Therapist-guided Internet Treatment for Hazardous and Harmful Alcohol Use. A Feasibility Study

NCT04544930 | Completed

• 1 other identifier: 31352
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the present study is to test the feasibility of therapist-guided Internet treatment for hazardous (risky) and harmful alcohol use among adults 18 years and older. The hypothesis is that the intervention is feasible and that it can help people change risky drinking habits at an early stage before developing into problems that are more serious.The therapist-guided Internet treatment addresses the person's need for confidentiality and contributes to reducing the stigma associated with visiting a substance abuse clinic.

Conditions

Alcohol Abuse; Internet-Based Intervention

Outcome Measures

Primary Outcomes (2)

• The Alcohol Use Disorders Identification Test (AUDIT)

  AUDIT is a screening instrument consisting of 10 questions designed to identify hazardous (risky) and harmful use of alcohol in adults. Based on the 10 questions, a score is calculated indicating whether the person is at risk for developing more serious alcohol problems. A cut-off score of \> 6 points indicates risky use in women, and a cut-off score of \> 8 points indicates risky use in men.

  AUDIT will measure whether there is a change in alcohol intake during the treatment period (8-12 weeks) and at follow-up (6 months after the end of treatment).

• The Timeline Followback (TLFB) for alcohol

  TLFB for alcohol is an assessment tool that includes estimates of daily alcohol intake over a specific period, e.g. within seven days. TLFB provides information on various dimensions of the person's drinking habits, such as the number of drinking days and the maximum amount of alcohol consumed.

  TLFB will calculate the intake of alcohol units (AE) and change in the seven-day period from the first assessment to the 6 months follow-up.

Secondary Outcomes (5)

• The Drug-Taking Confidence Questionnaire (DTCQ).

  DTCQ will measure changes during the treatment course of 8-12 weeks, and at 6 months follow-up.

• Symptom Checklist -10 (SCL-10)

  SCL-10 will measure changes in psychological distress during the treatment course of 8-12 weeks, and at 6 months follow-up.

• Patient Health Questionnaire, PHQ-9

  Patient Health Questionnaire (PHQ-9) will measure changes in symptoms of depression during the treatment course of 8-12 weeks, and at 6 months follow-up.

• General Anxiety Disorder (GAD-7).

  GAD-7 will measure changes in symptoms of anxiety during the treatment course of 8-12 weeks, and at 6 months follow-up.

• EuroQol five-dimensional (EQ-5D) descriptive system (EQ-5D-5L)

  EQ-5D-5L will measure changes in health-related quality of life during the treatment course of 8-12 weeks, and at 6 months follow-up.

Other Outcomes (1)

• Qualitative interviews

  Qualitative interviews will be conducted at the end of treatment, immediately after 8-12 weeks completed treatment

Study Arms (1)

therapist-guided

EXPERIMENTAL

Therapist-guided Internet treatment based on cognitive behavior therapy (ICBT).

Behavioral: therapist-guided

Interventions

therapist-guided BEHAVIORAL

Therapist-guided Internet treatment comprises eight text modules on the Internet that include psychoeducation, tasks and exercises. Key elements are setting goals for treatment, identifying and challenging negative automatic thoughts through a number of exercises and behavioral experiments, as well as making a plan for relapse prevention. Therapist guidance is secondary to the self-help modules, and the therapist provides feedback to the patient online in the secured program once a week

therapist-guided

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• access to the Internet
• interested in receiving Internet treatment for changing drinking habits
• a score of 6 or higher for women and 8 or higher for men on the Alcohol Use Disorder Identification Test (AUDIT)

You may not qualify if:

• diagnosed alcohol dependence or addiction to other drugs and already in treatment
• serious reading and/or writing difficulties
• cognitive impairment/dementia
• severe mental disorder or in need of other treatment

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (2)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Vestfold Hospital

Tønsberg, 3103, Norway

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Else Marie Løberg, PhD

  Haukeland University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: September 10, 2020
• Study Start: September 15, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)