NCT03253445

Brief Summary

The purpose of this study is to evaluate the efficacy of using Acceptance and commitment therapy for smoking cessation for schizophrenic patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2016

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 17, 2017

Status Verified

August 1, 2017

Enrollment Period

3.4 years

First QC Date

March 18, 2016

Last Update Submit

August 15, 2017

Conditions

Smoking Cessation

Keywords

smoking cessationacceptance and commitment therapyACTschizophrenic patientshostel settingrandomised controlled trial

Outcome Measures

Primary Outcomes (1)

  • Self-report of not having smoked for the past 7 days

    Self-report of not having smoked for the past 7 days at 6th month after initial intervention

    At 6th month after the initial intervention

Secondary Outcomes (6)

  • Self-report of not having smoked for the past 7 days

    At 12th month after the initial intervention

  • Self-report of not having smoked for 7 days at 6th month after initial intervention, as validated by exhaled carbon monoxide test

    At 6th month after the initial intervention

  • Self-report of not having smoked for 7 days at 6th month after initial intervention, as validated by urinary cotinine test

    At 6th month after the initial intervention

  • Self-report of not having smoked for 7 days at 12th month after initial intervention, as validated by urinary cotinine test

    At 12th month after the initial intervention

  • Forward progression on stages of readiness in smoking cessation

    At 6th month after the initial intervention

  • +1 more secondary outcomes

Study Arms (2)

Acceptance and commitment therapy

EXPERIMENTAL

All participants are given a brief educational talk on encouraging quitting smoking, a self-help leaflet on smoking cessation and an additional 10-session face-to-face ACT on a weekly basis.

Behavioral: Acceptance and commitment therapy

Control

PLACEBO COMPARATOR

All participants are given a brief educational talk on encouraging quitting smoking , a self-help leaflet on smoking cessation and 10-sessions of face-to-face social support on a weekly basis.

Other: Control

Interventions

Acceptance and commitment therapyBEHAVIORAL

All participants are given a brief educational talk on encouraging quitting smoking (about 5 mins) and a self-help leaflet on smoking cessation. Ten sessions of face-to-face ACT individually will additionally be provided by trained therapists on a weekly basis. Each session will last about 20-30 minutes. The therapy is guided by ACT smoking cessation protocols based on relevant literature (Gifford et al 2004, 2011; Bricker, 2010).

Also known as: ACT
Acceptance and commitment therapy
ControlOTHER

All participants are given a brief educational talk on encouraging quitting smoking (about 5 mins) and a self-help leaflet on smoking cessation. Ten sessions of face-to-face Social Support will additionally be provided on a weekly basis. Each session will last about 5 minutes.

Control

Eligibility Criteria

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

You may qualify if:

  • aged 18 years or above;
  • diagnosed with schizophrenia;
  • referred by medical doctors;
  • currently smoking, i.e. have at least one cigarette per day in the past month,
  • willing to take part in a face-to-face individual intervention program in changing smoking behaviors such as smoking cessation, reduction of cigarette consumed, or the relief of withdrawal symptoms.
  • able to communicate in Cantonese.

You may not qualify if:

  • disorientation, developmental disabilities, and/or organic conditions that will inhibit his/her understanding and participation in the therapeutic process,
  • diagnosis of alcohol or drug dependence in the preceding year of recruitment or,
  • medication regime revised in the last 3 months or,
  • current participation in another smoking cessation program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon

Hong Kong, Hong Kong

RECRUITING

Related Publications (6)

  • Twohig MP, Crosby JM. Acceptance and commitment therapy as a treatment for problematic internet pornography viewing. Behav Ther. 2010 Sep;41(3):285-95. doi: 10.1016/j.beth.2009.06.002. Epub 2010 Jan 28.

    PMID: 20569778BACKGROUND

  • Flaxman PE, Blackledge JT, Bond FW. Acceptance and commitment therapy: Distinctive features. London & New York: Routledge; 2002.

    BACKGROUND

  • Bricker JB, Mann SL, Marek PM, Liu J, Peterson AV. Telephone-delivered Acceptance and Commitment Therapy for adult smoking cessation: a feasibility study. Nicotine Tob Res. 2010 Apr;12(4):454-8. doi: 10.1093/ntr/ntq002. Epub 2010 Feb 8.

    PMID: 20142417BACKGROUND

  • Gifford EV, Kohlenberg BS, Hayes SC, Pierson HM, Piasecki MP, Antonuccio DO, Palm KM. Does acceptance and relationship focused behavior therapy contribute to bupropion outcomes? A randomized controlled trial of functional analytic psychotherapy and acceptance and commitment therapy for smoking cessation. Behav Ther. 2011 Dec;42(4):700-15. doi: 10.1016/j.beth.2011.03.002. Epub 2011 May 25.

    PMID: 22035998BACKGROUND

  • Gifford EV, Kohlenberg BS, Hayes SC, Antonuccio DO, Piasecki MM, Rasmussen-Hall ML, et al. Acceptance based treatment for smoking cessation. Behav Ther. 2004;35(4):689-705. doi: 10.1016/S0005-7894(04)80015-7. Epub 2006 Mar 3.

    BACKGROUND

  • 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

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

Central Study Contacts

Yim Wah Mak, PhD

CONTACT

852-27666421yw.mak@polyu.edu.hk

Sin Sum Hui, Bachelor

CONTACT

27666119sshui@polyu.edu.hk

Study Design

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

Study Record Dates

First Submitted

March 18, 2016

First Posted

August 17, 2017

Study Start

July 1, 2014

Primary Completion

December 1, 2017

Study Completion

June 1, 2018

Last Updated

August 17, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)