Acceptance and Commitment Therapy for Smoking Cessation in the Primary Care Setting (ACT)

• ClinicalTrials.gov Identifier: NCT01652508
• Recruitment Status: Completed
• First Posted: July 30, 2012
• Last Update Posted: October 30, 2017
• Sponsor: The Hong Kong Polytechnic University
• Collaborator: Food and Health Bureau, Hong Kong
• Information provided by (Responsible Party): Dr. Yim Wah Mak, The Hong Kong Polytechnic University

Tracking Information

• First Submitted Date: July 26, 2012
• First Posted Date: July 30, 2012
• Last Update Posted Date: October 30, 2017
• Study Start Date: July 2012
• Actual Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 26, 2017)

7-day point prevalence by self report [ Time Frame: at 6 months ]

self-reports on stopped smoking for a consecutive 7 days proceeding to the assessment at 6 months post-intervention

• Original Primary Outcome Measures (submitted: July 26, 2012): 7-day point prevalence by self report [ Time Frame: at 6 months ]

Current Secondary Outcome Measures (submitted: July 26, 2012)

validated self-report not smoking measured [ Time Frame: at 6 months after the baseline ]

Obtaining CO measurement and testing urinary cotinine for those participants who report quitting smoking

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: July 26, 2012)

Feasibility outcomes [ Time Frame: 1 year ]

Feasibility outcomes will be assessed in terms of participant recruitment, programme attendance and retention, their acceptance of physical cravings, emotions and thoughts related to smoking

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Acceptance and Commitment Therapy for Smoking Cessation in the Primary Care Setting
• Official Title: Individual, Telephone-delivered Acceptance and Commitment Therapy for Smoking Cessation in the Primary Healthcare Setting: Feasibility and Potential Efficacy
• Brief Summary: The purpose of this study is to evaluate the feasibility and potential efficacy of Acceptance and Commitment Therapy (ACT) in enhancing smoking cessation among attendees in primary healthcare settings.
• Detailed Description: The program is preventive and corrective, and carries brief messages by approaching and influencing services attendees who may not be able to reach in traditional reactive approach method of service users. Those traditional approaches are, for example, quitline and smoking cessation clinic. It can therefore benefit a larger population at low cost.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Health Services Research
• Condition: Smoking Cessation

Intervention

• Other: Control
  Participants in the control group are provided a self-help leaflet on smoking cessation only
  Other Name: Control intervention
• Behavioral: Acceptance and Commitment Therapy
  All participants are given an initial smoking cessation session via face to face by Acceptance and Commitment Therapy. Two other sessions using the same therapy will be provided by telephone. The total contact time by ACT will be 45 mins (15 mins per session).

Study Arms

• Placebo Comparator: Control
  Participants are given printed self-help leaflet on smoking cessation developed by the Department of Health, Hong Kong.
  Intervention: Other: Control
• Experimental: Acceptance and Commitment Therapy
  All participants are given a self-help leaflet on smoking cessation. Participants are also given an initial session of face-to-face ACT at a primary health service clinic. In addition, two more subsequent ACT sessions are provided by telephone at one week and one month after the initial intervention.
  Intervention: Behavioral: Acceptance and Commitment Therapy

Publications *

• Mak YW, Lee PH, Loke AY. Predictors of participation in a telephone-based Acceptance and Commitment Therapy for smoking cessation study. BMC Public Health. 2015 Dec 23;15:1288. doi: 10.1186/s12889-015-2650-0.
• Mak YW, Loke AY. The acceptance and commitment therapy for smoking cessation in the primary health care setting: a study protocol. BMC Public Health. 2015 Feb 7;15:105. doi: 10.1186/s12889-015-1485-z.
• Mak YW, Leung DYP, Loke AY. Effectiveness of an individual acceptance and commitment therapy for smoking cessation, delivered face-to-face and by telephone to adults recruited in primary health care settings: a randomized controlled trial. BMC Public Health. 2020 Nov 16;20(1):1719. doi: 10.1186/s12889-020-09820-0.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 26, 2012): 156
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 2015
• Actual Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• aged 18 years and older
• currently smoking at least one cigarette per day in the past 30 days
• Hong Kong residents
• able to communicate in Cantonese
• currently residing in Hong Kong and expecting to continue to do so for the next 6 months
• have access to a telephone

Exclusion Criteria:

• currently undergoing another smoking cessation or similar program

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Hong Kong

Administrative Information

• NCT Number: NCT01652508
• Other Study ID Numbers: HHSRF9101421
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Dr. Yim Wah Mak, The Hong Kong Polytechnic University
• Study Sponsor: The Hong Kong Polytechnic University
• Collaborators: Food and Health Bureau, Hong Kong

Investigators

• Principal Investigator: YW Mak, PhD; School of Nursing, The Hong Kong Polytechnic University
• Principal Investigator: AY Loke, PhD; School of Nursing, The Hong Kong Polytechnic University

• PRS Account: The Hong Kong Polytechnic University
• Verification Date: October 2017