Alcohol DrinkingNCT01668771
Self-Affirmation and Response to Health Risk Information
An observational study of Alcohol Drinking and Emotions, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Self-affirmation is the process of reflecting on values that a person considers important. This process may encourage people to be more open to information about health risks. It may also encourage them to change their behaviors or lifestyle to decrease these health risks. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Alcohol Drinking, Emotions, Ego
- How many people
- 1,116 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2012to 13 May 2013
- Phase
- Observational
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knowledge Networks panel respondents will be included if they are women who report having consumed the equivalent of 2-3 or more alcoholic beverage per week and/ or 3 or more alcoholic beverages in one sitting.
- Women will be included if they report drinking 3 or more drinks on any occasion, or more than 2-3 times per week.
Who cannot join
- Women will be excluded if they report never drinking alcohol or drinking monthly or 2-4 times per month, 1-2 drinks or less each time.
- All men, and women who report a lower threshold of alcohol consumption, will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Self-Affirmation, Affect, and Implementation Intentions for Alcohol Cessation
Background:
- Self-affirmation is the process of reflecting on values that a person considers important. This process may encourage people to be more open to information about health risks. It may also encourage them to change their behaviors or lifestyle to decrease these health risks. Researchers want to look at the effect of self-affirmation on people s responses to new health risk information. Because recent studies have linked alcohol consumption to increased risk of breast cancer, the study will focus on alcohol s link to breast cancer.
Read more
Objectives:
- To study how self-affirmation can change opinions following a message about a health risk.
Eligibility:
- Women at least 18 years of age who drink at least two alcoholic beverages per week and/or at least three alcoholic beverages per sitting.
Design:
- Participants will be recruited through an online panel. The study will be conducted entirely online.
- Participants will respond to two short studies. The first will ask about life events and how they make people feel. The second will look at how people respond to information about alcohol and breast cancer.
- For the first study, participants will write a paragraph or two about an important event in their lives. They will answer questions about how that event made them feel. They will also write a paragraph about an important personal value.
- For the second study, participants will read information about alcohol and breast cancer risk. They will then answer questions about this information. They will also answer questions about their beliefs about alcohol and breast cancer.
- Participants will receive financial compensation for being in this study.
Read the detailed description
This study aims to examine whether emotional state moderates the effect of self-affirmation on intentions to engage in proactive behavior following a message about a health threat. Specifically, we propose to examine whether self-affirmation a process by which individuals reflect on cherished personal values differentially affects the persuasiveness of a message about the link between alcohol and breast cancer depending on whether individuals are in a particular emotional state. Previous evidence suggests that self affirmation may reduce defensiveness to threatening health information, increasing openness to the message and resulting in increased disease risk perceptions, disease-related worry, and intentions to engage in preventive behavior. However, self-affirmation may be differentially effective depending on the prior emotional state of the individual. Human subjects (women who report having consumed one or more alcoholic beverages in the past month) will be randomly assigned to write about an emotional event (something that made them happy, sad, angry, or hopeful) or to a neutral emotion condition (writing about a room in their house). Then, they will be randomly assigned to self-affirm (write about why a particular value is important to them) or to be in a control condition (write about why a particular value might be important to someone else). Following the autobiographical emotion task and self-affirmation, subjects will read about the link between alcohol and breast cancer. Finally, they will be asked a series of questions about their intentions to reduce drinking, their perceived risk of breast cancer, and their worry about breast cancer. Drawing on previous research, we hypothesize that self-affirmation will be most effective for those asked to recall a happy or angry experience, and least effective for those asked to recall a sad or hopeful experience
- Conditions
- Alcohol Drinking, Emotions, Ego
- Keywords
- Self-Affirmation, Affect, Alcohol
- Medical subject headings
- Alcohol Drinking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study start11 Aug 2012
- Study completion13 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,116 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Rebecca A Ferrer, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668771
- Sponsor's protocol ID
- 999912162
- Other IDs
- 12-C-N162
- Status last verified
- 13 May 2013
- First submitted
- 16 Aug 2012
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Armitage CJ, Harris PR, Hepton G, Napper L. Self-affirmation increases acceptance of health-risk information among UK adult smokers with low socioeconomic status. Psychol Addict Behav. 2008 Mar;22(1):88-95. doi: 10.1037/0893-164X.22.1.88.
PubMed 18298234Cavanaugh LA, Cutright KM, Luce MF, Bettman JR. Hope, pride, and processing during optimal and nonoptimal times of day. Emotion. 2011 Feb;11(1):38-46. doi: 10.1037/a0022016.
PubMed 21401223Crocker J, Niiya Y, Mischkowski D. Why does writing about important values reduce defensiveness? Self-affirmation and the role of positive other-directed feelings. Psychol Sci. 2008 Jul;19(7):740-7. doi: 10.1111/j.1467-9280.2008.02150.x.
