Alcohol Use DisorderSimbaNCT06774716
Internet-delivered Cognitive Behavior Therapy for Problematic Alcohol Use in a Working Life Setting
An observational study of Alcohol Use Disorder and Alcohol Abuse, run by Stockholm University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Alcohol Abuse
- What is being tested?
- Internet-based cognitive behavioural treatment and relapse prevention and Face-to-face cognitive behavioural treatment or short-term psycodynamic therapy with relapse prevention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 38 participants
- Where
- 1 siteSweden
- Study dates
- 15 Mar 2020to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
Who cannot join
- not adequately fluent in Swedish; drug use; suicidality; indications of excessive use of the internet and computer gaming and/or gambling;
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Alcohol Use Disorder, Alcohol Abuse
- Being tested
- Internet-based cognitive behavioural treatment and relapse prevention, Face-to-face cognitive behavioural treatment or short-term psycodynamic therapy with relapse prevention
- Keywords
- Problematic alcohol use, Work life, Cognitive Behavior Therapy, Feasibility, Outcome, Employee assistance program, Internet, qualitative, quantitative
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based cognitive behavioural treatment and relapse preventionBehavioural
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 preventionBehavioural
Face-to-face therapy with a licenced psychologist or licenced psychotherapist, including 10-15 sessions.
| Study group | Role | What they receive |
|---|---|---|
| ICBT | Internet-based cognitive behaviour treatment, based on relapse prevention, delivered in a work-life setting. Receives: 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. Receives: Behavioral: Face-to-face cognitive behavioural treatment or short-term psycodynamic therapy with relapse prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Line Follow Back (TLFB)
Change in total TLFB score (consumption during preceding week), as a summarized measure of alcohol consumption
Measured: Baseline and 14 weeks, 6 months, 12 months and
Secondary outcomes (4)
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)
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and 14 weeks, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start15 Mar 2020
- Primary completion31 Dec 2023
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stockholm University
- Sponsor type
- University, hospital or other
- Collaborators
- AFA Insurance, Systembolagets alkoholforskningsråd, Alna Sverige AB, Karolinska Institutet, Uppsala University
- Responsible party
- Principal investigator, Kristina Sundqvist, Stockholm University
- Investigators
- Kristina Sundqvist, PhD, Principal investigator, Stockholm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774716
- Sponsor's protocol ID
- 1800008
- Acronym
- Simba
- Status last verified
- Jan 2025
- First submitted
- 10 May 2022
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06774716
- Acronym / sponsor ID
- Simba / 1800008
- Conditions
- Alcohol Use Disorder, Alcohol Abuse
- Keywords
- Problematic alcohol use, Work life, Cognitive Behavior Therapy, Feasibility, Outcome, Employee assistance program, Internet, qualitative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Stockholm UniversityUniversity, hospital or other
- Collaborators
- AFA Insurance, Systembolagets alkoholforskningsråd, Alna Sverige AB, Karolinska Institutet, Uppsala University
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICBT | – | Behavioral: Internet-based cognitive behavioural treatment and relapse preventionInternet-based cognitive behaviour treatment, based on relapse prevention, delivered in a work-life setting. |
| Face-to-face treatment as ususal | – | Behavioral: Face-to-face cognitive behavioural treatment or short-term psycodynamic therapy with relapse preventionFace-to-face treatment as usual, based on relapse prevention, delivered in a work-life setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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;
Key exclusion criteria (1 listed)
- not adequately fluent in Swedish; drug use; suicidality; indications of excessive use of the internet and computer gaming and/or gambling;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based cognitive behavioural treatment and relapse preventionA self help program consisting of 12 modules and access to therapist guidance through messages. Including three video session. | Behavioural | ICBT |
| Face-to-face cognitive behavioural treatment or short-term psycodynamic therapy with relapse preventionFace-to-face therapy with a licenced psychologist or licenced psychotherapist, including 10-15 sessions. | Behavioural | Face-to-face treatment as ususal |
Primary outcome
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
4 secondary outcomes
Alcohol Use Disorders Identification Test (AUDIT)
Time frame: Baseline and 14 weeks, 6 months, 12 months
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline and 14 weeks, 6 months, 12 months
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline and 14 weeks, 6 months, 12 months
The WHO-5 well-being-index
Time frame: Baseline and 14 weeks, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina Sundqvist, PhD principal investigator
Stockholm University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Use Disorder and Alcohol Abuse, run by Stockholm University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Line Follow Back (TLFB) (time frame: Baseline and 14 weeks, 6 months, 12 months and). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.