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Hazardous DrinkingPhase 2TOPASNCT01311245

Testing Alcohol Interventions Among Job-seekers

A Phase 2 study testing Stage-tailored intervention and Non-stage-tailored Intervention in people with Hazardous Drinking, run by University Medicine Greifswald at 3 sites 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 the randomized controlled trial was to test two behavioral interventions among job-seekers with risky drinking. The interventions differed in their theoretical background: Intervention A was tailored to the stage of change, and Intervention B was non-stage-tailored. 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?
Stage-tailored intervention and Non-stage-tailored Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,243 participants
Where
3 sitesGermany
Study dates
Jul 2008to Mar 2011
Phase
Phase 2
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

  • Job-seekers with risky drinking (AUDIT-C ≥ 4/5 [women/men] and AUDIT < 20)

Who cannot join

  • Job-seekers already asked to participate during an earlier visit at the job agency
  • Job-seekers not intending to talk to a job-agent/ without waiting time
  • Job-seekers physically or mentally not capable of participating in the study
  • Job-seekers with insufficient language/ reading skills
  • Job-seekers with more severe alcohol problems (AUDIT ≥ 20)
  • Job-seekers employed at the department conducting the study

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • Agentur für Arbeit

    Greifswald, 17489

  • Agentur für Arbeit

    Stralsund, 18437

  • Arbeitsgemeinschaft

    Stralsund, 18437

Other trials in Germany

About this study

Official title: Testing Stage Tailored vs. Non-stage Tailored Interventions Among Job-seekers With Risky Drinking

The aim of the randomized controlled trial was to test two behavioral interventions among job-seekers with risky drinking. The interventions differed in their theoretical background: Intervention A was tailored to the stage of change, and Intervention B was non-stage-tailored. Over 12 months, job-seekers were pro-actively screened for risky drinking at three job-agencies. Job-seekers with risky drinking were asked to participate in the study. All three groups were assessed at baseline, and 3, 6 and 15 months later. The baseline assessment was self-administered using handheld computers. The follow-up assessments by interviews on the phone, primarily. Both intervention groups received individualized computer generated feedback letters at baseline and 3 months later.

Being tested
Stage-tailored intervention, Non-stage-tailored Intervention
Keywords
Risky drinking, Brief intervention, Computer-generated feedback, Stage-tailored, Non-stage-tailored

What participants receive

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

  • Stage-tailored interventionBehavioural

    Based on the Trans-Theoretical Model of intentional behavior change (TTM). According to their stage of change, participants received two computer generated feedback letters on their risky drinking, stage of change, processes of change, self-efficacy, and decisional balance. The first letter included normative feedback (interpersonal comparison with other individuals in the same stage), and was sent out by mail after baseline. The second letter included normative and ipsative feedback (intrapersonal comparisons: baseline vs. 3 months later), and was sent out by mail three months later.

  • Non-stage-tailored InterventionBehavioural

    Based on the Theory of Planned Behavior (TPB). Participants received two computer generated feedback letters on their risky drinking, beliefs (behavioral, normative, control), attitude, subjective norm, perceived behavioral control, intention, and they were asked to fill in a where-when-how to change plan. The first letter included normative feedback (interpersonal comparison with other women/ men), and was sent out by mail after baseline. The second letter included normative and ipsative feedback, and was sent out by mail three months later.

Study groups in NCT01311245
Study groupRoleWhat they receive
Stage-tailoredExperimentalAt baseline and three months later
Receives: Behavioral: Stage-tailored intervention
Non-stage-tailoredExperimentalAt baseline and three months later
Receives: Behavioral: Non-stage-tailored Intervention
Control groupNo interventionAssessment only

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, the Alcohol Use Disorder Identification Test-Consumtion (AUDIT-C) score

    Measured: 6 and 15 months

Secondary outcomes (5)

  1. Motivation to reduce drinking

    Assessed by the Readiness to Change Questionnaire

    Measured: 6 and 15 months

  2. Attempts to reduce drinking

    Measured: 6 and 15 months

  3. Knowledge about drinking limits

    Measured: 6 and 15 months

  4. Alcohol related problems

    Measured: 6 and 15 months

  5. Self-rated health

    Measured: 6 and months

Timeline

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

  1. First posted9 Mar 2011 (estimated)
  2. Study startJul 2008
  3. Primary completionDec 2010
  4. Study completionMar 2011

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
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,243 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01311245
Sponsor's protocol ID
DM5-IESO03
Other IDs
FR2661/1-1, FR2661/1-2, DM5-IESO05
Acronym
TOPAS
Status last verified
Dec 2015
First submitted
7 Mar 2011
Last updated
3 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • Freyer-Adam J, Gaertner B, Tobschall S, John U. Health risk factors and self-rated health among job-seekers. BMC Public Health. 2011 Aug 19;11:659. doi: 10.1186/1471-2458-11-659.

    PubMed 21854611

  • Baumann S, Gaertner B, Schnuerer I, Bischof G, John U, Freyer-Adam J. How well do TTM measures work among a sample of individuals with unhealthy alcohol use that is characterized by low readiness to change? Psychol Addict Behav. 2013 Sep;27(3):573-83. doi: 10.1037/a0029368. Epub 2012 Aug 6.

    PubMed 22867296

  • Freyer-Adam J, Baumann S, Schnuerer I, Haberecht K, Bischof G, John U, Gaertner B. Does stage tailoring matter in brief alcohol interventions for job-seekers? A randomized controlled trial. Addiction. 2014 Nov;109(11):1845-56. doi: 10.1111/add.12677. Epub 2014 Aug 1.

    PubMed 24981701

  • Haberecht K, Schnuerer I, Gaertner B, John U, Freyer-Adam J. The Stability of Social Desirability: A Latent Change Analysis. J Pers. 2015 Aug;83(4):404-12. doi: 10.1111/jopy.12112. Epub 2014 Aug 19.

    PubMed 25041464

  • Baumann S, Gaertner B, Schnuerer I, Haberecht K, John U, Freyer-Adam J. The impact of a stage tailored intervention on alcohol use trajectories among those who do not intend to change. Drug Alcohol Depend. 2015 Feb 1;147:167-74. doi: 10.1016/j.drugalcdep.2014.11.020. Epub 2014 Dec 3.

    PubMed 25500129

  • Schnuerer I, Baumann S, Haberecht K, Gaertner B, John U, Freyer-Adam J. Patterns of health risk behaviors among job-seekers: a latent class analysis. Int J Public Health. 2015 Jan;60(1):111-9. doi: 10.1007/s00038-014-0623-1. Epub 2014 Dec 23.

    PubMed 25532553

  • Baumann S, Gaertner B, Schnuerer I, Haberecht K, John U, Freyer-Adam J. Belief incongruence and the intention-behavior gap in persons with at-risk alcohol use. Addict Behav. 2015 Sep;48:5-11. doi: 10.1016/j.addbeh.2015.04.007. Epub 2015 Apr 18.

    PubMed 25930010

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Stage-tailored intervention and Non-stage-tailored Intervention in people with Hazardous Drinking, run by University Medicine Greifswald at 3 sites 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 3 sites 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 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.

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 and 15 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 NCT01311245, which also lists 7 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.

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