Treatment of Alcohol Problems in the Elderly

Study Overview
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Brief Summary
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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.

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

Conditions
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Alcohol Use Disorders

Intervention / Treatment
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* Behavioral: MET + CRA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MET<br>Motivational Enhancement Therapy (MET) | Behavioral: MET + CRA<br> <br> * Other names: with subsequent add-on The Community Reinforcement Approach (CRA);|
| Other: MET + CRA<br>Motivational Enhancement Therapy (MET) with subsequent add-on The Community Reinforcement Approach (CRA) | Behavioral: MET + CRA<br> <br> * Other names: with subsequent add-on The Community Reinforcement Approach (CRA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 4 weeks after baseline | 
| 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 | 12 weeks after baseline | 
| 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 | 52 weeks after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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met, random, cra, multi site, multi country, questionnaire, 60+ years, treatment, alcohol