<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03253445</url>
  </required_header>
  <id_info>
    <org_study_id>ACTSP01032016</org_study_id>
    <nct_id>NCT03253445</nct_id>
  </id_info>
  <brief_title>Individual Acceptance and Commitment Therapy (ACT) for Smoking Cessation for Schizophrenic Patients</brief_title>
  <official_title>Individual, Acceptance and Commitment Therapy (ACT) in Smoking Cessation for People With Schizophrenia: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hong Kong Polytechnic University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy of using Acceptance and commitment&#xD;
      therapy for smoking cessation for schizophrenic patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Amongst people with mental disorders, the prevalence of smoking has been reported&#xD;
      to be the highest among people with schizophrenia, ranging from 54%-90%. It is more than two&#xD;
      to three times (20%-30%) of the general population. The co-occurrence of schizophrenia and&#xD;
      smoking will lead to a higher chance of smoking-related diseases such as cardiovascular&#xD;
      disease, liver diseases and reduced life expectancy. Currently, there is a large gap in&#xD;
      knowledge regarding smoking cessation in people with schizophrenia; there has been few&#xD;
      studies examining non-pharmacological interventions in smoking cessation on people with&#xD;
      schizophrenia. Acceptance and commitment therapy (ACT) for mental health disorders has found&#xD;
      that it has in general positive outcomes for the clients; improvements were consistently&#xD;
      found in a number of studies. ACT is more encouraging compared to traditional methods of&#xD;
      smoking cessation, where the individual is seen to be at fault for the habit. To date, no&#xD;
      randomized trial has been conducted to compare the effects of ACT in smoking cessation among&#xD;
      people with schizophrenia.&#xD;
&#xD;
      Objective: To evaluate the efficacy of Acceptance and Commitment Therapy (ACT) in enhancing&#xD;
      smoking cessation among people with schizophrenia living in the community.&#xD;
&#xD;
      Design: This is a randomised controlled trial. Individual, face to face, assessor-blinded&#xD;
      with assessments will be conducted before intervention, after intervention, and at the 6th&#xD;
      and 12th month after the initial session of ACT intervention.&#xD;
&#xD;
      Participants and setting: 160 individuals aged 18 years or older, currently smoking but not&#xD;
      undergoing any smoking cessation or similar programme, who were diagnosed with schizophrenia&#xD;
      and were referred to 4 community-based mental health rehabilitation settings by medical&#xD;
      doctors will be included in this trial.&#xD;
&#xD;
      Using the Six Core Processes in Intervention (Flaxman, Blackledge &amp; Bond, 2010) Acceptance By&#xD;
      acceptance, ACT does not mean by the traditional sense of &quot;letting go&quot;, &quot;admitting faith&#xD;
      passively&quot;, or &quot;do something after acknowledging the facts&quot;. Since psychological avoidance&#xD;
      toward distress, which can be unfavorable thoughts, emotions, will inevitably push individual&#xD;
      to evade such experiences, ACT attacks the problem by accepting the psychological distress as&#xD;
      it is, without distorting, interpreting or re-interpreting it through verbal constructs.&#xD;
&#xD;
      Defusion Patients frequently, if not inevitably, fall into the trap of fusing their thoughts&#xD;
      and appraisals with their self-concept. They are often so identified with the internal&#xD;
      dialogues that whenever a thought of judging themselves arise, they treat them as a valid&#xD;
      statement of evaluation on themselves. Cognitive defusion aims at creating a space between&#xD;
      the thought and its relation with the individual, with the effect that the words, thoughts,&#xD;
      and emotions are down-valued as a reference rather than a valid description of who we are.&#xD;
&#xD;
      Self as context Our sense of self is often derived from our experienced thoughts, emotions,&#xD;
      memories and physical sensations. This is called the self-as-content and is a readily&#xD;
      accessible self-concept most of us would refer to. By addressing the above experience,&#xD;
      especially the more frequent ones, we draw the conclusion that we are the person defined by&#xD;
      them. On the contrary, ACT adopts the notion of self-as-context and defines the self as that&#xD;
      stable, ever-present part of you that notices the transient thoughts, emotions, memories and&#xD;
      sensations that enter in and out of awareness. When the self-as-context is embraced, the self&#xD;
      is no longer defined as the various thoughts, feelings, and sensations, but as the person who&#xD;
      is having or noticing those experiences. Although ACT makes no attempt to discern which one&#xD;
      is a better representation of the self, it does appreciate self-as-context as a way to&#xD;
      examine the distance between those internal experiences and the self.&#xD;
&#xD;
      Contact with the Present Moment Making a closer contact with the present moment is the key to&#xD;
