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Completed

NCT Number: NCT06774716

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stockholm University

Stockholm, Sweden, 18234

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Internet-based cognitive behavioural treatment and relapse prevention

Behavioral

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

Face-to-face cognitive behavioural treatment or short-term psycodynamic therapy with relapse prevention

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Stockholm University

Other

Collaborators

  • AFA Insurance
  • Alna Sverige AB
  • Karolinska Institutet
  • Systembolagets alkoholforskningsråd
  • Uppsala University

Registry information

Official study title

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

Acronym: Simba

Important dates

Study start
2020
Primary completion
2023
Study completion
2025
First posted
Jan 14, 2025
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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