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

Primary Purpose

Alcohol Drinking

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Self-affirmation manipulation task
Control task
Sponsored by
University of Sussex
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female
  • Drinkers

Exclusion Criteria:

  • Male
  • Non-drinkers

Sites / Locations

  • University of Sussex

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Self-affirmation

Control

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 2, 2016
Last Updated
February 9, 2016
Sponsor
University of Sussex
Collaborators
Economic and Social Research Council, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT02681900
Brief Title
Exploring Whether Self-affirmation Promotes Reduced Alcohol Consumption in Response to Narrative Health Information
Official Title
Exploring Whether Experimentally Manipulated Self-affirmation Promotes Reduced Alcohol Consumption in Response to Narrative Health Information
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sussex
Collaborators
Economic and Social Research Council, United Kingdom

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-affirmation
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-affirmation manipulation task
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control task
Intervention Description
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.
Primary Outcome Measure Information:
Title
Alcohol consumption 7 days after intervention
Description
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).
Time Frame
7 days after intervention
Secondary Outcome Measure Information:
Title
Effect of intervention on acceptance of health information
Description
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.
Time Frame
Immediately after intervention
Title
Effect of intervention on engagement with health information
Description
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.
Time Frame
Immediately after intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female Drinkers Exclusion Criteria: Male Non-drinkers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry J Fox, MSc
Organizational Affiliation
University of Sussex
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sussex
City
Falmer
State/Province
Brighton
ZIP/Postal Code
BN1 9RH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28484982
Citation
Fox KJ, Harris PR, Jessop DC. Experimentally Manipulated Self-Affirmation Promotes Reduced Alcohol Consumption in Response to Narrative Information. Ann Behav Med. 2017 Dec;51(6):931-935. doi: 10.1007/s12160-017-9912-2.
Results Reference
derived

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

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