Risk Reduction BehaviorNCT02311400
Self-Affirmation, Emotion, and Alcohol Consumption
An observational study of Risk Reduction Behavior, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: People respond differently to life events and how those events make them feel. They also respond differently to information about the how their actions affect their lives and health. Researchers want to learn more about these differences. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Risk Reduction Behavior
- How many people
- 690 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2014to 29 Sep 2016
- 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
- Women who have never been diagnosed with cancer and who drank 5 + alcoholic beverages in the past week will be eligible to participate. All men, and women who report a lower threshold of alcohol consumption, will be excluded.
- Children will be excluded from this study.
- Participants who have completed prior self-affirmation studies through GfK (e.g., the one conducted under 12-C-N162-B) will also be excluded; these participants will be identified by GfK (based on records of study participation kept for panel members), and will not be invited to participate in the current study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Background:
- People respond differently to life events and how those events make them feel. They also respond differently to information about the how their actions affect their lives and health. Researchers want to learn more about these differences. In this study, researchers will look at how people respond to an event in their life. Researchers will also look at how people respond to information about how their actions can affect their health.
Read more
Objective:
- To see how people respond differently to life events and information about alcohol and breast cancer.
Eligibility:
- Women 18 and older who have never been diagnosed with cancer and who drank 5 or more alcoholic drinks in the past week.
Design:
- This study will take place online.
- Participants will be randomly assigned to 1 of 10 groups.
- Researchers will ask participants to take part in 2 small studies, 1 about Life Events and 1 about Alcohol and Breast Cancer.
- In the Life Events study, participants will write briefly about a time they felt very happy, fearful, angry, or surprised, or they will write about a room in their house. Then they will answer questions about that event. They also will write about a value that is or is not important to them.
- In the Alcohol and Breast Cancer study, participants will read a health message about the link between alcohol and breast cancer. Then they will answer questions about what they read and give their thoughts about alcohol and breast cancer.
- Both studies should take about 30 minutes.
Read the detailed description
This study aims to examine whether emotional state moderates the effect of selfaffirmation on intentions to engage in proactive behavior following a message about a health threat. Specifically, we propose to examine whether selfaffirmation 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 five or more alcoholic beverage in the past week) will be randomly assigned to write about an emotional event (something that made them happy, fearful, angry, or surprised) or to a neutral emotion condition (writing about a room in their house). Then, they will be randomly assigned to selfaffirm (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 fearful or surprising experience.
- Conditions
- Risk Reduction Behavior
- Keywords
- Emotion, Self-Affirmation, Alcohol Consumption
- Medical subject headings
- Risk Reduction Behavior, Alcohol Drinking
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol cessation intentions
Measured: immediately post-experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study start19 Nov 2014
- Primary completion1 Apr 2015
- Study completion29 Sep 2016
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 Risk Reduction BehaviorStudies 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
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 690 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Rebecca A Ferrer, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311400
- Sponsor's protocol ID
- 999915030
- Other IDs
- 15-C-N030
- Status last verified
- 29 Sep 2016
- First submitted
- 5 Dec 2014
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Epton T, Harris PR. Self-affirmation promotes health behavior change. Health Psychol. 2008 Nov;27(6):746-52. doi: 10.1037/0278-6133.27.6.746.
PubMed 19025270Lerner JS, Keltner D. Fear, anger, and risk. J Pers Soc Psychol. 2001 Jul;81(1):146-59. doi: 10.1037//0022-3514.81.1.146.
PubMed 11474720Harris PR, Napper L. Self-affirmation and the biased processing of threatening health-risk information. Pers Soc Psychol Bull. 2005 Sep;31(9):1250-63. doi: 10.1177/0146167205274694.
PubMed 16055644
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, Emotion, and Alcohol Consumption
- ClinicalTrials.gov ID
- NCT02311400
- Acronym / sponsor ID
- 999915030
- Conditions
- Risk Reduction Behavior
- Keywords
- Emotion, Self-Affirmation, Alcohol Consumption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 690 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 19 Nov 2014
- Primary completion
- 1 Apr 2015 (actual)
- Study completion
- 29 Sep 2016 (actual)
- First posted
- 8 Dec 2014 (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:
- People respond differently to life events and how those events make them feel. They also respond differently to information about the how their actions affect their lives and health. Researchers want to learn more about these differences. In this study, researchers will look at how people respond to an event in their life. Researchers will also look at how people respond to information about how their actions can affect their health.
Objective:
- To see how people respond differently to life events and information about alcohol and breast cancer.
Eligibility:
- Women 18 and older who have never been diagnosed with cancer and who drank 5 or more alcoholic drinks in the past week.
Design:
- This study will take place online.
- Participants will be randomly assigned to 1 of 10 groups.
- Researchers will ask participants to take part in 2 small studies, 1 about Life Events and 1 about Alcohol and Breast Cancer.
- In the Life Events study, participants will write briefly about a time they felt very happy, fearful, angry, or surprised, or they will write about a room in their house. Then they will answer questions about that event. They also will write about a value that is or is not important to them.
- In the Alcohol and Breast Cancer study, participants will read a health message about the link between alcohol and breast cancer. Then they will answer questions about what they read and give their thoughts about alcohol and breast cancer.
- Both studies should take about 30 minutes.
Detailed description
This study aims to examine whether emotional state moderates the effect of selfaffirmation on intentions to engage in proactive behavior following a message about a health threat. Specifically, we propose to examine whether selfaffirmation 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 five or more alcoholic beverage in the past week) will be randomly assigned to write about an emotional event (something that made them happy, fearful, angry, or surprised) or to a neutral emotion condition (writing about a room in their house). Then, they will be randomly assigned to selfaffirm (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 fearful or surprising experience.
Study design
- Observational model
- Other
- 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 (3 listed)
- Women who have never been diagnosed with cancer and who drank 5 + alcoholic beverages in the past week will be eligible to participate. All men, and women who report a lower threshold of alcohol consumption, will be excluded.
- Children will be excluded from this study.
- Participants who have completed prior self-affirmation studies through GfK (e.g., the one conducted under 12-C-N162-B) will also be excluded; these participants will be identified by GfK (based on records of study participation kept for panel members), and will not be invited to participate in the current study.
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.
Primary outcome
Alcohol cessation intentions
Time frame: immediately post-experiment
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 19025270Epton T, Harris PR. Self-affirmation promotes health behavior change. Health Psychol. 2008 Nov;27(6):746-52. doi: 10.1037/0278-6133.27.6.746.
- Background: PubMed 11474720Lerner JS, Keltner D. Fear, anger, and risk. J Pers Soc Psychol. 2001 Jul;81(1):146-59. doi: 10.1037//0022-3514.81.1.146.
- Background: PubMed 16055644Harris PR, Napper L. Self-affirmation and the biased processing of threatening health-risk information. Pers Soc Psychol Bull. 2005 Sep;31(9):1250-63. doi: 10.1177/0146167205274694.
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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 Risk Reduction Behavior, 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 3 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 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.
What does the primary outcome measure?
Alcohol cessation intentions (time frame: immediately post-experiment). 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 NCT02311400, 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.