Short summary

Western societies, including Denmark, Germany, and the United States of America, have rapidly aging populations. This demographic change along with an increasing number of elderly with problematic alcohol consumption poses a major health care problem in years to come.

The purpose of this international study is to develop and test an outpatient behavior therapy program for alcohol use disorders for seniors (>age 60) in 1000 patients. The study started in January 2014 with enrolled patients and end in December 2015. The results of the study are starting publish in the beginning of 2017 and forward.

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Rationale

Western societies, including Denmark, Germany, and the United States of America, have rapidly aging populations. This demographic change along with an increasing number of elderly with problematic alcohol consumption poses a major health care problem in years to come. Knowledge about treatment of elderly with problematic alcohol consumption is essential, but there are no strong evidence-based treatment methods for this particular subpopulation.

The purpose of this study is to develop and test an outpatient behavior therapy program for alcohol use disorders for seniors (age 60 or older), which, if effective, can be easily implemented in routine care. Three centers from Denmark, Germany and USA (New Mexico) participate. All three centers have a long and extensive experience with alcohol treatment and alcohol research.

The study is conducted as a multi-center blinded, randomized, controlled trial. Patients from the outpatient clinics in Copenhagen, Aarhus and Odense (Denmark), Munich and Dresden (Germany), and Albuquerque, New Mexico (USA), with a desire for treatment for alcohol problems are offered to participate in the study if they meet all of the below inclusion criterias: Seniors with alcohol use disorders according to DSM-IV. A total of 1,000 patients will be enrolled: 400 patients from Denmark, 400 from Germany, and 200 from USA. Upon written and oral consent, baseline interviews are carried out. Then the clients are randomized to MET or MET+CRA.

 

Motivational Enhancement Therapy (MET)

MET is a short brief intervention (4 sessions, 1 session per week. This intervention will be exactly the same in both treatment arms), which aims to evoke rapid and internally motivated change, rather than guide the patient stepwise through the recovery process. This may be a prudent and sufficient approach for the elderly, thus the psychosocial consequences of alcohol abuse in this population is not as severe as in younger alcoholics. Most are late-onset alcoholics, and the severity of the abuse is less pronounced.

 

The Community Reinforcement Approach (CRA)

CRA can be a relatively short intervention (8 weeks, 1 session per week). CRA aims to achieve abstinence by eliminating "positive" reinforcement for drinking and enhancing positive reinforcement for sobriety. CRA integrates several treatment components, including building the client's motivation to quit drinking, helping the client initiate sobriety, analyzing the client's drinking pattern, increasing positive reinforcement, learning new coping behaviors, and involving significant others in the recovery process. This seems a good match for an elderly population group, thus the loss of sources of positive reinforcement is a significant life transition as people age. We will therefore adapt CRA to specifically target the needs and challenges of the elderly.

This study will provide new insight into treatment of a rapidly growing patient group, thereby improving the prognosis of this patient group and potentially significantly reduce the number of elderly with alcohol problems. This is to the benefit both of patients at an individual level, but also of the health care system and society as a whole.

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Description of the cohort

Seniors (>60 years) with alcohol use disorders according to DSM-IV are included in the Elderly-study. They will all be enrolled from department or clinics of outpatients in Copenhagen, Aarhus and Odense (Denmark), Munich and Dresden (Germany), and Albuquerque, New Mexico (USA).

Data and biological material

OPEN's data manager develop electronic schemes for data entry, data is imported and stored in OPEN Projects.

Data from baseline interviews and re-interviews at four weeks (end of MET treatment), 12 weeks (end of CRA treatment) and follow-up interviews at 6 and 12 months.

Data from the following instruments will be used for recruitment and during intervention

• Form-90
• Alcohol dependence scale
• Penn Alcohol Craving Scale 
• Self-efficacy: AASE, Alcohol Abstinence Self-Efficacy Scale
• Drinker Inventory of Consequences
• Personal Happiness Form
• Readiness Ruler for motivation 
• Mini International Neuropsychiatric Interview
• Charlson Co-mobidity Index
• WHO Quality of Life, Brief Form
• Brief Symptom Inventory 18 (BSI vers. 18)  
• What do you want from treatment
• Thoughts about abstinences

This will enable us to document the treatment effects, including the "active" elements in the treatments proposed in this protocol. That is, which part(s) of the treatments made the difference in outcome?

The following instruments will be re-administered at all follow-up points

• Form-90
• Penn Alcohol Craving Scale
• Self-efficacy: AASE, Alcohol Abstinence Self-Efficacy Scale
• Drinker Inventory of Consequences
• Personal Happiness Form
• Readiness Ruler for motivation 
• WHO Quality of Life, Brief Form
• Treatment Satisfaction
• Brief Symptom Inventory 18 (BSI vers. 18)

At follow-up, each participant will be interviewed about medical and psychiatric history since last interview, as well as on changes in socio-demographic characteristics (work, marital status, family and friends, hobbies and interests/including out-of-home activities), changes in medication.

At the 6 month follow-up hair samples will be collected from all participants, the samples are registered in the OPEN Projects database and stored in OPENs biobank.

Collaborating researchers and departments

Department of Psychiatry, Odense University Hospital/Research Unit of Psychiatry, University of Southern Denmark

• Professor, Chief Consultant and Head of Research Unit Bent Nielsen, MD, PhD
• Project Director and Assistant Professor Anette Søgaard Nielsen, PhD
• Professor Kjeld Andersen, MD, PhD
• Adjunct Randi Bilberg

Alcohol Treatment Center, Odense Municipal Alcohol Treatment Center, Aarhus Municipal

Alcohol Treatment Center, Copenhagen Municipal Department of Public Health, University of Copenhagen

• Professor Claus Ekstrøm

Faculty of Health, Aalborg University/Institute of Organization and Industrial Sociology, Copenhagen Business School

• Professor Jes Søgaard

Department of Addiction Research, Technische Universität Dresden, Germany/Institut für Therapieforschung (IFT), Munich, Germany

• Professor and Director Gerhard Buehringer

Department of Psychiatry, Health Science Center, University of New Mexico, US

• Professor Michael Bogenschutz, MD

University of New Mexico, US

• Associate Professor Teresa Moyers
• Office Director Roberta Chavez