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Trial of the Smoking Cessation Volitional Help Sheet in Primary Care

Randomized Controlled Trial of the Smoking Cessation Volitional Help Sheet in Primary Care

Status
Withdrawn
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02454621
Enrollment
0
Registered
2015-05-27
Start date
2015-05-31
Completion date
2015-12-31
Last updated
2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Brief 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 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.

Interventions

Participants are asked to form implementation intentions using a volitional help sheet (Armitage, 2008).

Sponsors

University of Manchester
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* smoker

Exclusion criteria

* younger than 18 years

Design outcomes

Primary

MeasureTime frameDescription
Quitting smoking1 monthSelf-reported smoking cessation
Nicotine dependence1 monthSelf-reported nicotine dependence

Secondary

MeasureTime frameDescription
Habit1 monthSelf-reported habit (e.g., Smoking is something I do automatically: strongly disagree-strongly agree)
Action control1 monthSelf-reported action control (e.g., During the last week I often had my intention to quit smoking on my mind: strongly disagree-strongly agree)
Craving1 monthSelf-reported craving
Self-identity1 monthSelf-reported self-identity (e.g., Smoking is an important part of who I am: strongly disagree-strongly agree)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026