NCT01652508

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

October 30, 2017

Status Verified

October 1, 2017

Enrollment Period

2.8 years

First QC Date

July 26, 2012

Last Update Submit

October 26, 2017

Conditions

Smoking Cessation

Keywords

smoking cessationAcceptance and Commitment Therapyprimary care settingrandomised controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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

    at 6 months

Secondary Outcomes (1)

  • validated self-report not smoking measured

    at 6 months after the baseline

Other Outcomes (1)

  • Feasibility outcomes

    1 year

Study Arms (2)

Control

PLACEBO COMPARATOR

Participants are given printed self-help leaflet on smoking cessation developed by the Department of Health, Hong Kong.

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.

Behavioral: Acceptance and Commitment Therapy

Interventions

ControlOTHER

Participants in the control group are provided a self-help leaflet on smoking cessation only

Also known as: Control intervention
Control
Acceptance and Commitment TherapyBEHAVIORAL

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).

Acceptance and Commitment Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • currently undergoing another smoking cessation or similar program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

School of Nursing, The Hong Kong Polytechnic University

Hung Hom, Kowloon, Hong Kong

Location

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

Tai Po, New Territories, Hong Kong

Location

Heavenly Joy Family Clinic

Tin Shui Wai, New Territories, Hong Kong

Location

Related Publications (4)

  • 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.

    PMID: 26701301RESULT

  • 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.

    PMID: 25879419RESULT

  • 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.

    PMID: 35420700DERIVED

  • 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.

    PMID: 33198700DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • YW Mak, PhD

    School of Nursing, The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

  • AY Loke, PhD

    School of Nursing, The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 26, 2012

First Posted

July 30, 2012

Study Start

July 1, 2012

Primary Completion

April 1, 2015

Study Completion

June 1, 2015

Last Updated

October 30, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

HK(3)