Trial of the Smoking Cessation Volitional Help Sheet in Primary Care

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02454621
• Other study ID #: MAN-CA-01
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: May 19, 2015
• Last updated: November 30, 2015
• Start date: May 2015
• Est. completion date: December 2015

Study information

• Verified date: November 2015
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• smoker

Exclusion Criteria:

• younger than 18 years

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Sandwell and West Birmingham CCG	Birmingham	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
University of Manchester

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quitting smoking	Self-reported smoking cessation	1 month	No
Primary	Nicotine dependence	Self-reported nicotine dependence	1 month	No
Secondary	Habit	Self-reported habit (e.g., "Smoking is something I do automatically: strongly disagree-strongly agree")	1 month	No
Secondary	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")	1 month	No
Secondary	Craving	Self-reported craving	1 month	No
Secondary	Self-identity	Self-reported self-identity (e.g., "Smoking is an important part of who I am: strongly disagree-strongly agree")	1 month	No