Clinical trial NCT04535258: Blended Treatment for Alcohol Use Disorder
Official title: Blended Treatment for Alcohol Use Disorder - The BLEND-A Study Evaluation of a Blended Treatment Intervention for Alcohol Use Disorder in Denmark
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
First posted: 2020-09-01
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped-wedge cluster randomized (18 institutions, 4 waves)
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Legal person seeking public alcohol treatment in the participating municipalities.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Compliance and premature dropout in alcohol treatment
timeFrame: One year after enrolled in the study
measure: Effectiveness of alcohol treatment
timeFrame: 6 months after enrolled in the study
Secondary outcomes:
measure: Differences in Quality of Life according to the intervention
timeFrame: 6 months after enrolled in the study
measure: Which part of treatment is appreciated to receive via the internet
timeFrame: Through study completion, an average of 1 year
measure: Optimal blend
timeFrame: Through study completion, an average of 1 year
Other outcomes:
measure: Qualitative interviews
timeFrame: Through study completion, an average of 1 year
Locations:
city: Odense
country: Denmark
facility: Unit if Clinical Alcohol Research
Study officials:
affiliation: University of Southern Denmark
name: Anette S. Nielsen, PhD
role: STUDY_DIRECTOR
References:
citation: Mellentin 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.