Treatment of Alcohol Problems in the Elderly

October 26, 2021 updated by: Kjeld Andersen

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

704

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Unit if Clinical Alcohol Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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:

    1. 7 or less correct answers in the "inclusion quiz" - indicating cognitive problems or not fully understanding the implications of participating in the study.
    2. Psychotic disorder with positive and/or negative symptoms
    3. Severe depression at time of inclusion
    4. Bipolar disorder
    5. Suicidal thoughts/behaviour at time of inclusion
    6. 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)
    7. Participating or have participated in other alcohol treatment programs within the last 30 days of inclusion. Pure detoxifications are not an exclusion criteria
    8. Clients with legally authorized representatives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: MET
Motivational Enhancement Therapy (MET)
Behavioral: MET + CRA
Other Names:
  • Motivational Enhancement Therapy (MET)
  • with subsequent add-on The Community Reinforcement Approach (CRA)
OTHER: MET + CRA
Motivational Enhancement Therapy (MET) with subsequent add-on The Community Reinforcement Approach (CRA)
Behavioral: MET + CRA
Other Names:
  • Motivational Enhancement Therapy (MET)
  • with subsequent add-on The Community Reinforcement Approach (CRA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol consumption 26 weeks after baseline
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abstinence or controlled use of alcohol
Time Frame: 4 weeks after baseline

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)
4 weeks after baseline
Abstinence or controlled use of alcohol
Time Frame: 12 weeks after baseline

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
12 weeks after baseline
Abstinence or controlled use of alcohol
Time Frame: 52 weeks after baseline

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
52 weeks after baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Quality of life
Time Frame: 52 weeks after baseline
Quality of life measured by WHO QOL BREF and Personal Happiness Form
52 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kjeld Andersen

Collaborators

University of New Mexico
Addiction Research Unit, Technische Universität, Dresden, Germany
Institut für Therapieforschung, München, Germany

Investigators

  • Principal Investigator: Kjeld Andersen, MD PhD, University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2014

Primary Completion (ACTUAL)

June 1, 2017

Study Completion (ACTUAL)

October 1, 2017

Study Registration Dates

First Submitted

March 7, 2014

First Submitted That Met QC Criteria

March 10, 2014

First Posted (ESTIMATE)

March 11, 2014

Study Record Updates

Last Update Posted (ACTUAL)

November 3, 2021

Last Update Submitted That Met QC Criteria

October 26, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESCueH-Elderly

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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