Exploring Whether Self-affirmation Promotes Reduced Alcohol Consumption in Response to Narrative Health Information

Alcohol Drinking Clinical Trial

Official title:

Exploring Whether Experimentally Manipulated Self-affirmation Promotes Reduced Alcohol Consumption in Response to Narrative Health Information

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02681900
• Other study ID #: ER/KJF25/4
• Status: Completed
• Phase: N/A
• First received: February 2, 2016
• Last updated: February 9, 2016
• Start date: October 2014
• Est. completion date: December 2014

Study information

• Verified date: February 2016
• Source: University of Sussex
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Councils UK
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female

• Drinkers

Exclusion Criteria:

• Male

• Non-drinkers

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcohol Drinking

Intervention

Behavioral:
• Self-affirmation manipulation task
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.
• Control task
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.

Locations

Country	Name	City	State
United Kingdom	University of Sussex	Falmer	Brighton

Sponsors (2)

Lead Sponsor	Collaborator
University of Sussex	Economic and Social Research Council, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol consumption 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	No
Secondary	Effect of intervention on acceptance of health information	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	No
Secondary	Effect of intervention on engagement with health information	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	No