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

March 18, 2022 updated by: Haukeland University Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background:

A significant proportion of people with substance abuse do not seek help for their problems and therefore do not receive the necessary help at an early stage. An important reason for this is the stigma associated with substance abuse. Therapist-guided Internet treatment has been developed and tested in recent years as an approach that increases access to effective treatment for a variety of mental and substance-related problems and disorders. Internet-based interventions increase the patient's choice of type of treatment and give the patient an experience of having control over their own behavior change. Moreover, such treatment is independent of where you live, and you do not need to attend a clinic. In addition, by offering therapist-guided Internet treatment, therapists can treat far more patients compared to regular face-to-face treatment. In this way, the health services, which are already under severe pressure due to many new and competing tasks, are relieved.

Research questions:

  1. Is therapist-guided Internet treatment for hazardous and harmful alcohol use feasible for self-referred persons?
  2. What factors contribute/do not contribute to the feasibility of treatment?
  3. Can the intervention help people change risky drinking habits before it develops into problems that are more serious?
  4. How do participants experience the intervention?

Methods:

Participants:

A total of 30 participants will be recruited through announcements in social media, newspapers and through GP's and other health care services. Participants will be recruited from the catchment area of Haukeland University Hospital, Western Norway, and Vestfold Hospital, Eastern Norway.

Design:

The study will be conducted as an open, 6-months follow-up study, to assess whether the design is suitable for a randomized controlled trial in the next round. Both quantitative and qualitative methods will be used to investigate the feasibility of the treatment program.

Data collection:

Assessments will be carried out at start of treatment (T1), through the treatment course (T2) and at the end of treatment (T3) and at follow-up (T4). Qualitative interviews will be conducted at the end of treatment.

Intervention:

The treatment program is developed at Vestfold Hospital, Norway. It is based on Internet- based cognitive behavior therapy (ICBT). The treatment program consists of eight text-based self-help modules on the Internet that participants can access via secure login using Bank identification (ID) (security level 4). The self-help modules include psychoeducation, tasks and exercises. The therapist guidance is secondary to the self-help modules. The therapist provides feedback to the patient online in the secured program once a week.

Statistics:

Sample size:

Since this is a feasibility study primarily intended to test the feasibility of therapist-guided Internet treatment for hazardous and harmful alcohol use, the sample will be limited to 30 participants. Therefore, power analysis is not performed.

Statistical methods:

Both statistical and interpretative methods will be used. Descriptive statistics (percentages, means, standard deviations), as well as statistical and clinical change. Qualitative in-depth interviews will be analyzed using thematic content analysis.

Plan for activities and dissemination:

Scheduled start of data collection is September 2020. The data collection will continue until the summer of 2021. The follow-up period will be completed by the end of 2021.

The results of the feasibility study will be published in peer-reviewed journals. Furthermore, the results will be disseminated to the public through media (including social media), and as information aimed at both health and social care professionals, patient groups and user forums.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5021
        • Haukeland University Hospital
      • Tønsberg, Norway, 3103
        • Vestfold Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: therapist-guided
Therapist-guided Internet treatment based on cognitive behavior therapy (ICBT).
Behavioral: therapist-guided
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Alcohol Use Disorders Identification Test (AUDIT)
Time Frame: 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).
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
Time Frame: 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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Drug-Taking Confidence Questionnaire (DTCQ).
Time Frame: DTCQ will measure changes during the treatment course of 8-12 weeks, and at 6 months follow-up.
DTCQ measures the person's confidence in his or her abilities to cope in situations that are high-risk for substance use. The tool yields information about client strengths and needs in the area of relapse potential in 50 different risk situations.
DTCQ will measure changes during the treatment course of 8-12 weeks, and at 6 months follow-up.
Symptom Checklist -10 (SCL-10)
Time Frame: SCL-10 will measure changes in psychological distress during the treatment course of 8-12 weeks, and at 6 months follow-up.
SCL-10 is a self-report questionnaire for identifying symptoms of psychological distress over the past seven days. SCL-10 contains 10 statements.
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
Time Frame: 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.
Patient Health Questionnaire (PHQ-9) consists of nine items and measures key symptoms of depression.
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).
Time Frame: GAD-7 will measure changes in symptoms of anxiety during the treatment course of 8-12 weeks, and at 6 months follow-up.
GAD-7 is a screening instrument that consists of seven items and measures key symptoms of anxiety.
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)
Time Frame: 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.
EQ-5D-5L measures health-related quality of life in five areas; mobility, personal care, activities of daily living, pain/discomfort and anxiety / depression
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 Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Qualitative interviews
Time Frame: Qualitative interviews will be conducted at the end of treatment, immediately after 8-12 weeks completed treatment
Qualitative interviews will investigate participants' expectations and experience of the intervention, focusing on both the technical solutions related to the intervention and the importance of therapist support.
Qualitative interviews will be conducted at the end of treatment, immediately after 8-12 weeks completed treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Haukeland University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Else Marie Løberg, PhD, Haukeland University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 31352

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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