- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02681900
Exploring Whether Self-affirmation Promotes Reduced Alcohol Consumption in Response to Narrative Health Information
February 9, 2016 updated by: University of Sussex
Exploring Whether Experimentally Manipulated Self-affirmation Promotes Reduced Alcohol Consumption in Response to Narrative Health Information
This study tests the effects of a self-affirmation manipulation on (i) acceptance of a health message detailing the risks of alcohol consumption, (ii) engagement with the health message and (iii) alcohol consumption at 7-day follow-up.
Half of the participants complete a self-affirmation manipulation, where they reflect on their most important values, whereas the other half complete a control equivalent, where they reflect on their least important values.
Immediately post-intervention, all participants then receive information about the risks of alcohol consumption and complete measures of message acceptance and engagement with the materials.
Seven days after intervention, participants self-report their alcohol consumption in the previous 7 days.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
142
Phase
- Not Applicable
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
-
-
Brighton
-
Falmer, Brighton, United Kingdom, BN1 9RH
- University of Sussex
-
-
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 and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female
- Drinkers
Exclusion Criteria:
- Male
- Non-drinkers
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
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Self-affirmation
Participants in the self-affirmation arm write about their most important value, reasons why is important and an example of when they enacted that value.
This is the Self-affirmation manipulation task as described in the intervention.
|
Participants in the self-affirmation condition indicate their most important value, give three examples of why this value is important to them and one example of something they had done to demonstrate its importance.
|
|
ACTIVE_COMPARATOR: Control
Participants in this arm complete a control equivalent of the self-affirmation task, where they write about their least important value, reasons why is may be important to someone else and an example of when another person may have enacted that value.
This is the Control task as described in the intervention.
|
People in the control condition indicate their least important value, three examples of why that value could be important to someone else, and describe something that person could do to show its importance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alcohol consumption 7 days after intervention
Time Frame: 7 days after intervention
|
Seven days after the intervention, participants are contacted and asked to report their alcohol consumption over the previous 7-day period via self-report items.
Participants report the type of alcohol (e.g., beer, spirit), type of container (e.g., small glass, pint, single measure) and the number of each type of drink they had consumed on each day over the previous 7 days using the adapted version (Armitage, Harris, & Arden, 2011) of the timeline fallback technique (Sobell & Sobell, 1992).
The total number of units consumed by each participant was then calculated using the UK NHS alcohol unit calculator (NHS Choices, 2013: www.nhs.uk/tools/pages/alcohol-unit-calculator.aspx).
|
7 days after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of intervention on acceptance of health information
Time Frame: Immediately after intervention
|
Measures to assess whether the intervention affected the extent to which people accepted information about the risks of alcohol consumption were taken immediately after the intervention via self-report items.
Acceptance items included personal relevance, negative affect, attitudes, anticipated regret and intentions.
Responses to items were given on 7-point scales with relevant anchors (e.g.
strongly disagree [1] to strongly agree [7]).
A mean score was calculated for each participant on each measure, with higher scores indicating greater levels of that construct.
|
Immediately after intervention
|
|
Effect of intervention on engagement with health information
Time Frame: Immediately after intervention
|
Measures to assess whether the intervention affected the extent to which people engaged with the information were taken immediately after the intervention via self-report items.
Engagement items included perspective taking, attention, emotion and visualization.
Responses to items were given on 7-point scales with relevant anchors (e.g.
strongly disagree [1] to strongly agree [7]).
A mean score was calculated for each participant on each measure, with higher scores indicating greater levels of that construct.
|
Immediately after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kerry J Fox, MSc, University of Sussex
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.
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
October 1, 2014
Primary Completion (ACTUAL)
December 1, 2014
Study Completion (ACTUAL)
December 1, 2014
Study Registration Dates
First Submitted
February 2, 2016
First Submitted That Met QC Criteria
February 9, 2016
First Posted (ESTIMATE)
February 15, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
February 15, 2016
Last Update Submitted That Met QC Criteria
February 9, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ER/KJF25/4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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