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Trial record 1 of 20 for:    acceptance commitment smoking cessation
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Acceptance and Commitment Therapy for Smoking Cessation in the Primary Care Setting (ACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01652508
Recruitment Status : Completed
First Posted : July 30, 2012
Last Update Posted : October 30, 2017
Sponsor:
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  ICMJE July 26, 2012
First Posted Date  ICMJE July 30, 2012
Last Update Posted Date October 30, 2017
Study Start Date  ICMJE July 2012
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: July 26, 2012)
7-day point prevalence by self report [ Time Frame: at 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE 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  ICMJE Acceptance and Commitment Therapy for Smoking Cessation in the Primary Care Setting
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • 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  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2012)
156
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01652508
Other Study ID Numbers  ICMJE HHSRF9101421
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Yim Wah Mak, The Hong Kong Polytechnic University
Study Sponsor  ICMJE The Hong Kong Polytechnic University
Collaborators  ICMJE Food and Health Bureau, Hong Kong
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP