Clinical trial NCT01291693: Testing Delivery Channels of Brief Motivational Alcohol Intervention
Official title: Testing Delivery Channels of Brief Motivational Alcohol Intervention Among General Hospital Inpatients With Risky Drinking: Personal Counseling Versus Computer-generated Feedback Letters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hazardous Drinking
Keywords: Hazardous drinking
general hospital
brief intervention
Motivational Interviewing
computer-generated feedback
stage-tailored
delivery channel
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: German Cancer Aid
First posted: 2011-02-08
Enrollment: 975
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate whether motivation-tailored alcohol interventions are more effective when delivered by person or by computer-generated feedback letters. A sample of 920 general hospital inpatients with risky drinking will be recruited through a computerized screening procedure. Patients with more severe alcohol problems will be excluded from the study. Participants will be allocated by time frame randomization to one of three study arms: (1) personal counseling based on Motivational Interviewing, (2) computer-expert system intervention that generates individualized feedback-letters, and (3) control group (treatment-as-usual). The interventions differ in their channel of delivery, but not regarding their content. Both intervention groups receive interventions at three time points: directly after the baseline-assessment at the general hospital, and 1 and 3 months later by mail and phone, respectively. Outcome will be assessed six, 12, 18 and 24 months after baseline.


Eligibility criteria: Inclusion Criteria:

* General hospital inpatients with risky drinking (AUDIT-C \>= 4/5 (women/men) and AUDIT \< 20)

Exclusion Criteria:

* Patients already recruited during an earlier hospital stay
* Patients physically and mentally not capable of participating in the study
* Patients with a hospital stay of less than 24 hours
* Patients with insufficient language/ reading skills
* Patients employed at one of the departments participating in the study or conducting the study
* Patients with more severe alcohol problems (AUDIT \>= 20)

Primary outcomes:
measure: Risky drinking
timeFrame: 6, 12, 18, 24 months
Secondary outcomes:
measure: Motivation to reduce drinking
timeFrame: 6, 12, 18, 24 months
measure: Attempts to reduce drinking
timeFrame: 6, 12, 18, 24 months
measure: Knowledge about drinking limits
timeFrame: 6, 12, 18, 24 months
measure: Self-efficacy scores
timeFrame: 6 months
measure: Decisional balance scores
timeFrame: 6 months
measure: Self-rated health
timeFrame: 6, 12, 18, 24 months
measure: Health care utilization
timeFrame: 6, 12, 18, 24 months
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Institute of Social Medicine and Prevention, University Medicine Greifswald
state: Mecklenburg-Western Pomerania
Study officials:
affiliation: Institute of Social Medicine and Prevention, University Medicine Greifswald
name: Jennis Freyer-Adam, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Epidemiology and Health Monitoring, Robert Koch-Institute Berlin
name: Beate Gaertner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Social Medicine and Prevention, University Medicine Greifswald
name: Ulrich John, Prof PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Freyer-Adam J, Baumann S, Bischof G, Staudt A, Goeze C, Gaertner B, John U. Social Equity in the Efficacy of Computer-Based and In-Person Brief Alcohol Interventions Among General Hospital Patients With At-Risk Alcohol Use: A Randomized Controlled Trial. JMIR Ment Health. 2022 Jan 28;9(1):e31712. doi: 10.2196/31712.
citation: Freyer-Adam J, Noetzel F, Baumann S, Aghdassi AA, Siewert-Markus U, Gaertner B, John U. Behavioral health risk factor profiles in general hospital patients: identifying the need for screening and brief intervention. BMC Public Health. 2019 Nov 29;19(1):1594. doi: 10.1186/s12889-019-7931-6.
citation: Freyer-Adam J, Baumann S, Haberecht K, Tobschall S, Bischof G, John U, Gaertner B. In-person alcohol counseling versus computer-generated feedback: Results from a randomized controlled trial. Health Psychol. 2018 Jan;37(1):70-80. doi: 10.1037/hea0000556. Epub 2017 Oct 2.
citation: Baumann S, Gaertner B, Haberecht K, Meyer C, Rumpf HJ, John U, Freyer-Adam J. Does impaired mental health interfere with the outcome of brief alcohol intervention at general hospitals? J Consult Clin Psychol. 2017 Jun;85(6):562-573. doi: 10.1037/ccp0000201. Epub 2017 Mar 23.