Trial of the Smoking Cessation Volitional Help Sheet in Primary Care

NCT02454621 | Withdrawn Phase 1

• 1 other identifier: MAN-CA-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (2)

• Quitting smoking

  Self-reported smoking cessation

  1 month

• Nicotine dependence

  Self-reported nicotine dependence

  1 month

Secondary Outcomes (4)

• Habit

  1 month

• Action control

  1 month

• Craving

  1 month

• Self-identity

  1 month

Study Arms (2)

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.

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.

Behavioral: Volitional help sheet

Interventions

Volitional help sheet BEHAVIORAL

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

Control; Volitional help sheet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• smoker

You may not qualify if:

• younger than 18 years

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

Sandwell and West Birmingham CCG

Birmingham, West Midlands, B70 9LD, United Kingdom

Location

Related 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.

  PMID: 18823182 RESULT

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Christopher Armitage, PhD

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Health Psychology

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: May 27, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

GB (1)