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Alcohol Use DisordersNCT02084173

Treatment of Alcohol Problems in the Elderly

A study testing MET + CRA in people with Alcohol Use Disorders, run by Kjeld Andersen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Alcohol Use Disorders
What is being tested?
MET + CRA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
704 participants
Where
1 siteDenmark
Study dates
Jan 2014to Oct 2017
Phase
Interventional
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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Seniors (+60 years) with alcohol use disorders according to DSM 5
  • Passing an "inclusion quiz" based on 10 questions pertaining to the implications of participating in the study, e.g. knowledge about that it is voluntary to participate, a person declining to participate will receive the standard treatment offered by the treatment clinic, an acceptance of participating can always be withdrawn. The quiz will be conducted after informed consent, and be in a multiple-choice format.

Who cannot join

  • 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:
  • 7 or less correct answers in the "inclusion quiz" - indicating cognitive problems or not fully understanding the implications of participating in the study.
  • Psychotic disorder with positive and/or negative symptoms
  • Severe depression at time of inclusion
  • Bipolar disorder
  • Suicidal thoughts/behaviour at time of inclusion
Show all 9Show fewer
  • 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)
  • Participating or have participated in other alcohol treatment programs within the last 30 days of inclusion. Pure detoxifications are not an exclusion criteria
  • Clients with legally authorized representatives

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Unit if Clinical Alcohol Research

    Odense, 5000

Other trials in Denmark

About this study

Official title: Motivational Enhancement Therapy and Community Reinforcement Approach For Treating Alcohol Problems in the Elderly

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.

Read more

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.

Being tested
MET + CRA
Keywords
alcohol, 60+ years, treatment, met, cra, multi site, multi country, questionnaire, random
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MET + CRABehavioural

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

Study groups in NCT02084173
Study groupRoleWhat they receive
METOtherMotivational Enhancement Therapy (MET)
Receives: Behavioral: MET + CRA
MET + CRAOtherMotivational Enhancement Therapy (MET) with subsequent add-on The Community Reinforcement Approach (CRA)
Receives: Behavioral: MET + CRA

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 26 weeks after baseline

Secondary outcomes (3)

  1. Abstinence or controlled use of alcohol

    Percentage of patients with abstinence or controlled use (maximum daily alcohol intake of an equivalent of BAC 0.5‰)

    1. In the last 7 days before planned termination of treatment (MET)

    Measured: 4 weeks after baseline

  2. Abstinence or controlled use of alcohol

    Percentage of patients with abstinence or controlled use (maximum daily alcohol intake of an equivalent of BAC 0.5‰)

    1. In the last 7 days before planned termination of MET + CRA
    2. Participants in MET only, will also be measured

    Measured: 12 weeks after baseline

  3. Abstinence or controlled use of alcohol

    Percentage of patients with abstinence or controlled use (maximum daily alcohol intake of an equivalent of BAC 0.5‰)

    1. Since 26 weeks follow-up
    2. In the last 30 days at 52 weeks follow-up

    Measured: 52 weeks after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionJun 2017
  4. Study completionOct 2017

Resources

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
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
704 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02084173
Sponsor's protocol ID
RESCueH-Elderly
Status last verified
Oct 2021
First submitted
7 Mar 2014
Last updated
3 Nov 2021
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 34585747

  • 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.

    PubMed 34282079

  • 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.

    PubMed 33860951

  • 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.

    PubMed 33496964

  • 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.

    PubMed 33138927

  • 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.

    PubMed 31454444

  • 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.

    PubMed 26573323

Questions about this trial

What is this clinical trial studying?

A study testing MET + CRA in people with Alcohol Use Disorders, run by Kjeld Andersen 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 2 inclusion and 9 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 3 Nov 2021. 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?

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?

Alcohol consumption 26 weeks after baseline (time frame: 26 weeks after baseline). 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 NCT02084173, which also lists 7 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 3 Nov 2021.

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