Testing Alcohol Interventions Among Job-seekers

Hazardous Drinking Clinical Trial

— TOPAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01311245
• Other study ID #: DM5-IESO03
• Secondary ID: FR2661/1-1FR2661
• Status: Completed
• Phase: Phase 2
• First received: March 7, 2011
• Last updated: December 1, 2015
• Start date: July 2008
• Est. completion date: March 2011

Study information

• Verified date: December 2015
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1243
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hazardous Drinking

Intervention

Behavioral:
• Stage-tailored intervention
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 Intervention
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.

Locations

Country	Name	City	State
Germany	Agentur für Arbeit	Greifswald
Germany	Agentur für Arbeit	Stralsund
Germany	Arbeitsgemeinschaft	Stralsund

Sponsors (2)

Lead Sponsor	Collaborator
University Medicine Greifswald	German Research Foundation

Country where clinical trial is conducted

Germany, 

References & Publications (7)

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 — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Motivation to reduce drinking	Assessed by the Readiness to Change Questionnaire	6 and 15 months	No
Secondary	Attempts to reduce drinking		6 and 15 months	No
Secondary	Knowledge about drinking limits		6 and 15 months	No
Secondary	Alcohol related problems		6 and 15 months	No
Secondary	Self-rated health		6 and months	No

External Links

•   German Research Foundation
•   Homepage Institute of Social Medicine and Prevention, University Medicine Greifswald