NCT02084173

Brief Summary

With the aging of western societies in the coming years combined with increasing alcohol consumption among elderly, the number of elderly with alcohol problems is expected to rise considerably. Elderly patients are often lonely; suffer from feelings of loss, fear to be a burden on their children and on society, and feel powerless. On the surface their alcohol related problems seem less severe that those of the middle-aged patients while in reality co-morbidity and social issues complicate alcohol dependency. Currently, no specific treatment tailored for alcohol use disorder among elderly is available. Consequently they receive either no treatment, are given brief advising from the general practitioner or are referred to treatment at specialized treatment institutions with no specific treatment for elderly. The investigators propose a study aimed at developing and testing an outpatient behavior therapy program for alcohol use disorders for seniors (60 years and older), which - if effective - can be easily implemented in routine care. Three centers from Denmark, Germany and USA (New Mexico) will participate. All three centers have a long and extensive experience with alcohol treatment and alcohol research. Patients fulfilling the DSM 5 criteria for alcohol use disorder are eligible for the study. After informed consent participants will be randomly assigned to either Motivational Enhancement Therapy (MET), four sessions/one session per week or MET followed by Community Re-enforcement Approach (CRA), eight sessions/one session per week - thus 12 weeks of treatment in total. 50% will receive MET and 50% MET+CRA. Primary outcome is percentage of patients with abstinence or controlled use (alcohol intake of equivalent blood alcohol content equal to or less than 0.5‰.). A total of 1000 patients will be enrolled. Participants will be assessed with a battery of international validated instruments measuring drinking pattern as well as key elements of treatment. Participants are assessed before initiation of treatment, at the end of MET treatment (four weeks), at the end of MET+CRA treatment (12 weeks), at 6 months, and at 12 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
704

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

November 3, 2021

Status Verified

October 1, 2021

Enrollment Period

3.4 years

First QC Date

March 7, 2014

Last Update Submit

October 26, 2021

Conditions

Alcohol Use Disorders

Keywords

alcohol60+ yearstreatmentmetcramulti sitemulti countryquestionnairerandom

Outcome Measures

Primary Outcomes (1)

  • Alcohol consumption 26 weeks after baseline

    Percentage of patients with abstinence or controlled use (daily alcohol intake equivalent to a BAC equal to or less than 0.5‰) in the last 30 days at 26 weeks after start of treatment. Measured by Form90

    26 weeks after baseline

Secondary Outcomes (3)

  • Abstinence or controlled use of alcohol

    4 weeks after baseline

  • Abstinence or controlled use of alcohol

    12 weeks after baseline

  • Abstinence or controlled use of alcohol

    52 weeks after baseline

Other Outcomes (1)

  • Changes in Quality of life

    52 weeks after baseline

Study Arms (2)

MET

OTHER

Motivational Enhancement Therapy (MET)

Behavioral: MET + CRA

MET + CRA

OTHER

Motivational Enhancement Therapy (MET) with subsequent add-on The Community Reinforcement Approach (CRA)

Behavioral: MET + CRA

Interventions

MET + CRABEHAVIORAL
Also known as: Motivational Enhancement Therapy (MET), with subsequent add-on The Community Reinforcement Approach (CRA)
METMET + CRA

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Seniors (+60 years) with alcohol use disorders according to DSM 5

You may not qualify if:

  • We strive for ecological validity and will only exclude patients who are unable to participate in the therapy or are suffering from severe conditions judged to risking the validity of the study:
  • Psychotic disorder with positive and/or negative symptoms
  • Bipolar disorder
  • Use of illicit opioids and/or illicit stimulants (all other forms of medication is allowed, including opioids on prescription - they will be recorded and may be included as covariates in the analyses)
  • Clients with legally authorized representatives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit if Clinical Alcohol Research

Odense, 5000, Denmark

Location

Related Publications (7)

  • Behrendt S, Kuerbis A, Braun-Michl B, Bilberg R, Buhringer G, Bogenschutz M, Mejldal A, Andersen K, Sogaard Nielsen A. Residual alcohol use disorder symptoms after treatment predict long-term drinking outcomes in seniors with DSM-5 alcohol use disorder. Alcohol Clin Exp Res. 2021 Nov;45(11):2396-2405. doi: 10.1111/acer.14722. Epub 2021 Oct 9.

    PMID: 34585747DERIVED

  • Behrendt S, Kuerbis A, Mejldal A, Braun-Michl B, Bilberg R, Bu Hringer G, Bogenschutz M, Nielsen AS, Andersen K. The Prognostic Role of DSM-5 Alcohol Use Disorder Severity and Age of Onset in Treatment Outcome Among Adults Aged 60. J Addict Med. 2022 May-Jun 01;16(3):303-309. doi: 10.1097/ADM.0000000000000892.

    PMID: 34282079DERIVED

  • Mejldal A, Andersen K, Behrendt S, Bilberg R, Christensen AI, Lau CJ, Moller S, Nielsen AS. History of healthcare use and disease burden in older adults with different levels of alcohol use. A register-based cohort study. Alcohol Clin Exp Res. 2021 Jun;45(6):1237-1248. doi: 10.1111/acer.14615. Epub 2021 May 6.

    PMID: 33860951DERIVED

  • Mejldal A, Andersen K, Behrendt S, Bilberg R, Bogenschutz M, Braun-Michl B, Buhringer G, Sogaard Nielsen A. Stability of Posttreatment Reductions in World Health Organization (WHO) Drinking Risk Levels and Posttreatment Functioning in Older Adults with DSM-5 Alcohol Use Disorder: Secondary Data Analysis of the Elderly Study. Alcohol Clin Exp Res. 2021 Mar;45(3):638-649. doi: 10.1111/acer.14562. Epub 2021 Mar 3.

    PMID: 33496964DERIVED

  • Behrendt S, Kuerbis A, Bilberg R, Braun-Michl B, Mejldal A, Buhringer G, Bogenschutz M, Andersen K, Nielsen AS. Impact of comorbid mental disorders on outcomes of brief outpatient treatment for DSM-5 alcohol use disorder in older adults. J Subst Abuse Treat. 2020 Dec;119:108143. doi: 10.1016/j.jsat.2020.108143. Epub 2020 Oct 5.

    PMID: 33138927DERIVED

  • Andersen K, Behrendt S, Bilberg R, Bogenschutz MP, Braun B, Buehringer G, Ekstrom CT, Mejldal A, Petersen AH, Nielsen AS. Evaluation of adding the community reinforcement approach to motivational enhancement therapy for adults aged 60 years and older with DSM-5 alcohol use disorder: a randomized controlled trial. Addiction. 2020 Jan;115(1):69-81. doi: 10.1111/add.14795. Epub 2019 Nov 1.

    PMID: 31454444DERIVED

  • Andersen K, Bogenschutz MP, Buhringer G, Behrendt S, Bilberg R, Braun B, Ekstrom CT, Forcehimes A, Lizarraga C, Moyers TB, Nielsen AS. Outpatient treatment of alcohol use disorders among subjects 60+ years: design of a randomized clinical trial conducted in three countries (Elderly Study). BMC Psychiatry. 2015 Nov 14;15:280. doi: 10.1186/s12888-015-0672-x.

    PMID: 26573323DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Kjeld Andersen, MD PhD

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 7, 2014

First Posted

March 11, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2017

Study Completion

October 1, 2017

Last Updated

November 3, 2021

Record last verified: 2021-10

Locations

DK(1)