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Internet Based Cognitive Behavior Treatment for Alcohol Use Disorders (ICBT-AUD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02645721
Recruitment Status : Active, not recruiting
First Posted : January 5, 2016
Last Update Posted : September 6, 2018
Sponsor:
Collaborator:
Göteborg University
Information provided by (Responsible Party):
Anne H Berman, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorders Behavioral: Extended self-help program with guidance Behavioral: Briefer Self-help program, no guidance Behavioral: WL: Extended self-help program, choice of guidance intensity Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Internet Based Cognitive Behavior Treatment for Alcohol Use Disorders - a Randomized Controlled Trial
Study Start Date : January 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: Extended self-help program with guidance
The program is a comprehensive CBT program lasting 12 weeks, with as many modules. The modules are quite extensive. A guide with basic education in psychotherapy assists and counsels participants online.
Behavioral: Extended self-help program with guidance
See arm description for Experimental
Other Name: ePlus with guidance

Active Comparator: Briefer Self-help program, no guidance
This self-help program also lasts 12 weeks but contains only 9 modules; a pause occurs during the final weeks of the program for self-testing of acquired skills. The modules are quite brief. Participants receive no guidance.
Behavioral: Briefer Self-help program, no guidance
See arm description for Active Comparator
Other Name: eChange

WL: Extended self-help program, choice of guidance intensity
Participants will be put on a waiting list. After 12 weeks on the waiting list, participants will receive access the the extended self-help program used in the experimental arm. However, participants will be offered a choice between three guidance options of varying intensity: proactive guidance, reactive guidance (only at participant request) or no guidance.
Behavioral: WL: Extended self-help program, choice of guidance intensity
See arm description for Waiting list.
Other Name: ePlus with choice of guidance intensity




Primary Outcome Measures :
  1. Time Line Follow Back [ Time Frame: Screening; Changes before treatment, Post-treatment (12 weeks); and changes after 3-, 12-, and 24-months post-treatment ]
    Number of standard drinks during preceding week (using the Time Line Follow Back)

  2. Time Line Follow Back [ Time Frame: Screening; Changes before treatment, Post-treatment (12 weeks); and changes after 3-, 12-, and 24-months post-treatment ]
    Days of heavy drinking during preceding week (using the Time Line Follow Back)


Secondary Outcome Measures :
  1. Alcohol Use Disorders Identification Test [ Time Frame: Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment ]
    assessement of alcohol use problems

  2. Alcohol Abstinence Self Efficacy Scale [ Time Frame: Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment ]
    instrument measuring self-efficacy

  3. Penn Alcohol Craving Scale [ Time Frame: Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment ]
    instrument measuring craving for alcohol

  4. Montgomery Asberg Depression Rating Scale [ Time Frame: Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment ]
    instrument measuring depression

  5. Euro-QOL 5 D [ Time Frame: Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment ]
    instrument measuring quality of life

  6. Generalized Anxiety Disorder-7 [ Time Frame: Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment ]
    instrument measuring anxiety

  7. Trimbos and iMTA questionnaire on cCosts associated with Psychiatric illness (TiC-P) [ Time Frame: Screening, 12 months, 24 months post-treatment ]
    Instrument measuring health care consumption and cost-effectiveness (Bouwmans et al., 2013

  8. Self-report questionnnaire on satisfaction with internet treatment usability features [ Time Frame: Post-treatment (12 weeks after before-treatment measure) ]
    This instrument contains 40 questions about satisfaction with various features of the internet-based treatment. Results will be analyzed on an aggregated group level. The questionnaire was constructed by the Internet psychiatry clinic in Stockholm.

  9. Adult ADHD Self Report Scale (ASRS) [ Time Frame: Screening ]
    Screening of ADHD symptoms to be used as predictor of treatment outcome

  10. Health-relevant Personality traits from a Five-factor perspective (hp5i) [ Time Frame: Screening ]
    Screening of personality traits to be used as predictor of treatment outcome

  11. Adverse Events [ Time Frame: Halfway through treatment (6 weeks after before-treatment measure) and post-treatment (12 weeks after before-treatment measure) ]
    Brief questionnaire with questions about any negative side effects of the treatment

  12. Treatment Credibility Scale [ Time Frame: 3 weeks after before-treatment measure ]
    Brief questionnaire about if the treatment this far is perceived as effective

  13. SCID- section of Alcohol Use Disorders (adjusted to DSM5) [ Time Frame: Screening interview, 12 and 24 months post-treatment ]
    Diagnostic interview via telephone, diagnostic criteria of Alcohol Use Disorders (this will be undertaken if resurces allow). This will be a masked assessment, the interviewer will not know which original group the participant was randomized to



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02645721


Locations
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Sweden
Karolinska Institutet
Stockholm, Sweden, 11364
Sponsors and Collaborators
Karolinska Institutet
Göteborg University
Investigators
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Principal Investigator: Anne H Berman, PhD Karolinska Institutet

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Responsible Party: Anne H Berman, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02645721    
Other Study ID Numbers: 2015/2014-31
First Posted: January 5, 2016    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders