NCT06774716

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 14, 2025

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

3.8 years

First QC Date

May 10, 2022

Last Update Submit

January 8, 2025

Conditions

Keywords

Problematic alcohol useWork lifeCognitive Behavior TherapyFeasibilityOutcomeEmployee assistance programInternetqualitativequantitative

Outcome Measures

Primary Outcomes (1)

  • Time Line Follow Back (TLFB)

    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 Outcomes (4)

  • Alcohol Use Disorders Identification Test (AUDIT)

    Baseline and 14 weeks, 6 months, 12 months

  • Patient Health Questionnaire (PHQ-9)

    Baseline and 14 weeks, 6 months, 12 months

  • Generalized Anxiety Disorder-7 (GAD-7)

    Baseline and 14 weeks, 6 months, 12 months

  • The WHO-5 well-being-index

    Baseline and 14 weeks, 6 months, 12 months

Study Arms (2)

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

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

Interventions

A self help program consisting of 12 modules and access to therapist guidance through messages. Including three video session.

ICBT

Face-to-face therapy with a licenced psychologist or licenced psychotherapist, including 10-15 sessions.

Face-to-face treatment as ususal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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;

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stockholm University

Stockholm, Sweden, 18234, Sweden

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Secondary Prevention

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TherapeuticsPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPublic Health PracticePublic HealthEnvironment and Public Health

Study Officials

  • Kristina Sundqvist, PhD

    Stockholm University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 10, 2022

First Posted

January 14, 2025

Study Start

March 15, 2020

Primary Completion

December 31, 2023

Study Completion

January 1, 2025

Last Updated

January 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations