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Individual Acceptance and Commitment Therapy (ACT) for Smoking Cessation for Schizophrenic Patients

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ClinicalTrials.gov Identifier: NCT03253445
Recruitment Status : Unknown
Verified August 2017 by Dr. Yim Wah Mak, The Hong Kong Polytechnic University.
Recruitment status was:  Recruiting
First Posted : August 17, 2017
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Yim Wah Mak, The Hong Kong Polytechnic University

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

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Acceptance and commitment therapy Other: Control Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Individual, Acceptance and Commitment Therapy (ACT) in Smoking Cessation for People With Schizophrenia: a Randomized Controlled Trial
Study Start Date : July 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acceptance and commitment therapy
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
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).
Other Name: ACT

Placebo Comparator: Control
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
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.




Primary Outcome Measures :
  1. Self-report of not having smoked for the past 7 days [ Time Frame: At 6th month after the initial intervention ]
    Self-report of not having smoked for the past 7 days at 6th month after initial intervention


Secondary Outcome Measures :
  1. Self-report of not having smoked for the past 7 days [ Time Frame: At 12th month after the initial intervention ]
    Self-report of not having smoked for the past 7 days at 12th month after initial intervention

  2. Self-report of not having smoked for 7 days at 6th month after initial intervention, as validated by exhaled carbon monoxide test [ Time Frame: At 6th month after the initial intervention ]
    Using exhaled carbon monoxide test to validate self-report of not having smoked for 7 days at 6th month after initial intervention

  3. Self-report of not having smoked for 7 days at 6th month after initial intervention, as validated by urinary cotinine test [ Time Frame: At 6th month after the initial intervention ]
    Using urinary cotinine test to validate self-report of not having smoked for 7 days at 6th month after initial intervention

  4. Self-report of not having smoked for 7 days at 12th month after initial intervention, as validated by urinary cotinine test [ Time Frame: At 12th month after the initial intervention ]
    Using urinary cotinine test to validate self-report of not having smoked for 7 days at 12th month after initial intervention

  5. Forward progression on stages of readiness in smoking cessation [ Time Frame: At 6th month after the initial intervention ]
    Self-report of forward progression on stages of readiness in smoking cessation. Prochaska's Transtheoretical Model of behavior change is used to assess the stages of readiness in smoking cessation

  6. Increasing psychological flexibility [ Time Frame: At 6th month and 12th month after the initial intervention ]
    Acceptance and Action Questionnaire - II (AAQ-II) is used to assess the psychological flexibility of the participants



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. aged 18 years or above;
  2. diagnosed with schizophrenia;
  3. referred by medical doctors;
  4. currently smoking, i.e. have at least one cigarette per day in the past month,
  5. 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.
  6. able to communicate in Cantonese.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253445


Contacts
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Contact: Yim Wah Mak, PhD 852-27666421 yw.mak@polyu.edu.hk
Contact: Sin Sum Hui, Bachelor 27666119 sshui@polyu.edu.hk

Locations
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Hong Kong
School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon Recruiting
Hong Kong, Hong Kong
Contact: Yim Wah Mak, PhD    27666421 ext 6421    yw.mak@polyu.edu.hk   
Contact: Alice Yuen Loke, PhD    27666386 ext 6386    alice.yuen.loke@polyu.edu.hk   
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
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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:
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Responsible Party: Dr. Yim Wah Mak, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03253445     History of Changes
Other Study ID Numbers: ACTSP01032016
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 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
ACT
schizophrenic patients
hostel setting
randomised controlled trial