Internet-delivered Cognitive Behavior Therapy for Problematic Alcohol Use in a Working Life Setting (Simba)

January 8, 2025 updated by: Kristina Sundqvist, Stockholm University

Internet-delivered Cognitive Behavior Therapy for Problematic Alcohol Use in a Working Life Setting: a Research Protocol for Qualitative and Quantitative Evaluation of Feasibility and Outcomes

Internet-based cognitive behavioral treatment (ICBT) for mental health issues has been successfully implemented in routine health care and research indicates that ICBT can also be applied to decrease problematic alcohol use in healthcare as well as working life settings. However, qualitative studies investigating the feasibility of implementing ICBT in a working life context have been lacking. The current study will investigate the feasibility of delivering ICBT for problematic alcohol use within an employee assistance program (EAP), and will compare outcomes for ICBT with face-to-face treatment in a naturalistic quantitative study. Recruitment to the study follows employer contact with the EAP regarding an employee's presumed problematic alcohol consumption, leading to a five-session in-person psychological assessment. All assessed employees recommended ICBT or face-to-face treatment will be offered participation in the study. In addition to quantitative evaluation, interviews will be conducted with employees and their employer representatives following ICBT to elucidate both stakeholders' experience and perception of ICBT in the work life context. Thematic analysis and grounded theory will be used to analyze the interview material. Outcome comparisons between ICBT and face-to-face treatment will be assessed quantitatively using a Reliable Change Index and analysis of variance or other relevant statistical analyses such as multilevel modeling.

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.

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.
Observational

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.
38

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

  • Sweden
      • Stockholm, Sweden, 18234
        • Stockholm University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Employees that have undergone an assessment as a rehabilitation intervention initiated by the employer. Participants included have a problematic alcohol use, and are referred to treatment where the employer covers the cost of treatment.

Description

Inclusion Criteria:

18 years; access to the Internet; problematic alcohol use assessed by a licenced psychologist; referred to treatment within a rehabilitation intervention initiated by the work-place; Work-place covers treatment costs;

Exclusion Criteria:

not adequately fluent in Swedish; drug use; suicidality; indications of excessive use of the internet and computer gaming and/or gambling;

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
ICBT
Internet-based cognitive behaviour treatment, based on relapse prevention, delivered in a work-life setting.
Behavioral: Internet-based cognitive behavioural treatment and relapse prevention
A self help program consisting of 12 modules and access to therapist guidance through messages. Including three video session.
Face-to-face treatment as ususal
Face-to-face treatment as usual, based on relapse prevention, delivered in a work-life setting.
Behavioral: Face-to-face cognitive behavioural treatment or short-term psycodynamic therapy with relapse prevention
Face-to-face therapy with a licenced psychologist or licenced psychotherapist, including 10-15 sessions.

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
Time Line Follow Back (TLFB)
Time Frame: Baseline and 14 weeks, 6 months, 12 months and
Change in total TLFB score (consumption during preceding week), as a summarized measure of alcohol consumption
Baseline and 14 weeks, 6 months, 12 months and

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
Alcohol Use Disorders Identification Test (AUDIT)
Time Frame: Baseline and 14 weeks, 6 months, 12 months
Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems)
Baseline and 14 weeks, 6 months, 12 months
Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline and 14 weeks, 6 months, 12 months
Change in total PHQ-9 score, as a summarized measure of depression
Baseline and 14 weeks, 6 months, 12 months
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: Baseline and 14 weeks, 6 months, 12 months
Change in total GAD-7 score, as a summarized measure of anxiety
Baseline and 14 weeks, 6 months, 12 months
The WHO-5 well-being-index
Time Frame: Baseline and 14 weeks, 6 months, 12 months
Change in total WHO-5 score, as a summarized measure of general well-being
Baseline and 14 weeks, 6 months, 12 months

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.
Stockholm University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Karolinska Institutet
Uppsala University
AFA Insurance
Systembolagets alkoholforskningsråd
Alna Sverige AB

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.
  • Principal Investigator: Kristina Sundqvist, PhD, Stockholm University

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.
March 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.
December 31, 2023

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.
January 1, 2025

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).
May 10, 2022

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.
January 8, 2025

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.
March 25, 2025

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 25, 2025

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.
January 8, 2025

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.
January 1, 2025

More Information

Terms related to this study

Keywords

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.
  • 1800008

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

product manufactured in and exported from the U.S.

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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