Clinical trial NCT03253445: Individual Acceptance and Commitment Therapy (ACT) for Smoking Cessation for Schizophrenic Patients
Official title: Individual, Acceptance and Commitment Therapy (ACT) in Smoking Cessation for People With Schizophrenia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking Cessation
Keywords: smoking cessation
acceptance and commitment therapy
ACT
schizophrenic patients
hostel setting
randomised controlled trial
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Self-report of not having smoked for the past 7 days
timeFrame: At 6th month after the initial intervention
Secondary outcomes:
measure: Self-report of not having smoked for the past 7 days
timeFrame: At 12th month after the 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
timeFrame: At 6th month after the initial intervention
measure: Self-report of not having smoked for 7 days at 6th month after initial intervention, as validated by urinary cotinine test
timeFrame: At 6th month after the initial intervention
measure: Self-report of not having smoked for 7 days at 12th month after initial intervention, as validated by urinary cotinine test
timeFrame: At 12th month after the initial intervention
measure: Forward progression on stages of readiness in smoking cessation
timeFrame: At 6th month after the initial intervention
measure: Increasing psychological flexibility
timeFrame: At 6th month and 12th month after the initial intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon
Study officials:
affiliation: School of Nursing, The Hong Kong Polytechnic University
name: YW Mak, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Nursing, The Hong Kong Polytechnic University
name: AY Loke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.