Alcohol Use DisorderBLEND-ANCT04535258
Blended Treatment for Alcohol Use Disorder
A study testing Blend-A in people with Alcohol Use Disorder, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
Blended Treatment for Alcohol Use Disorder (BLEND-A) is a pragmatic, cluster randomized controlled trial to assess the clinical effectiveness and cost-effectiveness of implementing a blended treatment format that aims to reduce problematic alcohol use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Blend-A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2020to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Legal person seeking public alcohol treatment in the participating municipalities.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blended Treatment for Alcohol Use Disorder - The BLEND-A Study Evaluation of a Blended Treatment Intervention for Alcohol Use Disorder in Denmark
Blended Treatment for Alcohol Use Disorder (BLEND-A) is a pragmatic, cluster randomized controlled trial to assess the clinical effectiveness and cost-effectiveness of implementing a blended treatment format that aims to reduce problematic alcohol use. Blended treatment is a treatment format where treatment as usual is offered as a combination of online and face-to-face sessions, integrated into one treatment protocol. The BLEND-A study will evaluate and implement a blended treatment program in routine alcohol addiction treatment. The trial is led by Unit of Clinical Alcohol Research, University of Southern Denmark (UCAR) in collaboration with partners at the Centre for Telepsychiatry in the Region of Southern Denmark (CTP), and Sundhed.dk.
Read the detailed description
Background: A major challenge to psychological treatment for Alcohol Use Disorder (AUD) is patient non-compliance. A promising new treatment approach that is hypothesized to increase treatment compliance is blended treatment, consisting of face-to-face contact with a therapist combined with modules delivered over the Internet within the same protocol. While this treatment concept has been developed and proven effective for a variety of mental disorders, it has not yet been examined for AUD.
Aims: The study described in this protocol aims to examine and evaluate patient compliance with blended AUD treatment as well as the clinical and cost effectiveness of such treatment compared to face-to-face treatment only.
Methods: The study design is a pragmatic, stepped-wedge cluster randomized controlled trial. The included outpatient institutions (planned number of patients: n=1800) will be randomized in clusters to implement either blended AUD treatment or face-to-face treatment only, i.e. treatment as usual (TAU). Both treatment approaches consist of motivational interviewing and cognitive behavioral therapy. Data on socio-demographics, alcohol consumption, addiction severity, treatment retention, treatment duration and intensity, and type of conclusion of treatment (dropout vs. compliance), will be retrieved from the National Register of Alcohol Treatment (NAB). In addition, all patients will be assessed for alcohol consumption, consequences of drinking and quality of life at treatment entry and six months after treatment conclusion. Data will be analyzed with an Intention-to-treat approach by means of generalized mixed models with random effect for cluster and fixed effect for each step. Also, analyses evaluating cost-effectiveness will be conducted.
Discussion: Blended treatment may increase treatment compliance and thus improve treatment outcomes due to increased flexibility of the treatment course. Since this study is conducted within an implementation framework it can easily be scaled up, and blended treatment has the potential to become an alternative offer in the majority ofmany outpatient clinics nationwide.
- Conditions
- Alcohol Use Disorder
- Being tested
- Blend-A
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blend-ADevice
Treatment for alcohol use disorders will be offered also as an internet-based option.
| Study group | Role | What they receive |
|---|---|---|
| First-movers | Other | The first four alcohol clinics offers internet-based treatment to the patients who chooses the proportion of internet-based sessions. Receives: Device: Blend-A |
| Second-movers | Other | After three months, the next five alcohol clinics offers internet-based treatment to the patients who chooses the proportion of internet-based sessions. Receives: Device: Blend-A |
| Third-movers | Other | After three months, the next five alcohol clinics offers internet-based treatment to the patients who chooses the proportion of internet-based sessions. Receives: Device: Blend-A |
| Fourth-movers | Other | After three months, the last four alcohol clinics offers internet-based treatment to the patients who chooses the proportion of internet-based sessions. Receives: Device: Blend-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance and premature dropout in alcohol treatment
BLEND-A (outpatient treatment as usual offered as a combination between face-to face and internet-based sessions) leads to a change in compliance in treatment during one year following initiation of treatment, compared to TAU (usual treatment delivered as face-to-face outpatient treatment only ), and measured as a change in premature dropout of treatment in the National Register of alcohol treatment (NAB).
