Smoking CessationPhase 1/2NCT02454621
Trial of the Smoking Cessation Volitional Help Sheet in Primary Care
A Phase 1/2 study testing Volitional help sheet in people with Smoking Cessation, run by University of Manchester at 1 site in United Kingdom.
Trial summary
The study will recruit patients who smoke from a general practice clinic and randomize them either to: (1) form implementation intentions by linking in memory situations in which they are tempted to smoke with strategies to avoid smoking in those situations using a volitional help sheet, or (2) to consider the… 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?
- Volitional help sheet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2015to Dec 2015
- Phase
- Phase 1/2
- 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
- younger than 18 years
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sandwell and West Birmingham CCG
Birmingham, West Midlands, B70 9LD
About this study
Official title: Randomized Controlled Trial of the Smoking Cessation Volitional Help Sheet in Primary Care
The study will recruit patients who smoke from a general practice clinic and randomize them either to: (1) form implementation intentions by linking in memory situations in which they are tempted to smoke with strategies to avoid smoking in those situations using a volitional help sheet, or (2) to consider the situations in which they are tempted to smoke alongside possible strategies to avoid smoking as presented in the volitional help sheet but not to form implementation intentions. The effects on self-reported smoking will be assessed 1 month post-intervention.
Read the detailed description
The study will recruit patients who smoke from a general practice clinic and randomize them either to: (1) form implementation intentions by linking in memory situations in which they are tempted to smoke with strategies to avoid smoking in those situations using a volitional help sheet, or (2) to consider the situations in which they are tempted to smoke alongside possible strategies to avoid smoking as presented in the volitional help sheet but not to form implementation intentions. The effects on self-reported smoking will be assessed 1 month post-intervention.
Design: This study will use questionnaires to assess participants smoking habits and then employ planning strategies to help then quit. Follow up questionnaires will be used to ascertain the success of planning on smoking cessation.
Sample Size: Upon entry to the General Practice (GP) clinic participants will be made aware of the study by the receptionist and asked to complete a copy if they are a smoker. The investigators are looking to recruit a minimum of fifty participants for each condition, but aim to collect data from as many participants as possible during the recruitment phase.
Recruitment: To participate in this study a person must be over the age of 18 and a smoker. The receptionists at the GP clinic will inform people of the study on entry and ask that they complete the questionnaire should they be 18 (or older) and smoke.
Procedure: Participants will be recruited from a GP clinic in Birmingham. They will be asked by the receptionists, upon entry to the clinic, to take one of the investigators' questionnaire packs if they are a smoker. These packs will be displayed on a table beside the reception desk. The packs begins with a briefing sheet that provides information about both how to complete the questionnaire and the reason for the study. The sheet will also inform participants that they do not have to complete the questionnaire that day, and they should feel free to come back and take part at a later date. It will also indicate to participants that they can withdraw from the study at any time, and a reason does not need to be provided. Once they have read the briefing sheet and generated their personal identity code, as instructed, they will complete the questionnaire. Completed questionnaires will be returned to the returns box. This will be securely stored in the GP clinic and collected once a week. Data from all packs will be collected and transferred to a secure university server before being shredded. A month after the participants have completed the initial questionnaire they will receive a follow-up questionnaire; either via e-mail or a hard copy via post where indicated. Data from the online questionnaire will be collected immediately, hard copy questionnaires will be returned via a pre-paid envelope (enclosed with the hard copy questionnaire) and transcribed onto a secure university computer before being shredded. Participants contact information will be kept separate from the data. Once participants have completed the follow-up questionnaire their involvement in the study is over.
Outcomes and Analysis: The main purpose of this study is to explore the role of planning in encouraging people to quit smoking when recruited by receptionists in a GP clinic. Quantitative analysis will be conducted to assess the effects of planning on smoking cessation. The investigators expect to find that planning is effective in helping people quit, and that the questionnaire is compatible for use within a healthcare setting.
