Acceptance and Commitment Therapy for Smoking Cessation in the Primary Care Setting (ACT)
This study is currently recruiting participants.
Verified July 2012 by The Hong Kong Polytechnic University
Sponsor:
The Hong Kong Polytechnic University
Collaborator:
Food and Health Bureau, Hong Kong Special Administrative Region
Information provided by (Responsible Party):
Dr. Yim Wah Mak, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT01652508
First received: July 26, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 26, 2012 | ||||||||
| Last Updated Date | July 26, 2012 | ||||||||
| Start Date ICMJE | July 2012 | ||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
7-day point prevalence by self report [ Time Frame: at 6 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
validated self-report not smoking measured [ Time Frame: at 6 months after the baseline ] [ Designated as safety issue: No ] Obtaining CO measurement and testing urinary cotinine for those participants who report quitting smoking |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE |
Feasibility outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ] 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 |
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| Original Other Outcome Measures ICMJE | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Health Services Research |
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| Condition ICMJE | Smoking Cessation | ||||||||
| Intervention ICMJE | Behavioral: ACT
Participants in the intervention group will be provided three sessions of ACT for smoking cessation. Initial ACT session will be given at the centre which will take about 15-20 minutes. The two subsequent sessions will be provided by telephone.
Other Name: Acceptance and Commitment Therapy |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 156 | ||||||||
| Estimated Completion Date | September 2013 | ||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Hong Kong | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01652508 | ||||||||
| Other Study ID Numbers ICMJE | HHSRF9101421 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| 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 Special Administrative Region | ||||||||
| Investigators ICMJE |
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| Information Provided By | The Hong Kong Polytechnic University | ||||||||
| Verification Date | July 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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