Trial of the Smoking Cessation Volitional Help Sheet in Primary Care

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.

Study Overview

• Status: Withdrawn
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Volitional help sheet

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 Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B70 9LD
      • Sandwell and West Birmingham CCG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• smoker

Exclusion Criteria:

• younger than 18 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control; 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.	Behavioral: Volitional help sheet; Participants are asked to form implementation intentions using a volitional help sheet (Armitage, 2008).
EXPERIMENTAL: Volitional help sheet; 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.	Behavioral: Volitional help sheet; Participants are asked to form implementation intentions using a volitional help sheet (Armitage, 2008).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nicotine dependence	Self-reported nicotine dependence	1 month
Quitting smoking	Self-reported smoking cessation	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Habit	Self-reported habit (e.g., "Smoking is something I do automatically: strongly disagree-strongly agree")	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")	1 month
Craving	Self-reported craving	1 month
Self-identity	Self-reported self-identity (e.g., "Smoking is an important part of who I am: strongly disagree-strongly agree")	1 month

Collaborators and Investigators

• Sponsor: University of Manchester

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (ANTICIPATED): December 1, 2015
• Study Completion (ANTICIPATED): December 1, 2015

Study Registration Dates

• First Submitted: May 19, 2015
• First Submitted That Met QC Criteria: May 21, 2015
• First Posted (ESTIMATE): May 27, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): December 2, 2015
• Last Update Submitted That Met QC Criteria: November 30, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: MAN-CA-01