- Conditions
- Smoking Cessation
- Being tested
- Volitional help sheet
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volitional help sheetBehavioural
Participants are asked to form implementation intentions using a volitional help sheet (Armitage, 2008).
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants read a brief statement designed to encourage them to quit smoking ("We want you to plan to quit smoking"). Participants are presented with a table with two columns and twenty rows. Twenty critical situations (temptations) are presented in the left hand column and 20 appropriate responses (processes of change) are presented in the right hand column (see Armitage, 2008). Participants are told that identifying situations in which they were tempted to smoke and identifying ways to overcome those temptations had been shown to promote smoking cessation and are asked to tick critical situations/appropriate responses that might be useful to them. Receives: Behavioral: Volitional help sheet |
| Volitional help sheet | Experimental | Participants read a brief statement designed to encourage them to quit smoking ("We want you to plan to quit smoking"). Participants are presented with a table with two columns and twenty rows. Twenty critical situations (temptations) are presented in the left hand column and 20 appropriate responses (processes of change) are presented in the right hand column (see Armitage, 2008). Participants are told that identifying situations in which they were tempted to smoke and identifying ways to overcome those temptations had been shown to promote smoking cessation. Implementation intentions are formed by linking critical situations with appropriate responses by drawing lines between critical situations and appropriate responses. Receives: Behavioral: Volitional help sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quitting smoking
Self-reported smoking cessation
Measured: 1 month
Nicotine dependence
Self-reported nicotine dependence
Measured: 1 month
Secondary outcomes (4)
Habit
Self-reported habit (e.g., "Smoking is something I do automatically: strongly disagree-strongly agree")
Measured: 1 month
Action control
Self-reported action control (e.g., "During the last week I often had my intention to quit smoking on my mind: strongly disagree-strongly agree")
Measured: 1 month
Craving
Self-reported craving
Measured: 1 month
Self-identity
Self-reported self-identity (e.g., "Smoking is an important part of who I am: strongly disagree-strongly agree")
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 May 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: The researcher quit the study
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 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 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
- Investigators
- Christopher Armitage, PhD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454621
- Sponsor's protocol ID
- MAN-CA-01
- Status last verified
- Nov 2015
- First submitted
- 19 May 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Armitage CJ. A volitional help sheet to encourage smoking cessation: a randomized exploratory trial. Health Psychol. 2008 Sep;27(5):557-66. doi: 10.1037/0278-6133.27.5.557.
PubMed 18823182
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of the Smoking Cessation Volitional Help Sheet in Primary Care
- ClinicalTrials.gov ID
- NCT02454621
- Acronym / sponsor ID
- MAN-CA-01
- Conditions
- Smoking Cessation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The researcher quit the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 27 May 2015 (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.
The study will recruit patients who smoke from a general practice clinic and randomize them either to: (1) form implementation intentions by linking in memory situations in which they are tempted to smoke with strategies to avoid smoking in those situations using a volitional help sheet, or (2) to consider the situations in which they are tempted to smoke alongside possible strategies to avoid smoking as presented in the volitional help sheet but not to form implementation intentions. The effects on self-reported smoking will be assessed 1 month post-intervention.
Detailed description
The study will recruit patients who smoke from a general practice clinic and randomize them either to: (1) form implementation intentions by linking in memory situations in which they are tempted to smoke with strategies to avoid smoking in those situations using a volitional help sheet, or (2) to consider the situations in which they are tempted to smoke alongside possible strategies to avoid smoking as presented in the volitional help sheet but not to form implementation intentions. The effects on self-reported smoking will be assessed 1 month post-intervention.
Design: This study will use questionnaires to assess participants smoking habits and then employ planning strategies to help then quit. Follow up questionnaires will be used to ascertain the success of planning on smoking cessation.
Sample Size: Upon entry to the General Practice (GP) clinic participants will be made aware of the study by the receptionist and asked to complete a copy if they are a smoker. The investigators are looking to recruit a minimum of fifty participants for each condition, but aim to collect data from as many participants as possible during the recruitment phase.
Recruitment: To participate in this study a person must be over the age of 18 and a smoker. The receptionists at the GP clinic will inform people of the study on entry and ask that they complete the questionnaire should they be 18 (or older) and smoke.
Procedure: Participants will be recruited from a GP clinic in Birmingham. They will be asked by the receptionists, upon entry to the clinic, to take one of the investigators' questionnaire packs if they are a smoker. These packs will be displayed on a table beside the reception desk. The packs begins with a briefing sheet that provides information about both how to complete the questionnaire and the reason for the study. The sheet will also inform participants that they do not have to complete the questionnaire that day, and they should feel free to come back and take part at a later date. It will also indicate to participants that they can withdraw from the study at any time, and a reason does not need to be provided. Once they have read the briefing sheet and generated their personal identity code, as instructed, they will complete the questionnaire. Completed questionnaires will be returned to the returns box. This will be securely stored in the GP clinic and collected once a week. Data from all packs will be collected and transferred to a secure university server before being shredded. A month after the participants have completed the initial questionnaire they will receive a follow-up questionnaire; either via e-mail or a hard copy via post where indicated. Data from the online questionnaire will be collected immediately, hard copy questionnaires will be returned via a pre-paid envelope (enclosed with the hard copy questionnaire) and transcribed onto a secure university computer before being shredded. Participants contact information will be kept separate from the data. Once participants have completed the follow-up questionnaire their involvement in the study is over.
Outcomes and Analysis: The main purpose of this study is to explore the role of planning in encouraging people to quit smoking when recruited by receptionists in a GP clinic. Quantitative analysis will be conducted to assess the effects of planning on smoking cessation. The investigators expect to find that planning is effective in helping people quit, and that the questionnaire is compatible for use within a healthcare setting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Volitional help sheetParticipants read a brief statement designed to encourage them to quit smoking ("We want you to plan to quit smoking"). Participants are presented with a table with two columns and twenty rows. Twenty critical situations (temptations) are presented in the left hand column and 20 appropriate responses (processes of change) are presented in the right hand column (see Armitage, 2008). Participants are told that identifying situations in which they were tempted to smoke and identifying ways to overcome those temptations had been shown to promote smoking cessation and are asked to tick critical situations/appropriate responses that might be useful to them. |
| Volitional help sheet | Experimental | Behavioral: Volitional help sheetParticipants read a brief statement designed to encourage them to quit smoking ("We want you to plan to quit smoking"). Participants are presented with a table with two columns and twenty rows. Twenty critical situations (temptations) are presented in the left hand column and 20 appropriate responses (processes of change) are presented in the right hand column (see Armitage, 2008). Participants are told that identifying situations in which they were tempted to smoke and identifying ways to overcome those temptations had been shown to promote smoking cessation. Implementation intentions are formed by linking critical situations with appropriate responses by drawing lines between critical situations and appropriate responses. |
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 (1 listed)
- younger than 18 years
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 |
|---|---|---|
| Volitional help sheetParticipants are asked to form implementation intentions using a volitional help sheet (Armitage, 2008). | Behavioural | Control, Volitional help sheet |
Primary outcome
Quitting smoking
Time frame: 1 month
Self-reported smoking cessation
Nicotine dependence
Time frame: 1 month
Self-reported nicotine dependence
4 secondary outcomes
Habit
Time frame: 1 month
Action control
Time frame: 1 month
Craving
Time frame: 1 month
Self-identity
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Results publication: PubMed 18823182Armitage CJ. A volitional help sheet to encourage smoking cessation: a randomized exploratory trial. Health Psychol. 2008 Sep;27(5):557-66. doi: 10.1037/0278-6133.27.5.557.
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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.
Christopher Armitage, PhD principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Volitional help sheet in people with Smoking Cessation, run by University of Manchester 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 2 Dec 2015. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Quitting smoking (time frame: 1 month). The study lists 2 primary outcomes in all. 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 NCT02454621, 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 2 Dec 2015.