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

NCT ID: NCT03253445

Last Updated: 2017-08-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2018-06-30

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.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Acceptance and commitment therapy

Intervention Type: BEHAVIORAL

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).

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.

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

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.

Interventions

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).

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Other Intervention Names

ACT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Yim Wah Mak

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

YW Mak, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Nursing, The Hong Kong Polytechnic University

AY Loke, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Nursing, The Hong Kong Polytechnic University

Locations

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

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Yim Wah Mak, PhD

Role: CONTACT

yw.mak@polyu.edu.hk

852-27666421

Sin Sum Hui, Bachelor

Role: CONTACT

sshui@polyu.edu.hk

27666119

Facility Contacts

Yim Wah Mak, PhD

Role: primary

yw.mak@polyu.edu.hk

27666421 ext. 6421

Alice Yuen Loke, PhD

Role: backup

alice.yuen.loke@polyu.edu.hk

27666386 ext. 6386

References

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.

Reference Type: BACKGROUND

PMID: 20569778 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 20142417 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22035998 (View on PubMed)

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.

Reference Type: 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.

Reference Type: DERIVED

PMID: 35420700 (View on PubMed)

Other Identifiers

ACTSP01032016

Identifier Type: -

Identifier Source: org_study_id