Internet Based Cognitive Behavior Treatment for Alcohol Use Disorders

Alcohol Use Disorders Clinical Trial

— ICBT-AUD  

Official title:

Internet Based Cognitive Behavior Treatment for Alcohol Use Disorders - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02645721
• Other study ID #: 2015/2014-31
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: June 2019

Study information

• Verified date: June 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorders
• Alcoholism

Intervention

Behavioral:
• Extended self-help program with guidance
See arm description for Experimental
• Briefer Self-help program, no guidance
See arm description for Active Comparator
• WL: Extended self-help program, choice of guidance intensity
See arm description for Waiting list.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time Line Follow Back	Number of standard drinks during preceding week (using the Time Line Follow Back)	Screening; Changes before treatment, Post-treatment (12 weeks); and changes after 3-, 12-, and 24-months post-treatment
Primary	Time Line Follow Back	Days of heavy drinking during preceding week (using the Time Line Follow Back)	Screening; Changes before treatment, Post-treatment (12 weeks); and changes after 3-, 12-, and 24-months post-treatment
Secondary	Alcohol Use Disorders Identification Test	assessement of alcohol use problems	Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Secondary	Alcohol Abstinence Self Efficacy Scale	instrument measuring self-efficacy	Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Secondary	Penn Alcohol Craving Scale	instrument measuring craving for alcohol	Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Secondary	Montgomery Asberg Depression Rating Scale	instrument measuring depression	Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Secondary	Euro-QOL 5 D	instrument measuring quality of life	Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Secondary	Generalized Anxiety Disorder-7	instrument measuring anxiety	Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Secondary	Trimbos and iMTA questionnaire on cCosts associated with Psychiatric illness (TiC-P)	Instrument measuring health care consumption and cost-effectiveness (Bouwmans et al., 2013	Screening, 12 months, 24 months post-treatment
Secondary	Self-report questionnnaire on satisfaction with internet treatment usability features	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.	Post-treatment (12 weeks after before-treatment measure)
Secondary	Adult ADHD Self Report Scale (ASRS)	Screening of ADHD symptoms to be used as predictor of treatment outcome	Screening
Secondary	Health-relevant Personality traits from a Five-factor perspective (hp5i)	Screening of personality traits to be used as predictor of treatment outcome	Screening
Secondary	Adverse Events	Brief questionnaire with questions about any negative side effects of the treatment	Halfway through treatment (6 weeks after before-treatment measure) and post-treatment (12 weeks after before-treatment measure)
Secondary	Treatment Credibility Scale	Brief questionnaire about if the treatment this far is perceived as effective	3 weeks after before-treatment measure
Secondary	SCID- section of Alcohol Use Disorders (adjusted to DSM5)	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	Screening interview, 12 and 24 months post-treatment