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

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: Completed
• Conditions: Alcohol Use Disorder; Alcohol Abuse
• Intervention / Treatment: Behavioral: Internet-based cognitive behavioural treatment and relapse prevention; Behavioral: Face-to-face cognitive behavioural treatment or short-term psycodynamic therapy with relapse prevention

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 18234
    • Stockholm University

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline and 14 weeks, 6 months, 12 months
Patient Health Questionnaire (PHQ-9)	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)	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	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

• Sponsor: Stockholm University
• Collaborators: Karolinska Institutet; Uppsala University; AFA Insurance; Systembolagets alkoholforskningsråd; Alna Sverige AB
• Investigators: Principal Investigator: Kristina Sundqvist, PhD, Stockholm University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2020
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Feasibility; Outcome; Internet; Cognitive Behavior Therapy; quantitative; qualitative; Problematic alcohol use; Work life; Employee assistance program
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Alcoholism; Alcohol Drinking
• Other Study ID 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