Clinical trial NCT02671019: Effectiveness and Costs of Internet-based Treatment for Harmful Alcohol Use and Face-to-face Treatment in Addiction Care
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Use Disorders
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2016-02-02
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
timeFrame: 3 months post-randomization
Secondary outcomes:
measure: Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
timeFrame: 6 months post-randomization
measure: Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
timeFrame: 12 months post-randomization
measure: Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
timeFrame: 24 months post-randomization
measure: Alcohol Use Disorders Identification Test score
timeFrame: 3 months post-randomization
measure: Alcohol Use Disorders Identification Test score
timeFrame: 6 months post-randomization
measure: Alcohol Use Disorders Identification Test score
timeFrame: 12 months post-randomization
measure: Alcohol Use Disorders Identification Test score
timeFrame: 24 months post-randomization
measure: Number of criteria for alcohol dependence according to International Classification of Diseases - 10
timeFrame: 3 months post-randomization
measure: Number of criteria for alcohol dependence according to International Classification of Diseases - 10
timeFrame: 6 months post-randomization
measure: Number of criteria for alcohol dependence according to International Classification of Diseases - 10
timeFrame: 12 months post-randomization
measure: Number of criteria for alcohol dependence according to International Classification of Diseases - 10
timeFrame: 24 months post-randomization
measure: Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
timeFrame: 3 months post-randomization
measure: Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
timeFrame: 6 months post-randomization
measure: Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
timeFrame: 12 months post-randomization
measure: Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
timeFrame: 24 months post-randomization
measure: Number of days absent from work due to illness
timeFrame: 3 months post-randomization
measure: Number of days absent from work due to illness
timeFrame: 6 months post-randomization
measure: Number of days absent from work due to illness
timeFrame: 12 months post-randomization
measure: Number of days absent from work due to illness
timeFrame: 24 months post-randomization
measure: Score on Montgomery-Åsberg Depression Rating Scale
timeFrame: 3 months post-randomization
measure: Score on Montgomery-Åsberg Depression Rating Scale
timeFrame: 6 months post-randomization
measure: Score on Montgomery-Åsberg Depression Rating Scale
timeFrame: 12 months post-randomization
measure: Score on Montgomery-Åsberg Depression Rating Scale
timeFrame: 24 months post-randomization
measure: Score on Generalised Anxiety Disorder 7-item scale
timeFrame: 3 months post-randomization
measure: Score on Generalised Anxiety Disorder 7-item scale
timeFrame: 6 months post-randomization
measure: Score on Generalised Anxiety Disorder 7-item scale
timeFrame: 12 months post-randomization
measure: Score on Generalised Anxiety Disorder 7-item scale
timeFrame: 24 months post-randomization
measure: Score on EQ-5D measuring the quality of life
timeFrame: 3 months post-randomization
measure: Score on EQ-5D measuring the quality of life
timeFrame: 6 months post-randomization
measure: Score on EQ-5D measuring the quality of life
timeFrame: 12 months post-randomization
measure: Score on EQ-5D measuring the quality of life
timeFrame: 24 months post-randomization
measure: Cost for treatment
timeFrame: 3 months post-randomization
measure: Cost for treatment
timeFrame: 6 months post-randomization
measure: Cost for treatment
timeFrame: 12 months post-randomization
measure: Cost for treatment
timeFrame: 24 months post-randomization
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
References: