Smoking CessationACTNCT01652508
Acceptance and Commitment Therapy for Smoking Cessation in the Primary Care Setting
A study testing Acceptance and Commitment Therapy in people with Smoking Cessation, run by The Hong Kong Polytechnic University at 3 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 3 sitesHong Kong
- Study dates
- Jul 2012to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- currently undergoing another smoking cessation or similar program
Trial locations and contacts
3 sites in 1 country.
Hong Kong3 sites
School of Nursing, The Hong Kong Polytechnic University
Hung Hom, Kowloon
United Christian Nethersole Community Health Service, Kwong Fuk Community Health Centre
Tai Po, New Territories
Heavenly Joy Family Clinic
Tin Shui Wai, New Territories
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Control, Acceptance and Commitment Therapy
- Keywords
- smoking cessation, Acceptance and Commitment Therapy, primary care setting, randomised controlled trial
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Also called Control intervention
Participants in the control group are provided a self-help leaflet on smoking cessation only
Acceptance and Commitment TherapyBehavioural
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 group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Participants are given printed self-help leaflet on smoking cessation developed by the Department of Health, Hong Kong. Receives: Other: Control |
| Acceptance and Commitment Therapy | Experimental | 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. Receives: Behavioral: Acceptance and Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence by self report
self-reports on stopped smoking for a consecutive 7 days proceeding to the assessment at 6 months post-intervention
Measured: at 6 months
Secondary outcomes (1)
validated self-report not smoking measured
Obtaining CO measurement and testing urinary cotinine for those participants who report quitting smoking
Measured: at 6 months after the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Health Bureau, Hong Kong
- Responsible party
- Principal investigator, Dr. Yim Wah Mak, The Hong Kong Polytechnic University
- Investigators
- YW Mak, PhD, Principal investigator, School of Nursing, The Hong Kong Polytechnic UniversityAY Loke, PhD, Principal investigator, School of Nursing, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652508
- Sponsor's protocol ID
- HHSRF9101421
- Acronym
- ACT
- Status last verified
- Oct 2017
- First submitted
- 26 Jul 2012
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 26701301Mak 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.
PubMed 25879419Jackson 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.
PubMed 35420700Mak 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.
PubMed 33198700
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual, Telephone-delivered Acceptance and Commitment Therapy for Smoking Cessation in the Primary Healthcare Setting: Feasibility and Potential Efficacy
- ClinicalTrials.gov ID
- NCT01652508
- Acronym / sponsor ID
- ACT / HHSRF9101421
- Conditions
- Smoking Cessation
- Keywords
- smoking cessation, Acceptance and Commitment Therapy, primary care setting, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Food and Health Bureau, Hong Kong
- Study start
- Jul 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: ControlParticipants are given printed self-help leaflet on smoking cessation developed by the Department of Health, Hong Kong. |
| Acceptance and Commitment Therapy | Experimental | Behavioral: Acceptance and Commitment TherapyAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- currently undergoing another smoking cessation or similar program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlAlso: Control interventionParticipants in the control group are provided a self-help leaflet on smoking cessation only | Other | Control |
| Acceptance and Commitment TherapyAll 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). | Behavioural | Acceptance and Commitment Therapy |
Primary outcome
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
1 secondary outcome
validated self-report not smoking measured
Time frame: at 6 months after the baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
- Results publication: PubMed 26701301Mak 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.
- Results publication: PubMed 25879419Mak 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.
- Derived from this study: PubMed 35420700Jackson 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.
- Derived from this study: PubMed 33198700Mak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YW Mak, PhD principal investigator
School of Nursing, The Hong Kong Polytechnic University
AY Loke, PhD principal investigator
School of Nursing, The Hong Kong Polytechnic University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with Smoking Cessation, run by The Hong Kong Polytechnic University at 3 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point prevalence by self report (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01652508, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2017; AzTrials last refreshed its copy on 30 Oct 2026.