Treatment of Alcohol Problems in the Elderly

Alcohol Use Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02084173
• Other study ID #: RESCueH-Elderly
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: October 2017

Study information

• Verified date: October 2021
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 704
• Est. completion date: October 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use Disorders
• Alcohol-Related Disorders
• Alcoholism

Intervention

Behavioral:
• MET + CRA

Locations

Country	Name	City	State
Denmark	Unit if Clinical Alcohol Research	Odense

Sponsors (4)

Lead Sponsor	Collaborator
Kjeld Andersen	Addiction Research Unit, Technische Universität, Dresden, Germany, Institut für Therapieforschung, München, Germany, University of New Mexico

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Quality of life	Quality of life measured by WHO QOL BREF and Personal Happiness Form	52 weeks after baseline
Primary	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	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
Secondary	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
Secondary	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

External Links

•   Homepage of the RESCueH unit