NCT01311245

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,243

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

3 active sites

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

July 1, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2011

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

2.4 years

First QC Date

March 7, 2011

Last Update Submit

December 1, 2015

Conditions

Hazardous Drinking

Keywords

Risky drinkingBrief interventionComputer-generated feedbackStage-tailoredNon-stage-tailored

Outcome Measures

Primary Outcomes (1)

  • Risky drinking

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

    6 and 15 months

Secondary Outcomes (5)

  • Motivation to reduce drinking

    6 and 15 months

  • Attempts to reduce drinking

    6 and 15 months

  • Knowledge about drinking limits

    6 and 15 months

  • Alcohol related problems

    6 and 15 months

  • Self-rated health

    6 and months

Study Arms (3)

Stage-tailored

EXPERIMENTAL

At baseline and three months later

Behavioral: Stage-tailored intervention

Non-stage-tailored

EXPERIMENTAL

At baseline and three months later

Behavioral: Non-stage-tailored Intervention

Control group

NO INTERVENTION

Assessment only

Interventions

Stage-tailored interventionBEHAVIORAL

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.

Stage-tailored
Non-stage-tailored InterventionBEHAVIORAL

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.

Non-stage-tailored

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Agentur für Arbeit

Greifswald, 17489, Germany

Location

Agentur für Arbeit

Stralsund, 18437, Germany

Location

Arbeitsgemeinschaft

Stralsund, 18437, Germany

Location

Related Publications (7)

  • 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.

    PMID: 21854611RESULT

  • 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.

    PMID: 22867296RESULT

  • 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.

    PMID: 24981701RESULT

  • 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.

    PMID: 25041464RESULT

  • 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.

    PMID: 25500129RESULT

  • 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.

    PMID: 25532553RESULT

  • 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.

    PMID: 25930010RESULT

Related Links

Study Officials

  • Jennis Freyer-Adam, 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
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 7, 2011

First Posted

March 9, 2011

Study Start

July 1, 2008

Primary Completion

December 1, 2010

Study Completion

March 1, 2011

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

DE(3)