      seeing how effectively or ineffectively what we are behaving in the moment, and that places&#xD;
      us in a better position to change our behaviors as well as a higher motivation to do so.&#xD;
      However, thoughts are always pulling us away from the present moment and we are either in the&#xD;
      past or future. In fact, thoughts are about anything and everything except now.&#xD;
&#xD;
      Values Values are perhaps the most powerful reinforcers in driving us to our goal and at the&#xD;
      same time a valuable asset for individuals who are trying to live what they expect from life.&#xD;
      Instead of swamping oneself in numerous problems, issues, regrets, and longings, values&#xD;
      provide a powerful drive for patients to act according to what they want to become.&#xD;
      Therapist, on the other hand, have a consistent measure as to the way the patients have to&#xD;
      live up to their own expectations. Still more, therapist and patients are to endeavor&#xD;
      collaboratively in working out the qualities in realizing patients' values.&#xD;
&#xD;
      Committed Action If value is the train, commitment is the fuel that drives the person&#xD;
      forward. Value, together with commitment, is a non-binding guideline that points to the way&#xD;
      an individual can act. Therapist, on the other hand, is supposed to reinforce and encourage&#xD;
      behaviors that are consistent with the values. Any behaviors inconsistent with the values are&#xD;
      to be accepted as they are in a non-judgmental attitude, and the patient is encouraged to&#xD;
      choose again in accordance to his values. Commitment is not only viewed as a promise but also&#xD;
      actions that realize what one believes and upholds.&#xD;
&#xD;
      Competency of therapist:&#xD;
&#xD;
      The following are extracted from the core competencies self rating form posted at the website&#xD;
      of Association for Contextual Behavioral Science (Luoma, n.d.).&#xD;
&#xD;
      Basic competency in ACT The therapist is able to take heed of the patient's schizophrenic&#xD;
      background and introduce the concepts and skills of ACT in a simple language that is&#xD;
      compatible with the level of cognition and intelligence of the patient.&#xD;
&#xD;
      The therapist helps the patient to realize his beliefs, thoughts, desires, fears and worries&#xD;
      with smoking cessation.&#xD;
&#xD;
      The therapist assists the patient in addressing in-depth his/her motivations and values&#xD;
      regarding smoking cessation.&#xD;
&#xD;
      The therapist is capable of leading the patient to apprehend the futility of the attempts to&#xD;
      control the cravings and accept the urges as it is without necessarily yielding to them.&#xD;
&#xD;
      By guiding the patient to see the hopelessness of controlling craving, the therapist is able&#xD;
      to guide the patient to the ultimate solution-doing nothing, i.e., the mindfulness strategy&#xD;
      of observing the cravings without the need to do anything.&#xD;
&#xD;
      The therapist assists the patient to bring about actions in executing his/her values in a&#xD;
      practical manner amidst even the most unfavorable circumstances as perceived by the patient.&#xD;
&#xD;
      The therapist is able to master the six core processes of ACT and uses them flexibly by the&#xD;
      flow of the therapy and the need of the patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-report of not having smoked for the past 7 days</measure>
    <time_frame>At 6th month after the initial intervention</time_frame>
    <description>Self-report of not having smoked for the past 7 days at 6th month after initial intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-report of not having smoked for the past 7 days</measure>
    <time_frame>At 12th month after the initial intervention</time_frame>
    <description>Self-report of not having smoked for the past 7 days at 12th month after initial intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-report of not having smoked for 7 days at 6th month after initial intervention, as validated by exhaled carbon monoxide test</measure>
    <time_frame>At 6th month after the initial intervention</time_frame>
    <description>Using exhaled carbon monoxide test to validate self-report of not having smoked for 7 days at 6th month after initial intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-report of not having smoked for 7 days at 6th month after initial intervention, as validated by urinary cotinine test</measure>
    <time_frame>At 6th month after the initial intervention</time_frame>
    <description>Using urinary cotinine test to validate self-report of not having smoked for 7 days at 6th month after initial intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-report of not having smoked for 7 days at 12th month after initial intervention, as validated by urinary cotinine test</measure>
    <time_frame>At 12th month after the initial intervention</time_frame>
    <description>Using urinary cotinine test to validate self-report of not having smoked for 7 days at 12th month after initial intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forward progression on stages of readiness in smoking cessation</measure>
