Alcohol DrinkingPhase 3PSC3NCT00732095
Promoting Self-Change From Alcohol Problems: Mechanisms of Change in a Community-Based Intervention
A Phase 3 study testing Promoting Self-Change with Ads in people with Alcohol Drinking and Alcohol Abuse, run by Nova Southeastern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Alcohol Abuse
- What is being tested?
- Promoting Self-Change with Ads
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Aug 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 21 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nova Southeastern University, Center for Psychological Studies
Fort Lauderdale, Florida, 33314
About this study
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.
Read the detailed description
Brief Overview: 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 time points (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.
Main Goals and Justification The proposed research project is an outgrowth and extension of research Drs. Linda and Mark Sobell have been conducting for many years. That research began with investigations of individuals who recovered from alcohol problems without treatment (natural recoveries). A major finding of the natural recovery research, conducted in Canada but now supported by similar data from the US, was that rather than an uncommon occurrence, self-change is the major pathway to change. Another finding of our natural recovery research was that the most commonly reported precipitant of change was a cognitive appraisal (i.e., cost-benefit analysis) 1that occurred over time rather than some particular isolated event (event-precipitated recovery). The individuals most likely to achieve a natural recovery are those who do not have severe problems and who also tend not to access treatment resources.
Our natural recovery research findings led to the design of a study, Promoting Self-Change, intended to encourage problem drinkers within a community setting who have never sought treatment or formal help to change their drinking their own (Sobell et al., 1996). The experimental intervention in the PSC study was modeled on the evidence-based materials developed for use in the Guided Self-Change model of treatment, a brief cognitive-behavioral motivational intervention Although both the experimental and control groups showed significant reduction in their drinking from 1-year pre- to 1-year post-intervention, the results showed that people who received the experimental motivational materials showed no greater change than those who received the two alcohol pamphlets that were freely available in the community (Sobell et al., 2002).
Fortunately, because we had collected drinking data using the Timeline Followback (Sobell \& Sobell, 1992, 2003, 2007 in press) and kept records of important events (e.g., date person called to be screened, date assessment materials mailed), it allowed us to explore when change occurred. Contrary to the our hypothesis, the major reduction in drinking does not appear to have occurred after the intervention materials were received, but rather after participants saw the study advertisements. Thus, as will be discussed in detail in the design section, seeing the ads and the message in the ads was identified as possible important precipitants of change. The proposed project is a randomized controlled study to investigate these issues.
Based on our previous Promoting Self-Change study, we will conduct a randomized controlled trial consisting of three groups and designed to tease apart alternative possible explanations of mechanisms of behavior change within a community based mail intervention. In particular, the study will investigate the timing of points of inflection (i.e., change) in participants' reported drinking as they participate in the study. The three experimental 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 (when consenting to the study and before the assessment vs. with the intervention material). This design allows the following 5 objectives to be addressed:
- To evaluate if a message that communicates that self-change (i.e., alcohol problem) is common will prompt participants to engage in a process of self-change resulting in changes in their drinking behavior
- To evaluate whether there is a difference in effectiveness depending on when the message that self-change is common is presented (before the assessment versus at the intervention)
- To evaluate whether only seeing an advertisement prompts participants to think about changing their drinking and then change on their own in the absences of a message that self-change is common
- To evaluate whether receiving the message as part of the intervention materials adds value over the effect of receiving only the intervention materials.
- To conduct correlative investigations of whether participants report changes in their drinking contiguous with first seeing the advertisement, receiving the assessment materials (without the message), and receiving the intervention feedback.
Possible explanations for how the message could function as a mechanism of behavior change are offered from catastrophe theory and cognitive social learning theory. The ultimate objective of this line of research is the development of cost-effective, large scale interventions that can serve as an early stage in a public health, stepped care model by encouraging self-change in the community for individuals with alcohol problems.
- Conditions
- Alcohol Drinking, Alcohol Abuse
- Being tested
- Promoting Self-Change with Ads
- Keywords
- Self-change, Natural recovery, Alcohol Drinking, Mechanisms of Change, Advertisements
- Medical subject headings
- Alcohol Drinking, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promoting Self-Change with AdsBehavioural
Use of Ads immediate or delayed or no ad
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Immediate Ad Receives: Behavioral: Promoting Self-Change with Ads |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduced alcohol use
Measured: 3 months post intervention
Secondary outcomes (1)
reduced alcohol related consequences
Measured: 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startMar 2008
- Primary completionMay 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Investigators
- Linda C Sobell, Ph.D., Principal investigator, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732095
- Sponsor's protocol ID
- 1R21AA017136
- Other IDs
- 1R21AA017136
- Acronym
- PSC3
- Status last verified
- Dec 2010
- First submitted
- 7 Aug 2008
- Last updated
- 14 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12068264
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Self-Change From Alcohol Problems: Mechanisms of Change in a Community-Based Intervention
- ClinicalTrials.gov ID
- NCT00732095
- Acronym / sponsor ID
- PSC3 / 1R21AA017136
- Conditions
- Alcohol Drinking, Alcohol Abuse
- Keywords
- Self-change, Natural recovery, Alcohol Drinking, Mechanisms of Change, Advertisements
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 11 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Brief Overview: 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 time points (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.
