Clinical trial NCT02645721: Internet Based Cognitive Behavior Treatment for Alcohol Use Disorders
Official title: Internet Based Cognitive Behavior Treatment for Alcohol Use Disorders - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorders
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Göteborg University
First posted: 2016-01-05
Enrollment: 166
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 study is to determine whether extensive internet based cognitive behavior treatment program with guidance is a more effective method to treat individuals with alcohol use disorders than a briefer cognitive behavior treatment program without guidance.

Detailed description: Two Internet based programs based on cognitive behavioral therapy and relapse prevention are evaluated among Internet help seekers, and compared to a waiting list. The design is a three armed randomized controlled trial, and outcomes are measured in terms of changes in alcohol consumption (mean consumption/week, number of heavy drinking days/week), problematic alcohol use, self efficacy, craving, as well as depression, anxiety and quality of life. In addition to this, the following instruments will be used as predictors: ASRS (ADHD), Hp5i (personality assessment). TIC-P, an instrument measuring cost effectiveness will also be used. Treatment Credibility and Adverse Events will also be assessed, the former once during the third week of treatment, and the latter once half way through treatment and once after treatment.

Primary hypothesis is that the more extended program with guidance (group 1) is more effective in reducing mean alcohol consumption and number of heavy drinking days compared to the briefer program with no guidance (group 2), as well as compared to a waiting list (group 3). A responder to treatment is defined as a participant drinking less than 9 (women)/ 14(men) glasses per week and no more than 3 (women)/4 (men) glasses per drinking day during that week.

A minimum of 169 participants will be recruited in two phases: first through an online screening and then through a diagnostic telephone assessment, where SCID will be used to diagnose Alcohol Use Disorders and MINI will be used to diagnose other psychiatric diagnoses. The telephone assessment and all guidance will be conducted by licensed psychologists or master students in psychology under supervision by licensed psychologists.

Included participants will be randomized into three groups:

Group 1: All participants in this group will have access to an extended cognitive behavioral treatment program and have access to a guide with basic training in psychotherapy (CBT) who assists and counsels the participant throughout the program.

Group 2: Participants in this group will have access to a briefer cognitive behavior treatment program with no access to a guide.

Group 3: Participants in this group will be placed on a waiting list for 12 weeks. Thereafter, they will be given access to the same extended cognitive behavior treatment program as Group 1; they will also be offered a possibility to choose between three guidance options: Choice 1: guide with intensive support, Choice 2: guide with support only at request, Choice 3: no guide.

Interim analyses will be undertaken in May 2016 by graduate students in Clinical psychology writing their MSc theses.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years
* access to the internet
* consumption of at least 9 (females)/14 (males) glasses of alcohol during the preceding week
* AUDIT ≥ 14 for females, ≥ 16 for men
* have an Alcohol Use Disorder according to the DSM-5 (i.e., at least 2 out of 11 criteria)

Exclusion Criteria:

* insufficient Swedish skills
* reading or writing difficulties, if it is to a degree that it will hamper the treatment
* concurrent other psychological treatment with a content resembling treatments in this study
* severe depression defined as a score of more than 30 on the MADRS-S
* suicide-risk defined as more than 4 points on the MADRS-S question 9, or based on the structured interview
* Drug use problems defined as ≥ 8 p on the DUDIT
* somatic or psychiatric disorders that are contraindicated for the treatment or impairs the ability to receive it (for example schizophrenia, bipolar disease, PTSD)
* has during the last 3 weeks begun medication for alcohol problems or other psychiatric disorder

Primary outcomes:
measure: Time Line Follow Back
timeFrame: Screening; Changes before treatment, Post-treatment (12 weeks); and changes after 3-, 12-, and 24-months post-treatment
measure: Time Line Follow Back
timeFrame: Screening; Changes before treatment, Post-treatment (12 weeks); and changes after 3-, 12-, and 24-months post-treatment
Secondary outcomes:
measure: Alcohol Use Disorders Identification Test
timeFrame: Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
measure: Alcohol Abstinence Self Efficacy Scale
timeFrame: Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
measure: Penn Alcohol Craving Scale
timeFrame: Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
measure: Montgomery Asberg Depression Rating Scale
timeFrame: Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
measure: Euro-QOL 5 D
timeFrame: Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
measure: Generalized Anxiety Disorder-7
timeFrame: Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
measure: Trimbos and iMTA questionnaire on cCosts associated with Psychiatric illness (TiC-P)
timeFrame: Screening, 12 months, 24 months post-treatment
measure: Self-report questionnnaire on satisfaction with internet treatment usability features
timeFrame: Post-treatment (12 weeks after before-treatment measure)
measure: Adult ADHD Self Report Scale (ASRS)
timeFrame: Screening
measure: Health-relevant Personality traits from a Five-factor perspective (hp5i)
timeFrame: Screening
measure: Adverse Events
timeFrame: Halfway through treatment (6 weeks after before-treatment measure) and post-treatment (12 weeks after before-treatment measure)
measure: Treatment Credibility Scale
timeFrame: 3 weeks after before-treatment measure
measure: SCID- section of Alcohol Use Disorders (adjusted to DSM5)
timeFrame: Screening interview, 12 and 24 months post-treatment
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Anne H Berman, PhD
role: PRINCIPAL_INVESTIGATOR
References: