Score on Montgomery-Åsberg Depression Rating Scale		12 months post-randomization
Secondary	Score on Montgomery-Åsberg Depression Rating Scale		24 months post-randomization
Secondary	Score on Generalised Anxiety Disorder 7-item scale		3 months post-randomization
Secondary	Score on Generalised Anxiety Disorder 7-item scale		6 months post-randomization
Secondary	Score on Generalised Anxiety Disorder 7-item scale		12 months post-randomization
Secondary	Score on Generalised Anxiety Disorder 7-item scale		24 months post-randomization
Secondary	Score on EQ-5D measuring the quality of life		3 months post-randomization
Secondary	Score on EQ-5D measuring the quality of life		6 months post-randomization
Secondary	Score on EQ-5D measuring the quality of life		12 months post-randomization
Secondary	Score on EQ-5D measuring the quality of life		24 months post-randomization
Secondary	Cost for treatment		3 months post-randomization
Secondary	Cost for treatment		6 months post-randomization
Secondary	Cost for treatment		12 months post-randomization
Secondary	Cost for treatment		24 months post-randomization