Testing Alcohol Interventions Among Job-seekers (TOPAS)

This study has been completed.
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Dr. Jennis Freyer-Adam, University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT01311245
First received: March 7, 2011
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Hazardous Drinking
Behavioral: Stage-tailored intervention
Behavioral: Non-stage-tailored Intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Testing Stage Tailored vs. Non-stage Tailored Interventions Among Job-seekers With Risky Drinking

Further study details as provided by University Medicine Greifswald:

Primary Outcome Measures:
  • Risky drinking [ Time Frame: 6 and 15 months ] [ Designated as safety issue: No ]
    Determined by using average alcohol consumption per day, heavy occasional drinking, the Alcohol Use Disorder Identification Test-Consumtion (AUDIT-C) score


Secondary Outcome Measures:
  • Motivation to reduce drinking [ Time Frame: 6 and 15 months ] [ Designated as safety issue: No ]
    Assessed by the Readiness to Change Questionnaire

  • Attempts to reduce drinking [ Time Frame: 6 and 15 months ] [ Designated as safety issue: No ]
  • Knowledge about drinking limits [ Time Frame: 6 and 15 months ] [ Designated as safety issue: No ]
  • Alcohol related problems [ Time Frame: 6 and 15 months ] [ Designated as safety issue: No ]
  • Self-rated health [ Time Frame: 6 and months ] [ Designated as safety issue: No ]

Enrollment: 1243
Study Start Date: July 2008
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stage-tailored
At baseline and three months later
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.
Experimental: Non-stage-tailored
At baseline and three months later
Behavioral: 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.
No Intervention: Control group
Assessment only

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01311245

Locations
Germany
Agentur für Arbeit
Greifswald, Germany, 17489
Agentur für Arbeit
Stralsund, Germany, 18437
Arbeitsgemeinschaft
Stralsund, Germany, 18437
Sponsors and Collaborators
University Medicine Greifswald
German Research Foundation
Investigators
Principal Investigator: Jennis Freyer-Adam, PhD Institute of Epidemiology and Social Medicine, University Medicine Greifswald
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Jennis Freyer-Adam, Principle Investigator, University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT01311245     History of Changes
Other Study ID Numbers: DM5-IESO03, FR2661/1-1, FR2661/1-2, DM5-IESO05
Study First Received: March 7, 2011
Last Updated: July 24, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University Medicine Greifswald:
Risky drinking
Brief intervention
Computer-generated feedback
Stage-tailored
Non-stage-tailored

ClinicalTrials.gov processed this record on October 22, 2014