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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Smoking Cessation	Other: Control; Behavioral: Acceptance and Commitment Therapy	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 156 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Health Services Research
• Official Title: Individual, Telephone-delivered Acceptance and Commitment Therapy for Smoking Cessation in the Primary Healthcare Setting: Feasibility and Potential Efficacy
• Study Start Date: July 2012
• Actual Primary Completion Date: April 2015
• Actual Study Completion Date: June 2015

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Control; Participants are given printed self-help leaflet on smoking cessation developed by the Department of Health, Hong Kong.	Other: Control; Participants in the control group are provided a self-help leaflet on smoking cessation only; Other Name: Control intervention
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.	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).

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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

Other Outcome Measures:

1. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Hong Kong

School of Nursing, The Hong Kong Polytechnic University

Hung Hom, Kowloon, Hong Kong

United Christian Nethersole Community Health Service, Kwong Fuk Community Health Centre

Tai Po, New Territories, Hong Kong

Heavenly Joy Family Clinic

Tin Shui Wai, New Territories, Hong Kong

Sponsors and Collaborators

The Hong Kong Polytechnic University

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

More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Dr. Yim Wah Mak, Assistant Professor, The Hong Kong Polytechnic University
• ClinicalTrials.gov Identifier: NCT01652508
• Other Study ID Numbers: HHSRF9101421
• First Posted: July 30, 2012
• Last Update Posted: October 30, 2017
• Last Verified: October 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Dr. Yim Wah Mak, The Hong Kong Polytechnic University:

smoking cessation; Acceptance and Commitment Therapy; primary care setting; randomised controlled trial