NCT00732095

Brief Summary

Research has found that natural recovery (self-change) is a very common pathway to change for individuals with alcohol problems, accounting for nearly 75% of recoveries in several national surveys. Although few members of the public are aware that self-change is possible, it also is the case that many individuals with alcohol problems do not enter treatment because of the stigma or fear of being labeled. The proposed study is based on findings from a recent randomized controlled trial designed to promote self-change in the community for problem drinkers who had never been in treatment. Media advertisements were used to recruit 825 participants. Eligible respondents were sent assessment materials to complete. After the assessment materials were returned, participants were randomly assigned to receive two alcohol pamphlets that were freely available in the community or personalized feedback based on their assessment responses (e.g., how their drinking compared to national norms, health risks associated with their drinking). A 1-year follow up found that while there were no differences in drinking behavior between the groups, both groups had very substantial reductions in their drinking 1-year pre- to 1-year post-intervention. In an attempt to determine what accounted for the change, participants' reports of their drinking were evaluated with regard to critical study elements (e. g., when assessment materials were received). Surprisingly, results revealed that many changed after seeing the advertisement, and before receiving the assessment materials to complete. This suggests that either seeing the ad ("Thinking about changing your drinking?") or a message in the ad ("Did you know that 75% of people change their drinking on their own?") may have catalyzed the change. To evaluate when change occurs and the mechanisms that may give rise to change, a randomized controlled trial involving 3 groups will be conducted. The groups will differ in whether they receive a message informing them that self-change is a common phenomenon (two groups will receive the message, one will not) and the occasion when the message is delivered (consenting to the study and before the assessment vs. with the intervention material). Comparisons made possible by the experimental design will allow an evaluation of the message as a precipitant of change. The use of Timeline Followback retrospective reports of daily drinking and recording of critical dates will allow statistical analysis of patterns of inflection (i.e., change in drinking) related to seeing the ad, receiving the message, receiving and completing the assessment materials, and receiving the intervention materials. Possible explanations for how the message could function as a mechanism of behavior change are offered (e.g., catastrophe theory, cognitive social learning theory). The ultimate objective of this research is to develop cost-effective, large scale interventions that can be viewed as an early stage in a public health, stepped care model by encouraging self-change for individuals with alcohol problems.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
283

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

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

March 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

December 14, 2010

Status Verified

December 1, 2010

Enrollment Period

2.2 years

First QC Date

August 7, 2008

Last Update Submit

December 13, 2010

Conditions

Keywords

Self-changeNatural recoveryAlcohol DrinkingMechanisms of ChangeAdvertisements

Outcome Measures

Primary Outcomes (1)

  • reduced alcohol use

    3 months post intervention

Secondary Outcomes (1)

  • reduced alcohol related consequences

    3 months post intervention

Study Arms (1)

Experimental

EXPERIMENTAL

Immediate Ad

Behavioral: Promoting Self-Change with Ads

Interventions

Use of Ads immediate or delayed or no ad

Experimental

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older (legal drinking age in US)
  • report drinking an average of \>12 drinks per week or having consumed ≥ 5 drinks on ≥ 5 days in the past year
  • sign an informed consent
  • willing to participate in a 90-day follow-up interview by mail after the intervention
  • willing to provide the name, address and phone number of a relative or friend who has known the participant and is willing to be provide information in the form of a short questionnaire about the participant's alcohol use and functioning 90 days after the intervention starts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Southeastern University, Center for Psychological Studies

Fort Lauderdale, Florida, 33314, United States

Location

Related Publications (1)

  • Sobell LC, Sobell MB, Leo GI, Agrawal S, Johnson-Young L, Cunningham JA. Promoting self-change with alcohol abusers: a community-level mail intervention based on natural recovery studies. Alcohol Clin Exp Res. 2002 Jun;26(6):936-48.

    PMID: 12068264BACKGROUND

MeSH Terms

Conditions

Alcohol DrinkingAlcoholism

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Linda C Sobell, Ph.D.

    Nova Southeastern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 7, 2008

First Posted

August 11, 2008

Study Start

March 1, 2008

Primary Completion

May 1, 2010

Study Completion

August 1, 2010

Last Updated

December 14, 2010

Record last verified: 2010-12

Locations