    <time_frame>At 6th month after the initial intervention</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increasing psychological flexibility</measure>
    <time_frame>At 6th month and 12th month after the initial intervention</time_frame>
    <description>Acceptance and Action Questionnaire - II (AAQ-II) is used to assess the psychological flexibility of the participants</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Acceptance and commitment therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Acceptance and commitment therapy</intervention_name>
    <description>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).</description>
    <arm_group_label>Acceptance and commitment therapy</arm_group_label>
    <other_name>ACT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>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.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. aged 18 years or above;&#xD;
&#xD;
          2. diagnosed with schizophrenia;&#xD;
&#xD;
          3. referred by medical doctors;&#xD;
&#xD;
          4. currently smoking, i.e. have at least one cigarette per day in the past month,&#xD;
&#xD;
          5. willing to take part in a face-to-face individual intervention program in changing&#xD;
             smoking behaviors such as smoking cessation, reduction of cigarette consumed, or the&#xD;
             relief of withdrawal symptoms.&#xD;
&#xD;
          6. able to communicate in Cantonese.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. disorientation, developmental disabilities, and/or organic conditions that will&#xD;
             inhibit his/her understanding and participation in the therapeutic process,&#xD;
&#xD;
          2. diagnosis of alcohol or drug dependence in the preceding year of recruitment or,&#xD;
&#xD;
          3. medication regime revised in the last 3 months or,&#xD;
&#xD;
          4. current participation in another smoking cessation program.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>YW Mak, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>School of Nursing, The Hong Kong Polytechnic University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>AY Loke, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>School of Nursing, The Hong Kong Polytechnic University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yim Wah Mak, PhD</last_name>
    <phone>852-27666421</phone>
    <email>yw.mak@polyu.edu.hk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sin Sum Hui, Bachelor</last_name>
    <phone>27666119</phone>
    <email>sshui@polyu.edu.hk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yim Wah Mak, PhD</last_name>
      <phone>27666421</phone>
      <phone_ext>6421</phone_ext>
      <email>yw.mak@polyu.edu.hk</email>
    </contact>
    <contact_backup>
      <last_name>Alice Yuen Loke, PhD</last_name>
      <phone>27666386</phone>
      <phone_ext>6386</phone_ext>
      <email>alice.yuen.loke@polyu.edu.hk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>20569778</PMID>
  </reference>
  <reference>
    <citation>Flaxman PE, Blackledge JT, Bond FW. Acceptance and commitment therapy: Distinctive features. London &amp; New York: Routledge; 2002.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>20142417</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22035998</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>March 18, 2016</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
    <investigator_full_name>Dr. Yim Wah Mak</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>smoking cessation</keyword>
  <keyword>acceptance and commitment therapy</keyword>
  <keyword>ACT</keyword>
  <keyword>schizophrenic patients</keyword>
  <keyword>hostel setting</keyword>
  <keyword>randomised controlled trial</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03253445
org study id: ACTSP01032016
nct id: NCT03253445
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the efficacy of using Acceptance and commitment
      therapy for smoking cessation for schizophrenic patients.
Background: Amongst people with mental disorders, the prevalence of smoking has been reported
      to be the highest among people with schizophrenia, ranging from 54%-90%. It is more than two
      to three times (20%-30%) of the general population. The co-occurrence of schizophrenia and
      smoking will lead to a higher chance of smoking-related diseases such as cardiovascular
      disease, liver diseases and reduced life expectancy. Currently, there is a large gap in
      knowledge regarding smoking cessation in people with schizophrenia; there has been few
      studies examining non-pharmacological interventions in smoking cessation on people with
      schizophrenia. Acceptance and commitment therapy (ACT) for mental health disorders has found
      that it has in general positive outcomes for the clients; improvements were consistently
      found in a number of studies. ACT is more encouraging compared to traditional methods of
      smoking cessation, where the individual is seen to be at fault for the habit. To date, no
      randomized trial has been conducted to compare the effects of ACT in smoking cessation among
      people with schizophrenia.