PubMed 18727791
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Affirmation, Affect, and Implementation Intentions for Alcohol Cessation
- ClinicalTrials.gov ID
- NCT01668771
- Acronym / sponsor ID
- 999912162
- Conditions
- Alcohol Drinking, Emotions, Ego
- Keywords
- Self-Affirmation, Affect, Alcohol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,116 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 11 Aug 2012
- Study completion
- 13 May 2013
- First posted
- 20 Aug 2012 (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.
Background:
- Self-affirmation is the process of reflecting on values that a person considers important. This process may encourage people to be more open to information about health risks. It may also encourage them to change their behaviors or lifestyle to decrease these health risks. Researchers want to look at the effect of self-affirmation on people s responses to new health risk information. Because recent studies have linked alcohol consumption to increased risk of breast cancer, the study will focus on alcohol s link to breast cancer.
Objectives:
- To study how self-affirmation can change opinions following a message about a health risk.
Eligibility:
- Women at least 18 years of age who drink at least two alcoholic beverages per week and/or at least three alcoholic beverages per sitting.
Design:
- Participants will be recruited through an online panel. The study will be conducted entirely online.
- Participants will respond to two short studies. The first will ask about life events and how they make people feel. The second will look at how people respond to information about alcohol and breast cancer.
- For the first study, participants will write a paragraph or two about an important event in their lives. They will answer questions about how that event made them feel. They will also write a paragraph about an important personal value.
- For the second study, participants will read information about alcohol and breast cancer risk. They will then answer questions about this information. They will also answer questions about their beliefs about alcohol and breast cancer.
- Participants will receive financial compensation for being in this study.
Detailed description
This study aims to examine whether emotional state moderates the effect of self-affirmation on intentions to engage in proactive behavior following a message about a health threat. Specifically, we propose to examine whether self-affirmation a process by which individuals reflect on cherished personal values differentially affects the persuasiveness of a message about the link between alcohol and breast cancer depending on whether individuals are in a particular emotional state. Previous evidence suggests that self affirmation may reduce defensiveness to threatening health information, increasing openness to the message and resulting in increased disease risk perceptions, disease-related worry, and intentions to engage in preventive behavior. However, self-affirmation may be differentially effective depending on the prior emotional state of the individual. Human subjects (women who report having consumed one or more alcoholic beverages in the past month) will be randomly assigned to write about an emotional event (something that made them happy, sad, angry, or hopeful) or to a neutral emotion condition (writing about a room in their house). Then, they will be randomly assigned to self-affirm (write about why a particular value is important to them) or to be in a control condition (write about why a particular value might be important to someone else). Following the autobiographical emotion task and self-affirmation, subjects will read about the link between alcohol and breast cancer. Finally, they will be asked a series of questions about their intentions to reduce drinking, their perceived risk of breast cancer, and their worry about breast cancer. Drawing on previous research, we hypothesize that self-affirmation will be most effective for those asked to recall a happy or angry experience, and least effective for those asked to recall a sad or hopeful experience
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Knowledge Networks panel respondents will be included if they are women who report having consumed the equivalent of 2-3 or more alcoholic beverage per week and/ or 3 or more alcoholic beverages in one sitting.
- Women will be included if they report drinking 3 or more drinks on any occasion, or more than 2-3 times per week.
Key exclusion criteria (2 listed)
- Women will be excluded if they report never drinking alcohol or drinking monthly or 2-4 times per month, 1-2 drinks or less each time.
- All men, and women who report a lower threshold of alcohol consumption, will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 5 Apr 2018.
- Background: PubMed 18298234Armitage CJ, Harris PR, Hepton G, Napper L. Self-affirmation increases acceptance of health-risk information among UK adult smokers with low socioeconomic status. Psychol Addict Behav. 2008 Mar;22(1):88-95. doi: 10.1037/0893-164X.22.1.88.
- Background: PubMed 21401223Cavanaugh LA, Cutright KM, Luce MF, Bettman JR. Hope, pride, and processing during optimal and nonoptimal times of day. Emotion. 2011 Feb;11(1):38-46. doi: 10.1037/a0022016.
- Background: PubMed 18727791Crocker J, Niiya Y, Mischkowski D. Why does writing about important values reduce defensiveness? Self-affirmation and the role of positive other-directed feelings. Psychol Sci. 2008 Jul;19(7):740-7. doi: 10.1111/j.1467-9280.2008.02150.x.
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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.
Rebecca A Ferrer, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Drinking and Emotions, run by National Cancer Institute (NCI) 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 2 inclusion and 2 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 5 Apr 2018. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01668771, which also lists 3 linked publications.
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 5 Apr 2018.