Treatment of Alcohol Problems in the Elderly
Primary Purpose
Alcohol Use Disorders
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
MET + CRA
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorders focused on measuring alcohol, 60+ years, treatment, met, cra, multi site, multi country, questionnaire, random
Eligibility Criteria
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will receive the standard treatment offered by the treatment clinic, an acceptance of participating can always be withdrawn.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:
- 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
- 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
Sites / Locations
- Unit if Clinical Alcohol Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
MET
MET + CRA
Arm Description
Motivational Enhancement Therapy (MET)
Motivational Enhancement Therapy (MET) with subsequent add-on The Community Reinforcement Approach (CRA)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
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‰)
In the last 7 days before planned termination of MET + CRA
Participants in MET only, will also be measured
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‰)
Since 26 weeks follow-up
In the last 30 days at 52 weeks follow-up
Full Information
NCT ID
NCT02084173
First Posted
March 7, 2014
Last Updated
October 26, 2021
Sponsor
Kjeld Andersen
Collaborators
University of New Mexico, Addiction Research Unit, Technische Universität, Dresden, Germany, Institut für Therapieforschung, München, Germany
1. Study Identification
Unique Protocol Identification Number
NCT02084173
Brief Title
Treatment of Alcohol Problems in the Elderly
Official Title
Motivational Enhancement Therapy and Community Reinforcement Approach For Treating Alcohol Problems in the Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kjeld Andersen
Collaborators
University of New Mexico, Addiction Research Unit, Technische Universität, Dresden, Germany, Institut für Therapieforschung, München, Germany
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorders
Keywords
alcohol, 60+ years, treatment, met, cra, multi site, multi country, questionnaire, random
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
704 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MET
Arm Type
Other
Arm Description
Motivational Enhancement Therapy (MET)
Arm Title
MET + CRA
Arm Type
Other
Arm Description
Motivational Enhancement Therapy (MET) with subsequent add-on The Community Reinforcement Approach (CRA)
Intervention Type
Behavioral
Intervention Name(s)
MET + CRA
Other Intervention Name(s)
Motivational Enhancement Therapy (MET), with subsequent add-on The Community Reinforcement Approach (CRA)
Primary Outcome Measure Information:
Title
Alcohol consumption 26 weeks after baseline
Description
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
Time Frame
26 weeks after baseline
Secondary Outcome Measure Information:
Title
Abstinence or controlled use of alcohol
Description
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)
Time Frame
4 weeks after baseline
Title
Abstinence or controlled use of alcohol
Description
Percentage of patients with abstinence or controlled use (maximum daily alcohol intake of an equivalent of BAC 0.5‰)
In the last 7 days before planned termination of MET + CRA
Participants in MET only, will also be measured
Time Frame
12 weeks after baseline
Title
Abstinence or controlled use of alcohol
Description
Percentage of patients with abstinence or controlled use (maximum daily alcohol intake of an equivalent of BAC 0.5‰)
Since 26 weeks follow-up
In the last 30 days at 52 weeks follow-up
Time Frame
52 weeks after baseline
Other Pre-specified Outcome Measures:
Title
Changes in Quality of life
Description
Quality of life measured by WHO QOL BREF and Personal Happiness Form
Time Frame
52 weeks after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjeld Andersen, MD PhD
Organizational Affiliation
University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit if Clinical Alcohol Research
City
Odense
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
34585747
Citation
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.
Results Reference
derived
PubMed Identifier
34282079
Citation
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.
Results Reference
derived
PubMed Identifier
33860951
Citation
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.
Results Reference
derived
PubMed Identifier
33496964
Citation
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.
Results Reference
derived
PubMed Identifier
33138927
Citation
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.
Results Reference
derived
PubMed Identifier
31454444
Citation
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.
Results Reference
derived
PubMed Identifier
26573323
Citation
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.
Results Reference
derived
Links:
URL
http://www.sdu.dk/en/om_sdu/institutter_centre/ucar
Description
Homepage of the RESCueH unit
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Treatment of Alcohol Problems in the Elderly
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