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NCT Number: NCT01291693

Testing Delivery Channels of Brief Motivational Alcohol Intervention

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.

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Key information

Conditions

Hazardous Drinking

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Institute of Social Medicine and Prevention, University Medicine Greifswald

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Personal Counseling

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

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.

Primary outcomes

  1. Risky drinking

    Time frame: 6, 12, 18, 24 months

    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

Secondary outcomes

  1. Motivation to reduce drinking

    Time frame: 6, 12, 18, 24 months

    Assessed by a stages of change-algorithm

  2. Attempts to reduce drinking

    Time frame: 6, 12, 18, 24 months

  3. Knowledge about drinking limits

    Time frame: 6, 12, 18, 24 months

  4. Self-efficacy scores

    Time frame: 6 months

    Assessed by a modified short-form of the Alcohol-Abstinence-Self-Efficacy-Scale (AASE). The modified form assesses self-efficacy regarding compliance with drinking limits.

  5. Decisional balance scores

    Time frame: 6 months

    Assessed by a short form of the Alcohol Decisional Balance Scale (ADBS)

  6. Self-rated health

    Time frame: 6, 12, 18, 24 months

  7. Health care utilization

    Time frame: 6, 12, 18, 24 months

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Collaborators

  • German Cancer Aid

Registry information

Official study title

Testing Delivery Channels of Brief Motivational Alcohol Intervention Among General Hospital Inpatients With Risky Drinking: Personal Counseling Versus Computer-generated Feedback Letters

Acronym: PECO

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 8, 2011
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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