Testing Delivery Channels of Brief Motivational Alcohol Intervention

NCT ID: NCT01291693

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

975 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hazardous Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Personal counseling

Group Type EXPERIMENTAL

Personal Counseling

Intervention Type BEHAVIORAL

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.

Computer generated feedback letters

Group Type EXPERIMENTAL

Computer-generated feedback letters

Intervention Type BEHAVIORAL

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.

Control group

Treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Personal Counseling

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.

Intervention Type BEHAVIORAL

Computer-generated feedback letters

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Cancer Aid

OTHER

Sponsor Role collaborator

University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

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Dr. Jennis Freyer-Adam

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennis Freyer-Adam, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Social Medicine and Prevention, University Medicine Greifswald

Beate Gaertner, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Ulrich John, Prof PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Social Medicine and Prevention, University Medicine Greifswald

Locations

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Institute of Social Medicine and Prevention, University Medicine Greifswald

Greifswald, Mecklenburg-Vorpommern, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 37957757 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35089156 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31783832 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28967769 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28333511 (View on PubMed)

Related Links

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http://www2.medizin.uni-greifswald.de/prevention/1/

Homepage Institute of Social Medicine and Prevention, University Medicine Greifswald

Other Identifiers

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DM8-IESO03

Identifier Type: REGISTRY

Identifier Source: secondary_id

108376

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

DM8-IESO04

Identifier Type: REGISTRY

Identifier Source: secondary_id

109737

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

110676

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

110543

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

111346

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

108376

Identifier Type: -

Identifier Source: org_study_id