- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02671019
Effectiveness and Costs of Internet-based Treatment for Harmful Alcohol Use and Face-to-face Treatment in Addiction Care
Comparing Effectiveness and Costs of Internet-based Treatment for Problematic Alcohol Use and Face-to-face Treatment in Addiction Care: A Randomized Controlled Trial
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:
- 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.
- 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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Stockholm, Sverige, 171 77
- Karolinska Institutet
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Internet-based treatment
A five-module Internet-based treatment program for harmful alcohol use (including therapist support) 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.
|
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.
|
|
Aktiv komparator: Face-to-face treatment
Same treatment content as in the Internet-based treatment delivered via face-to-face treatment sessions in specialized addiction treatment.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Tidsram: 3 months post-randomization
|
3 months post-randomization
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Tidsram: 6 months post-randomization
|
6 months post-randomization
|
|
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Tidsram: 12 months post-randomization
|
12 months post-randomization
|
|
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Tidsram: 24 months post-randomization
|
24 months post-randomization
|
|
Alcohol Use Disorders Identification Test score
Tidsram: 3 months post-randomization
|
3 months post-randomization
|
|
Alcohol Use Disorders Identification Test score
Tidsram: 6 months post-randomization
|
6 months post-randomization
|
|
Alcohol Use Disorders Identification Test score
Tidsram: 12 months post-randomization
|
12 months post-randomization
|
|
Alcohol Use Disorders Identification Test score
Tidsram: 24 months post-randomization
|
24 months post-randomization
|
|
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Tidsram: 3 months post-randomization
|
3 months post-randomization
|
|
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Tidsram: 6 months post-randomization
|
6 months post-randomization
|
|
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Tidsram: 12 months post-randomization
|
12 months post-randomization
|
|
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Tidsram: 24 months post-randomization
|
24 months post-randomization
|
|
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Tidsram: 3 months post-randomization
|
3 months post-randomization
|
|
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Tidsram: 6 months post-randomization
|
6 months post-randomization
|
|
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Tidsram: 12 months post-randomization
|
12 months post-randomization
|
|
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Tidsram: 24 months post-randomization
|
24 months post-randomization
|
|
Number of days absent from work due to illness
Tidsram: 3 months post-randomization
|
3 months post-randomization
|
|
Number of days absent from work due to illness
Tidsram: 6 months post-randomization
|
6 months post-randomization
|
|
Number of days absent from work due to illness
Tidsram: 12 months post-randomization
|
12 months post-randomization
|
|
Number of days absent from work due to illness
Tidsram: 24 months post-randomization
|
24 months post-randomization
|
|
Score on Montgomery-Åsberg Depression Rating Scale
Tidsram: 3 months post-randomization
|
3 months post-randomization
|
|
Score on Montgomery-Åsberg Depression Rating Scale
Tidsram: 6 months post-randomization
|
6 months post-randomization
|
|
Score on Montgomery-Åsberg Depression Rating Scale
Tidsram: 12 months post-randomization
|
12 months post-randomization
|
|
Score on Montgomery-Åsberg Depression Rating Scale
Tidsram: 24 months post-randomization
|
24 months post-randomization
|
|
Score on Generalised Anxiety Disorder 7-item scale
Tidsram: 3 months post-randomization
|
3 months post-randomization
|
|
Score on Generalised Anxiety Disorder 7-item scale
Tidsram: 6 months post-randomization
|
6 months post-randomization
|
|
Score on Generalised Anxiety Disorder 7-item scale
Tidsram: 12 months post-randomization
|
12 months post-randomization
|
|
Score on Generalised Anxiety Disorder 7-item scale
Tidsram: 24 months post-randomization
|
24 months post-randomization
|
|
Score on EQ-5D measuring the quality of life
Tidsram: 3 months post-randomization
|
3 months post-randomization
|
|
Score on EQ-5D measuring the quality of life
Tidsram: 6 months post-randomization
|
6 months post-randomization
|
|
Score on EQ-5D measuring the quality of life
Tidsram: 12 months post-randomization
|
12 months post-randomization
|
|
Score on EQ-5D measuring the quality of life
Tidsram: 24 months post-randomization
|
24 months post-randomization
|
|
Cost for treatment
Tidsram: 3 months post-randomization
|
3 months post-randomization
|
|
Cost for treatment
Tidsram: 6 months post-randomization
|
6 months post-randomization
|
|
Cost for treatment
Tidsram: 12 months post-randomization
|
12 months post-randomization
|
|
Cost for treatment
Tidsram: 24 months post-randomization
|
24 months post-randomization
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Beräknad)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2014/1758-31/2
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