Alcohol DrinkingNCT02681900
Exploring Whether Self-affirmation Promotes Reduced Alcohol Consumption in Response to Narrative Health Information
A study testing Self-affirmation manipulation task in people with Alcohol Drinking, run by University of Sussex at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Self-affirmation manipulation task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to Dec 2014
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Drinkers
Who cannot join
- Male
- Non-drinkers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Alcohol Drinking
- Being tested
- Self-affirmation manipulation task, Control task
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-affirmation manipulation taskBehavioural
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 taskBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-affirmation | Experimental | 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. Receives: Behavioral: Self-affirmation manipulation task |
| Control | Active comparator | 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. Receives: Behavioral: Control task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 7 days after intervention
Secondary outcomes (2)
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.
Measured: Immediately after intervention
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.
Measured: Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startOct 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sussex
- Sponsor type
- University, hospital or other
- Collaborators
- Economic and Social Research Council, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Kerry J Fox, MSc, Principal investigator, University of Sussex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681900
- Sponsor's protocol ID
- ER/KJF25/4
- Status last verified
- Feb 2016
- First submitted
- 2 Feb 2016
- Last updated
- 15 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28484982
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Whether Experimentally Manipulated Self-affirmation Promotes Reduced Alcohol Consumption in Response to Narrative Health Information
- ClinicalTrials.gov ID
- NCT02681900
- Acronym / sponsor ID
- ER/KJF25/4
- Conditions
- Alcohol Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University of SussexUniversity, hospital or other
- Collaborators
- Economic and Social Research Council, United Kingdom
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Feb 2016 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-affirmation | Experimental | Behavioral: Self-affirmation manipulation taskParticipants 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. |
| Control | Active comparator | Behavioral: Control taskParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female
- Drinkers
Key exclusion criteria (2 listed)
- Male
- Non-drinkers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-affirmation manipulation taskParticipants 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. | Behavioural | Self-affirmation |
| Control taskPeople 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. | Behavioural | Control |
Primary outcome
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).
2 secondary outcomes
Effect of intervention on acceptance of health information
Time frame: Immediately after intervention
Effect of intervention on engagement with health information
Time frame: Immediately after intervention
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 15 Feb 2016.
- Derived from this study: PubMed 28484982Fox 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.
- Individual participant dataSharing planned: Undecided
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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.
Kerry J Fox, MSc principal investigator
University of Sussex
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-affirmation manipulation task in people with Alcohol Drinking, run by University of Sussex at 1 site in United Kingdom.
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 15 Feb 2016. 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 Kingdom. 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 consumption 7 days after intervention (time frame: 7 days after intervention). 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 NCT02681900, which also lists 1 linked publication.
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 15 Feb 2016.