Smoking CessationNCT03295409
Testing Familial Self-affirmation for Smoking Cessation
A study testing Self-affirmation in people with Smoking Cessation, run by University of Manchester at 2 sites in Hong Kong.
Trial summary
Evidence suggests that affirming the self can help people to make changes in their health behavior. Typically, people affirm a personally-important value, but evidence suggests that affirming the values of family ("familial self-affirmation") might exert stronger effects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Self-affirmation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Oct 2017to 31 Mar 2018
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Smoker
Who cannot join
- Non-smoker
- Unable or unwilling to complete questionnaire
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
HC Engineering Company
Hong Kong
Perfect Match Wedding Service
Hong Kong
About this study
Evidence suggests that affirming the self can help people to make changes in their health behavior. Typically, people affirm a personally-important value, but evidence suggests that affirming the values of family ("familial self-affirmation") might exert stronger effects. The aim of the present study is to examine the effects of familial self-affirmation versus standard self-affirmation versus a control group on smoking cessation.
- Conditions
- Smoking Cessation
- Being tested
- Self-affirmation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-affirmationBehavioural
Participants are asked to complete a standard questionnaire and on the last page they are asked to form a self-affirming implementation intention by copying out a sentence.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Standard self-affirmation | Experimental | Participants are asked to form a self-affirming implementation intention at the end of a questionnaire:
The beginning to a sentence appears below. Below it are 4 different ways of completing the sentence. On the lines below, please write out the beginning of the sentence and then complete it with 1 of the 4 options we have given you.
If I feel threatened or anxious, then I will…
* think about the things I value about myself
* remember things that I have succeeded in
* think about what I stand for
* think about things that are important to me
If…___________________________________________________________________ Receives: Behavioral: Self-affirmation |
| Experimental: Familial self-affirmation | Experimental | Participants are asked to form a self-affirming implementation intention at the end of a questionnaire:
The beginning to a sentence appears below. Below it are 4 different ways of completing the sentence. On the lines below, please write out the beginning of the sentence and then complete it with 1 of the 4 options we have given you.
If I feel threatened or anxious, then I will…
* think about the things my family and I value about ourselves
* remember things that my family and I have succeeded in
* think about what my family and I stand for
* think about things that are important to my family and me
If…__________________________________________________________________ Receives: Behavioral: Self-affirmation |
| Control | No intervention | Participants are asked to complete a questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation
Self-reported quitting
Measured: 1 month
Quit attempts
Self-reported quit attempts
Measured: 1 month
Nicotine dependence
Self-reported nicotine dependence
Measured: 1 month
Craving
Self-reported cravings
Measured: 1 month
Secondary outcomes (3)
Habit
Self-reported habit
Measured: 1 month
Self-regulation
Self-reported self-regulation
Measured: 1 month
Subjective well-being
Self-reported subjective well-being
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start1 Oct 2017
- Primary completion28 Feb 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Armitage, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295409
- Sponsor's protocol ID
- Chun_1
- Status last verified
- May 2018
- First submitted
- 22 Sep 2017
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymised SPSS file
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Familial Self-affirmation for Smoking Cessation
- ClinicalTrials.gov ID
- NCT03295409
- Acronym / sponsor ID
- Chun_1
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 27 Sep 2017 (actual)
- 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.
Evidence suggests that affirming the self can help people to make changes in their health behavior. Typically, people affirm a personally-important value, but evidence suggests that affirming the values of family ("familial self-affirmation") might exert stronger effects. The aim of the present study is to examine the effects of familial self-affirmation versus standard self-affirmation versus a control group on smoking cessation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: Standard self-affirmation | Experimental | Behavioral: Self-affirmationParticipants are asked to form a self-affirming implementation intention at the end of a questionnaire: The beginning to a sentence appears below. Below it are 4 different ways of completing the sentence. On the lines below, please write out the beginning of the sentence and then complete it with 1 of the 4 options we have given you. If I feel threatened or anxious, then I will… * think about the things I value about myself * remember things that I have succeeded in * think about what I stand for * think about things that are important to me If…___________________________________________________________________ |
| Experimental: Familial self-affirmation | Experimental | Behavioral: Self-affirmationParticipants are asked to form a self-affirming implementation intention at the end of a questionnaire: The beginning to a sentence appears below. Below it are 4 different ways of completing the sentence. On the lines below, please write out the beginning of the sentence and then complete it with 1 of the 4 options we have given you. If I feel threatened or anxious, then I will… * think about the things my family and I value about ourselves * remember things that my family and I have succeeded in * think about what my family and I stand for * think about things that are important to my family and me If…__________________________________________________________________ |
| Control | No intervention | –Participants are asked to complete a questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Smoker
Key exclusion criteria (2 listed)
- Non-smoker
- Unable or unwilling to complete questionnaire
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-affirmationParticipants are asked to complete a standard questionnaire and on the last page they are asked to form a self-affirming implementation intention by copying out a sentence. | Behavioural | Experimental: Familial self-affirmation, Experimental: Standard self-affirmation |
Primary outcome
Smoking cessation
Time frame: 1 month
Self-reported quitting
Quit attempts
Time frame: 1 month
Self-reported quit attempts
Nicotine dependence
Time frame: 1 month
Self-reported nicotine dependence
Craving
Time frame: 1 month
Self-reported cravings
3 secondary outcomes
Habit
Time frame: 1 month
Self-regulation
Time frame: 1 month
Subjective well-being
Time frame: 1 month
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 2 May 2018.
- Individual participant dataSharing planned: Undecided. Anonymised SPSS file
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-affirmation in people with Smoking Cessation, run by University of Manchester at 2 sites in Hong Kong.
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 1 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 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. 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?
Smoking cessation (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 May 2018; AzTrials last refreshed its copy on 4 Nov 2026.