Measured: One year after enrolled in the study
Effectiveness of alcohol treatment
The effectiveness of BLEND-A compared to TAU, measured by alcohol intake 6 months after treatment start. The alcohol intake is measured by self-reported alcohol intake.
Measured: 6 months after enrolled in the study
Secondary outcomes (3)
Differences in Quality of Life according to the intervention
BLEND-A leads to a change in quality of life (measured by means of Patient Reported Outcomes (PRO)) among patients, compared to face-to-face outpatient treatment as usual, measured 6 months after treatment start.
Measured: 6 months after enrolled in the study
Which part of treatment is appreciated to receive via the internet
Based on the user data from BLEND-A, we expect to be able to determine what part of the usual treatment that is appreciated to receive via the internet.
Measured: Through study completion, an average of 1 year
Optimal blend
Based on the user data from BLEND-A, we expect to be able to determine the optimal combination of face-to-face and internet-based sessions.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start1 Jun 2020
- Primary completion30 Jun 2022
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped-wedge cluster randomized (18 institutions, 4 waves)
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark
- Responsible party
- Sponsor
- Investigators
- Anette S. Nielsen, PhD, Study director, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535258
- Sponsor's protocol ID
- BLEND-A
- Acronym
- BLEND-A
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2020
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tarp K, Christiansen R, Bilberg R, Borkner S, Dalsgaard C, Paldam Folker M, Sogaard Nielsen A. Patient Perspectives on Blended Internet-Based and Face-to-Face Cognitive Behavioral Therapy for Alcohol Use Disorder: Qualitative Study. J Med Internet Res. 2024 Oct 23;26:e47083. doi: 10.2196/47083.
PubMed 39441642Mellentin AI, Behrendt S, Bilberg R, Blankers M, Folker MP, Tarp K, Uffelmann J, Nielsen AS. BLEND-A: blending internet treatment into conventional face-to-face treatment for alcohol use disorder - a study protocol. BMC Psychiatry. 2021 Mar 6;21(1):131. doi: 10.1186/s12888-021-03122-4.
PubMed 33676429
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blended Treatment for Alcohol Use Disorder - The BLEND-A Study Evaluation of a Blended Treatment Intervention for Alcohol Use Disorder in Denmark
- ClinicalTrials.gov ID
- NCT04535258
- Acronym / sponsor ID
- BLEND-A / BLEND-A
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Region of Southern Denmark
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Sep 2020 (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.
Blended Treatment for Alcohol Use Disorder (BLEND-A) is a pragmatic, cluster randomized controlled trial to assess the clinical effectiveness and cost-effectiveness of implementing a blended treatment format that aims to reduce problematic alcohol use. Blended treatment is a treatment format where treatment as usual is offered as a combination of online and face-to-face sessions, integrated into one treatment protocol. The BLEND-A study will evaluate and implement a blended treatment program in routine alcohol addiction treatment. The trial is led by Unit of Clinical Alcohol Research, University of Southern Denmark (UCAR) in collaboration with partners at the Centre for Telepsychiatry in the Region of Southern Denmark (CTP), and Sundhed.dk.
Detailed description
Background: A major challenge to psychological treatment for Alcohol Use Disorder (AUD) is patient non-compliance. A promising new treatment approach that is hypothesized to increase treatment compliance is blended treatment, consisting of face-to-face contact with a therapist combined with modules delivered over the Internet within the same protocol. While this treatment concept has been developed and proven effective for a variety of mental disorders, it has not yet been examined for AUD.
Aims: The study described in this protocol aims to examine and evaluate patient compliance with blended AUD treatment as well as the clinical and cost effectiveness of such treatment compared to face-to-face treatment only.