      Objective: To evaluate the efficacy of Acceptance and Commitment Therapy (ACT) in enhancing
      smoking cessation among people with schizophrenia living in the community.

      Design: This is a randomised controlled trial. Individual, face to face, assessor-blinded
      with assessments will be conducted before intervention, after intervention, and at the 6th
      and 12th month after the initial session of ACT intervention.

      Participants and setting: 160 individuals aged 18 years or older, currently smoking but not
      undergoing any smoking cessation or similar programme, who were diagnosed with schizophrenia
      and were referred to 4 community-based mental health rehabilitation settings by medical
      doctors will be included in this trial.

      Using the Six Core Processes in Intervention (Flaxman, Blackledge & Bond, 2010) Acceptance By
      acceptance, ACT does not mean by the traditional sense of "letting go", "admitting faith
      passively", or "do something after acknowledging the facts". Since psychological avoidance
      toward distress, which can be unfavorable thoughts, emotions, will inevitably push individual
      to evade such experiences, ACT attacks the problem by accepting the psychological distress as
      it is, without distorting, interpreting or re-interpreting it through verbal constructs.

      Defusion Patients frequently, if not inevitably, fall into the trap of fusing their thoughts
      and appraisals with their self-concept. They are often so identified with the internal
      dialogues that whenever a thought of judging themselves arise, they treat them as a valid
      statement of evaluation on themselves. Cognitive defusion aims at creating a space between
      the thought and its relation with the individual, with the effect that the words, thoughts,
      and emotions are down-valued as a reference rather than a valid description of who we are.

      Self as context Our sense of self is often derived from our experienced thoughts, emotions,
      memories and physical sensations. This is called the self-as-content and is a readily
      accessible self-concept most of us would refer to. By addressing the above experience,
      especially the more frequent ones, we draw the conclusion that we are the person defined by
      them. On the contrary, ACT adopts the notion of self-as-context and defines the self as that
      stable, ever-present part of you that notices the transient thoughts, emotions, memories and
      sensations that enter in and out of awareness. When the self-as-context is embraced, the self
      is no longer defined as the various thoughts, feelings, and sensations, but as the person who
      is having or noticing those experiences. Although ACT makes no attempt to discern which one
      is a better representation of the self, it does appreciate self-as-context as a way to
      examine the distance between those internal experiences and the self.

      Contact with the Present Moment Making a closer contact with the present moment is the key to
      seeing how effectively or ineffectively what we are behaving in the moment, and that places
      us in a better position to change our behaviors as well as a higher motivation to do so.
      However, thoughts are always pulling us away from the present moment and we are either in the
      past or future. In fact, thoughts are about anything and everything except now.

      Values Values are perhaps the most powerful reinforcers in driving us to our goal and at the
      same time a valuable asset for individuals who are trying to live what they expect from life.
      Instead of swamping oneself in numerous problems, issues, regrets, and longings, values
      provide a powerful drive for patients to act according to what they want to become.
      Therapist, on the other hand, have a consistent measure as to the way the patients have to
      live up to their own expectations. Still more, therapist and patients are to endeavor
      collaboratively in working out the qualities in realizing patients' values.

