Back to results

Internet Based Cognitive Behavior Treatment for Alcohol Problems (ICBT-AP)

Primary Purpose

Alcohol Use Disorders

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Internet-based CBT for alcohol problems

About this trial

This is an interventional treatment trial for Alcohol Use Disorders focused on measuring alcohol use disorder, internet, cognitive behavior therapy, relapse prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

≥ 18 years
access to the Internet
problematic alcohol use defined as ≥ 16 p or more for men and ≥ 14 p or more for women in the Alcohol Use Identification Scale

Exclusion Criteria:

not adequately fluent in Swedish
reading or writing impairment if this is so severe as to affect treatment
ongoing psychological treatment with content similar to the treatment being studied
suicide risk defined as ≥ 4 p på MADRS-S Q 9 or through a telephone interview with clinician
severe depression defined as MADRS-S ≥ 30 p
somatic or psychiatric conditions that are contraindicated for the treatment such as psychosis, bipolar disorder (depressive or manic phase), severe post traumatic stress disorder.
has during the last 3 weeks begun using medication for alcohol problems or other psychiatric disorder

Sites / Locations

Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Internet-based CBT for alcohol problems

Arm Description

A 12-week internet-based cognitive behavior treatment (CBT) and relapse prevention program. The subjects will have access to a psychologist guiding them through the program.

Outcomes

Primary Outcome Measures

Time Line Follow Back (TLFB)

Change in total TLFB score (consumption during preceding week), as a summarized

Secondary Outcome Measures

Alcohol Use Disorders Identification Test (AUDIT)

Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems)

Drug Use Identification Test (DUDIT)

Change in total DUDIT score, as a summarized measure of drug use (including drug consumption and drug-related problems)

Montgomery Asberg Depression Rating Scale - self report (MADRS-S)

Change in total MADRS-S score, as a summarized measure of depression

World Health Organization Quality of Life Scale (WHOQOL-BREF)

Change in total WHOQOL-BREF score, as a summarized measure of quality of life

Alcohol Abstinence Self Efficacy Scale (AASES)

Change in total AASES score, as a summarized measure of self efficacy

Penn Alcohol Craving Scale (PACS)

Readiness to Change Questionnaire (RTCQ)

Score in RTCQ as a summarized measure of motivation used as predictor for other outcomes

Full Information

NCT ID

NCT02384278

First Posted

February 26, 2015

Last Updated

August 12, 2019

Sponsor

Karolinska Institutet

Collaborators

Göteborg University

1. Study Identification

Unique Protocol Identification Number

NCT02384278

Brief Title

Internet Based Cognitive Behavior Treatment for Alcohol Problems

Acronym

ICBT-AP

Official Title

Internet Based Cognitive Behavior Treatment for Alcohol Problems: A Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

March 2015 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

Collaborators

Göteborg University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine whether internet based cognitive behavior therapy might be effective in the treatment of alcohol problems.

Detailed Description

A 12 week Internet based self help program based on cognitive behavioral therapy and relapse prevention is tested among Internet help seekers as well as among patients seeking help in addiction care.The design is a one armed pilot study, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use, self efficacy, craving, as well as depression and quality of life. 20 participants are recruited entirely online from an open access website and 20 participants are recruited through information given to them at an addiction clinic. All participants have access to the same self help program and have access to a licensed psychologist who guides the person all the way through the program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Use Disorders

Keywords

alcohol use disorder, internet, cognitive behavior therapy, relapse prevention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Internet-based CBT for alcohol problems

Arm Type

Experimental

Arm Description

A 12-week internet-based cognitive behavior treatment (CBT) and relapse prevention program. The subjects will have access to a psychologist guiding them through the program.

Intervention Type

Behavioral

Intervention Name(s)

Internet-based CBT for alcohol problems

Intervention Description

A 12-week internet-based program based on cognitive behavior treatment (CBT) and relapse prevention

Primary Outcome Measure Information:

Title

Time Line Follow Back (TLFB)

Description

Change in total TLFB score (consumption during preceding week), as a summarized

Time Frame

Baseline, 14 and 26 weeks

Secondary Outcome Measure Information:

Title

Alcohol Use Disorders Identification Test (AUDIT)

Description

Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems)

Time Frame

Baseline, 14 and 26 weeks

Title

Drug Use Identification Test (DUDIT)

Description

Change in total DUDIT score, as a summarized measure of drug use (including drug consumption and drug-related problems)

Time Frame

Baseline, 14 and 26 weeks

Title

Montgomery Asberg Depression Rating Scale - self report (MADRS-S)

Description

Change in total MADRS-S score, as a summarized measure of depression

Time Frame

Baseline, 14 and 26 weeks

Title

World Health Organization Quality of Life Scale (WHOQOL-BREF)

Description

Change in total WHOQOL-BREF score, as a summarized measure of quality of life

Time Frame

Baseline, 14 and 26 weeks

Title

Alcohol Abstinence Self Efficacy Scale (AASES)

Description

Change in total AASES score, as a summarized measure of self efficacy

Time Frame

Baseline, 14 and 26 weeks

Title

Penn Alcohol Craving Scale (PACS)

Time Frame

Baseline, 14 and 26 weeks

Title

Readiness to Change Questionnaire (RTCQ)

Description

Score in RTCQ as a summarized measure of motivation used as predictor for other outcomes

Time Frame

Baseline, 14 and 26 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ≥ 18 years access to the Internet problematic alcohol use defined as ≥ 16 p or more for men and ≥ 14 p or more for women in the Alcohol Use Identification Scale Exclusion Criteria: not adequately fluent in Swedish reading or writing impairment if this is so severe as to affect treatment ongoing psychological treatment with content similar to the treatment being studied suicide risk defined as ≥ 4 p på MADRS-S Q 9 or through a telephone interview with clinician severe depression defined as MADRS-S ≥ 30 p somatic or psychiatric conditions that are contraindicated for the treatment such as psychosis, bipolar disorder (depressive or manic phase), severe post traumatic stress disorder. has during the last 3 weeks begun using medication for alcohol problems or other psychiatric disorder

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne H Berman, PhD

Organizational Affiliation

Karolinska Institutet

Official's Role

Principal Investigator

Facility Information:

Facility Name

Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research

City

Stockholm

ZIP/Postal Code

11364

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The dataset, unidentified, with background characteristics and outcomes is available as below.

IPD Sharing Time Frame

Since January 31, 2017

IPD Sharing Access Criteria

Availability of data and materials The data set supporting the results of this article is available in the Open ICPSR repository with the following identifying information: Berman, A. H. (2017-01-31). High-intensity therapist-guided internet-based cognitive behavior therapy for alcohol use disorders - a pilot study. [Data set]. Ann Arbor, MI: Inter-university Consortium of Political and Social Research [distributor]. http://doi.org/10.3886/E100415V1.

IPD Sharing URL

http://doi.org/10.3886/E100415V1

Citations:

PubMed Identifier

28549424

Citation

Sundstrom C, Kraepelien M, Eek N, Fahlke C, Kaldo V, Berman AH. High-intensity therapist-guided internet-based cognitive behavior therapy for alcohol use disorder: a pilot study. BMC Psychiatry. 2017 May 26;17(1):197. doi: 10.1186/s12888-017-1355-6.

Results Reference

derived

Links:

URL

https://staff.ki.se/people/anberm

Description

Anne H Berman's research group profile

Learn more about this trial

Internet Based Cognitive Behavior Treatment for Alcohol Problems

We'll reach out to this number within 24 hrs