Main Goals and Justification The proposed research project is an outgrowth and extension of research Drs. Linda and Mark Sobell have been conducting for many years. That research began with investigations of individuals who recovered from alcohol problems without treatment (natural recoveries). A major finding of the natural recovery research, conducted in Canada but now supported by similar data from the US, was that rather than an uncommon occurrence, self-change is the major pathway to change. Another finding of our natural recovery research was that the most commonly reported precipitant of change was a cognitive appraisal (i.e., cost-benefit analysis) 1that occurred over time rather than some particular isolated event (event-precipitated recovery). The individuals most likely to achieve a natural recovery are those who do not have severe problems and who also tend not to access treatment resources.
Our natural recovery research findings led to the design of a study, Promoting Self-Change, intended to encourage problem drinkers within a community setting who have never sought treatment or formal help to change their drinking their own (Sobell et al., 1996). The experimental intervention in the PSC study was modeled on the evidence-based materials developed for use in the Guided Self-Change model of treatment, a brief cognitive-behavioral motivational intervention Although both the experimental and control groups showed significant reduction in their drinking from 1-year pre- to 1-year post-intervention, the results showed that people who received the experimental motivational materials showed no greater change than those who received the two alcohol pamphlets that were freely available in the community (Sobell et al., 2002).
Fortunately, because we had collected drinking data using the Timeline Followback (Sobell \& Sobell, 1992, 2003, 2007 in press) and kept records of important events (e.g., date person called to be screened, date assessment materials mailed), it allowed us to explore when change occurred. Contrary to the our hypothesis, the major reduction in drinking does not appear to have occurred after the intervention materials were received, but rather after participants saw the study advertisements. Thus, as will be discussed in detail in the design section, seeing the ads and the message in the ads was identified as possible important precipitants of change. The proposed project is a randomized controlled study to investigate these issues.
Based on our previous Promoting Self-Change study, we will conduct a randomized controlled trial consisting of three groups and designed to tease apart alternative possible explanations of mechanisms of behavior change within a community based mail intervention. In particular, the study will investigate the timing of points of inflection (i.e., change) in participants' reported drinking as they participate in the study. The three experimental 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 (when consenting to the study and before the assessment vs. with the intervention material). This design allows the following 5 objectives to be addressed:
- To evaluate if a message that communicates that self-change (i.e., alcohol problem) is common will prompt participants to engage in a process of self-change resulting in changes in their drinking behavior
- To evaluate whether there is a difference in effectiveness depending on when the message that self-change is common is presented (before the assessment versus at the intervention)
- To evaluate whether only seeing an advertisement prompts participants to think about changing their drinking and then change on their own in the absences of a message that self-change is common
- To evaluate whether receiving the message as part of the intervention materials adds value over the effect of receiving only the intervention materials.
- To conduct correlative investigations of whether participants report changes in their drinking contiguous with first seeing the advertisement, receiving the assessment materials (without the message), and receiving the intervention feedback.
Possible explanations for how the message could function as a mechanism of behavior change are offered from catastrophe theory and cognitive social learning theory. The ultimate objective of this line of research is the development of cost-effective, large scale interventions that can serve as an early stage in a public health, stepped care model by encouraging self-change in the community for individuals with alcohol problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Promoting Self-Change with AdsImmediate Ad |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 21 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Promoting Self-Change with AdsUse of Ads immediate or delayed or no ad | Behavioural | Experimental |
Primary outcome
reduced alcohol use
Time frame: 3 months post intervention
1 secondary outcome
reduced alcohol related consequences
Time frame: 3 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2010.
- Background: PubMed 12068264Sobell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda C Sobell, Ph.D. principal investigator
Nova Southeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Promoting Self-Change with Ads in people with Alcohol Drinking and Alcohol Abuse, run by Nova Southeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduced alcohol use (time frame: 3 months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00732095, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2010.