      Committed Action If value is the train, commitment is the fuel that drives the person
      forward. Value, together with commitment, is a non-binding guideline that points to the way
      an individual can act. Therapist, on the other hand, is supposed to reinforce and encourage
      behaviors that are consistent with the values. Any behaviors inconsistent with the values are
      to be accepted as they are in a non-judgmental attitude, and the patient is encouraged to
      choose again in accordance to his values. Commitment is not only viewed as a promise but also
      actions that realize what one believes and upholds.

      Competency of therapist:

      The following are extracted from the core competencies self rating form posted at the website
      of Association for Contextual Behavioral Science (Luoma, n.d.).

      Basic competency in ACT The therapist is able to take heed of the patient's schizophrenic
      background and introduce the concepts and skills of ACT in a simple language that is
      compatible with the level of cognition and intelligence of the patient.

      The therapist helps the patient to realize his beliefs, thoughts, desires, fears and worries
      with smoking cessation.

      The therapist assists the patient in addressing in-depth his/her motivations and values
      regarding smoking cessation.

      The therapist is capable of leading the patient to apprehend the futility of the attempts to
      control the cravings and accept the urges as it is without necessarily yielding to them.

      By guiding the patient to see the hopelessness of controlling craving, the therapist is able
      to guide the patient to the ultimate solution-doing nothing, i.e., the mindfulness strategy
      of observing the cravings without the need to do anything.

      The therapist assists the patient to bring about actions in executing his/her values in a
      practical manner amidst even the most unfavorable circumstances as perceived by the patient.

      The therapist is able to master the six core processes of ACT and uses them flexibly by the
      flow of the therapy and the need of the patient.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Outcomes Assessor)
measure: Self-report of not having smoked for the past 7 days
time frame: At 6th month after the initial intervention
description: Self-report of not having smoked for the past 7 days at 6th month after initial intervention
measure: Self-report of not having smoked for the past 7 days
time frame: At 12th month after the initial intervention
description: Self-report of not having smoked for the past 7 days at 12th month after initial intervention
measure: 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
description: Using exhaled carbon monoxide test to validate self-report of not having smoked for 7 days at 6th month after initial intervention
measure: 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
description: Using urinary cotinine test to validate self-report of not having smoked for 7 days at 6th month after initial intervention
measure: 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
description: Using urinary cotinine test to validate self-report of not having smoked for 7 days at 12th month after initial intervention
measure: Forward progression on stages of readiness in smoking cessation
time frame: At 6th month after the initial intervention
description: 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
measure: Increasing psychological flexibility
time frame: At 6th month and 12th month after the initial intervention
description: Acceptance and Action Questionnaire - II (AAQ-II) is used to assess the psychological flexibility of the participants
arm group label: Acceptance and commitment therapy
arm group type: Experimental
description: 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.
arm group label: Control
arm group type: Placebo Comparator
description: 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.
intervention type: Behavioral
intervention name: Acceptance and commitment therapy
description: 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).
arm group label: Acceptance and commitment therapy
other name: ACT
intervention type: Other
intervention name: Control
description: 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.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: YW Mak, PhD
role: Principal Investigator
affiliation: School of Nursing, The Hong Kong Polytechnic University
last name: AY Loke, PhD
role: Principal Investigator
affiliation: School of Nursing, The Hong Kong Polytechnic University
last name: Yim Wah Mak, PhD
phone: 852-27666421
email: yw.mak@polyu.edu.hk
last name: Sin Sum Hui, Bachelor
phone: 27666119
email: sshui@polyu.edu.hk
facility: 
status: Recruiting
contact: 
contact backup: 
country: Hong Kong
citation: 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: 20569778
citation: Flaxman PE, Blackledge JT, Bond FW. Acceptance and commitment therapy: Distinctive features. London & New York: Routledge; 2002.
citation: 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: 20142417
citation: 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: 22035998
citation: 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.
responsible party type: Principal Investigator
investigator affiliation: The Hong Kong Polytechnic University
investigator full name: Dr. Yim Wah Mak
investigator title: Assistant Professor
sharing ipd: No