NCT01291693

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
975

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 8, 2011

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

3.8 years

First QC Date

February 4, 2011

Last Update Submit

December 1, 2015

Conditions

Hazardous Drinking

Keywords

Hazardous drinkinggeneral hospitalbrief interventionMotivational Interviewingcomputer-generated feedbackstage-tailoreddelivery channel

Outcome Measures

Primary Outcomes (1)

  • Risky drinking

    Determined by using average alcohol consumption per day, heavy occasional drinking, highest blood alcohol concentration, the Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) score

    6, 12, 18, 24 months

Secondary Outcomes (7)

  • Motivation to reduce drinking

    6, 12, 18, 24 months

  • Attempts to reduce drinking

    6, 12, 18, 24 months

  • Knowledge about drinking limits

    6, 12, 18, 24 months

  • Self-efficacy scores

    6 months

  • Decisional balance scores

    6 months

  • +2 more secondary outcomes

Study Arms (3)

Personal counseling

EXPERIMENTAL
Behavioral: Personal Counseling

Computer generated feedback letters

EXPERIMENTAL
Behavioral: Computer-generated feedback letters

Control group

NO INTERVENTION

Treatment as usual

Interventions

Personal CounselingBEHAVIORAL

At three time-points, participants receive counseling by health professionals trained in Motivational Interviewing based counseling. To assure that both interventions do not differ in their content, individual manuals generated by a software program are used. Counseling will be face-to-face during the hospital stay, and by phone one and three months later.

Personal counseling
Computer-generated feedback lettersBEHAVIORAL

At three time points, participants receive feedback letters, tailored to the stages of change according to the TTM, and generated by a computer software program. The first letter is handed out during their hospital stay and includes normative feedback. One and three months later, participants receive ipsative feedback letters by mail.

Computer generated feedback letters

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Social Medicine and Prevention, University Medicine Greifswald

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

Related Publications (5)

  • Krolo-Wicovsky F, Baumann S, Tiede A, Bischof G, John U, Gaertner B, Freyer-Adam J. Do in-person and computer-based brief alcohol interventions reduce tobacco smoking among general hospital patients? Secondary outcomes from a randomized controlled trial. Addict Sci Clin Pract. 2023 Nov 13;18(1):68. doi: 10.1186/s13722-023-00425-7.

    PMID: 37957757DERIVED

  • 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.

    PMID: 35089156DERIVED

  • 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.

    PMID: 31783832DERIVED

  • 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.

    PMID: 28967769DERIVED

  • 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.

    PMID: 28333511DERIVED

Related Links

Study Officials

  • Jennis Freyer-Adam, PhD

    Institute of Social Medicine and Prevention, University Medicine Greifswald

    PRINCIPAL INVESTIGATOR

  • Beate Gaertner, PhD

    Department of Epidemiology and Health Monitoring, Robert Koch-Institute Berlin

    PRINCIPAL INVESTIGATOR

  • Ulrich John, Prof PhD

    Institute of Social Medicine and Prevention, University Medicine Greifswald

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

February 4, 2011

First Posted

February 8, 2011

Study Start

February 1, 2011

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

DE(1)