Methods: The study design is a pragmatic, stepped-wedge cluster randomized controlled trial. The included outpatient institutions (planned number of patients: n=1800) will be randomized in clusters to implement either blended AUD treatment or face-to-face treatment only, i.e. treatment as usual (TAU). Both treatment approaches consist of motivational interviewing and cognitive behavioral therapy. Data on socio-demographics, alcohol consumption, addiction severity, treatment retention, treatment duration and intensity, and type of conclusion of treatment (dropout vs. compliance), will be retrieved from the National Register of Alcohol Treatment (NAB). In addition, all patients will be assessed for alcohol consumption, consequences of drinking and quality of life at treatment entry and six months after treatment conclusion. Data will be analyzed with an Intention-to-treat approach by means of generalized mixed models with random effect for cluster and fixed effect for each step. Also, analyses evaluating cost-effectiveness will be conducted.
Discussion: Blended treatment may increase treatment compliance and thus improve treatment outcomes due to increased flexibility of the treatment course. Since this study is conducted within an implementation framework it can easily be scaled up, and blended treatment has the potential to become an alternative offer in the majority ofmany outpatient clinics nationwide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Stepped-wedge cluster randomized (18 institutions, 4 waves)
| Arm | Type | Receives |
|---|---|---|
| First-movers | Other | Device: Blend-AThe first four alcohol clinics offers internet-based treatment to the patients who chooses the proportion of internet-based sessions. |
| Second-movers | Other | Device: Blend-AAfter three months, the next five alcohol clinics offers internet-based treatment to the patients who chooses the proportion of internet-based sessions. |
| Third-movers | Other | Device: Blend-AAfter three months, the next five alcohol clinics offers internet-based treatment to the patients who chooses the proportion of internet-based sessions. |
| Fourth-movers | Other | Device: Blend-AAfter three months, the last four alcohol clinics offers internet-based treatment to the patients who chooses the proportion of internet-based sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Legal person seeking public alcohol treatment in the participating municipalities.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Blend-ATreatment for alcohol use disorders will be offered also as an internet-based option. | Device | First-movers, Fourth-movers, Second-movers, Third-movers |
Primary outcome
Compliance and premature dropout in alcohol treatment
Time frame: One year after enrolled in the study
BLEND-A (outpatient treatment as usual offered as a combination between face-to face and internet-based sessions) leads to a change in compliance in treatment during one year following initiation of treatment, compared to TAU (usual treatment delivered as face-to-face outpatient treatment only ), and measured as a change in premature dropout of treatment in the National Register of alcohol treatment (NAB).
Effectiveness of alcohol treatment
Time frame: 6 months after enrolled in the study
The effectiveness of BLEND-A compared to TAU, measured by alcohol intake 6 months after treatment start. The alcohol intake is measured by self-reported alcohol intake.
3 secondary outcomes
Differences in Quality of Life according to the intervention
Time frame: 6 months after enrolled in the study
Which part of treatment is appreciated to receive via the internet
Time frame: Through study completion, an average of 1 year
Optimal blend
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Derived from this study: PubMed 39441642Tarp K, Christiansen R, Bilberg R, Borkner S, Dalsgaard C, Paldam Folker M, Sogaard Nielsen A. Patient Perspectives on Blended Internet-Based and Face-to-Face Cognitive Behavioral Therapy for Alcohol Use Disorder: Qualitative Study. J Med Internet Res. 2024 Oct 23;26:e47083. doi: 10.2196/47083.
- Derived from this study: PubMed 33676429Mellentin AI, Behrendt S, Bilberg R, Blankers M, Folker MP, Tarp K, Uffelmann J, Nielsen AS. BLEND-A: blending internet treatment into conventional face-to-face treatment for alcohol use disorder - a study protocol. BMC Psychiatry. 2021 Mar 6;21(1):131. doi: 10.1186/s12888-021-03122-4.
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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.
Anette S. Nielsen, PhD study director
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blend-A in people with Alcohol Use Disorder, run by University of Southern Denmark at 1 site in Denmark.
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: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
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?
Compliance and premature dropout in alcohol treatment (time frame: One year after enrolled in the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04535258, which also lists 2 linked publications.
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 29 Apr 2026; AzTrials last refreshed its copy on 3 Nov 2026.