Clinical trial NCT02084173: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorders
Keywords: alcohol
60+ years
treatment
met
cra
multi site
multi country
questionnaire
random
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: University of New Mexico
name: Addiction Research Unit, Technische Universität, Dresden, Germany
name: Institut für Therapieforschung, München, Germany
First posted: 2014-03-11
Enrollment: 704
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

  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

Primary outcomes:
measure: Alcohol consumption 26 weeks after baseline
timeFrame: 26 weeks after baseline
Secondary outcomes:
measure: Abstinence or controlled use of alcohol
timeFrame: 4 weeks after baseline
measure: Abstinence or controlled use of alcohol
timeFrame: 12 weeks after baseline
measure: Abstinence or controlled use of alcohol
timeFrame: 52 weeks after baseline
Other outcomes:
measure: Changes in Quality of life
timeFrame: 52 weeks after baseline
Locations:
city: Odense
country: Denmark
facility: Unit if Clinical Alcohol Research
Study officials:
affiliation: University of Southern Denmark
name: Kjeld Andersen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.