- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01652508
Acceptance and Commitment Therapy for Smoking Cessation in the Primary Care Setting (ACT)
October 26, 2017 updated by: Dr. Yim Wah Mak, The Hong Kong Polytechnic University
Individual, Telephone-delivered Acceptance and Commitment Therapy for Smoking Cessation in the Primary Healthcare Setting: Feasibility and Potential Efficacy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
156
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kowloon
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Hung Hom, Kowloon, Hong Kong
- School of Nursing, The Hong Kong Polytechnic University
-
-
New Territories
-
Tai Po, New Territories, Hong Kong
- United Christian Nethersole Community Health Service, Kwong Fuk Community Health Centre
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Tin Shui Wai, New Territories, Hong Kong
- Heavenly Joy Family Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control
Participants are given printed self-help leaflet on smoking cessation developed by the Department of Health, Hong Kong.
|
Participants in the control group are provided a self-help leaflet on smoking cessation only
Other Names:
|
|
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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
at 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
at 6 months after the baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
July 26, 2012
First Submitted That Met QC Criteria
July 26, 2012
First Posted (Estimate)
July 30, 2012
Study Record Updates
Last Update Posted (Actual)
October 30, 2017
Last Update Submitted That Met QC Criteria
October 26, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HHSRF9101421
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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