Testing Alcohol Interventions Among Job-seekers (TOPAS)

December 1, 2015 updated by: Dr. Jennis Freyer-Adam, University Medicine Greifswald

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1243

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Greifswald, Germany, 17489
        • Agentur für Arbeit
      • Stralsund, Germany, 18437
        • Agentur für Arbeit
      • Stralsund, Germany, 18437
        • Arbeitsgemeinschaft

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risky drinking
Time Frame: 6 and 15 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motivation to reduce drinking
Time Frame: 6 and 15 months
Assessed by the Readiness to Change Questionnaire
6 and 15 months
Attempts to reduce drinking
Time Frame: 6 and 15 months
6 and 15 months
Knowledge about drinking limits
Time Frame: 6 and 15 months
6 and 15 months
Alcohol related problems
Time Frame: 6 and 15 months
6 and 15 months
Self-rated health
Time Frame: 6 and months
6 and months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medicine Greifswald

Collaborators

German Research Foundation

Investigators

  • Principal Investigator: Jennis Freyer-Adam, PhD, Institute of Social Medicine and Prevention, University Medicine Greifswald

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

March 7, 2011

First Submitted That Met QC Criteria

March 8, 2011

First Posted (Estimate)

March 9, 2011

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DM5-IESO03
  • FR2661/1-1 (Other Grant/Funding Number: German Research Foundation)
  • FR2661/1-2 (Other Grant/Funding Number: German Research Foundation)
  • DM5-IESO05 (Registry Identifier: University Medicine Greifswald)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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