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Hazardous DrinkingPhase 2/3PECONCT01291693

Testing Delivery Channels of Brief Motivational Alcohol Intervention

A Phase 2/3 study testing Personal Counseling and Computer-generated feedback letters in people with Hazardous Drinking, run by University Medicine Greifswald at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Hazardous Drinking
What is being tested?
Personal Counseling and Computer-generated feedback letters
Could I receive a placebo?
No, everyone receives an active treatment
How many people
975 participants
Where
1 siteGermany
Study dates
Feb 2011to Nov 2014
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Institute of Social Medicine and Prevention, University Medicine Greifswald

    Greifswald, Mecklenburg-Vorpommern, 17475

Other trials in Germany

About this study

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

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.

Being tested
Personal Counseling, Computer-generated feedback letters
Keywords
Hazardous drinking, general hospital, brief intervention, Motivational Interviewing, computer-generated feedback, stage-tailored, delivery channel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personal CounselingBehavioural

    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 lettersBehavioural

    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.

Study groups in NCT01291693
Study groupRoleWhat they receive
Personal counselingExperimentalNot described
Receives: Behavioral: Personal Counseling
Computer generated feedback lettersExperimentalNot described
Receives: Behavioral: Computer-generated feedback letters
Control groupNo interventionTreatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6, 12, 18, 24 months

Secondary outcomes (7)

  1. Motivation to reduce drinking

    Assessed by a stages of change-algorithm

    Measured: 6, 12, 18, 24 months

  2. Attempts to reduce drinking

    Measured: 6, 12, 18, 24 months

  3. Knowledge about drinking limits

    Measured: 6, 12, 18, 24 months

  4. Self-efficacy scores

    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.

    Measured: 6 months

  5. Decisional balance scores

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

    Measured: 6 months

  6. Self-rated health

    Measured: 6, 12, 18, 24 months

  7. Health care utilization

    Measured: 6, 12, 18, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
975 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01291693
Sponsor's protocol ID
108376
Other IDs
DM8-IESO03, 108376, DM8-IESO04, 109737, 110676, 110543, 111346
Acronym
PECO
Status last verified
Dec 2015
First submitted
4 Feb 2011
Last updated
3 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 37957757

  • 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.

    PubMed 35089156

  • 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.

    PubMed 31783832

  • 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.

    PubMed 28967769

  • 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.

    PubMed 28333511

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Personal Counseling and Computer-generated feedback letters in people with Hazardous Drinking, run by University Medicine Greifswald at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Risky drinking (time frame: 6, 12, 18, 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01291693, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015; AzTrials last refreshed its copy on 7 Nov 2026.

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