Effects of Smoking on Network Connectivity in Patients With Schizophrenia Symptoms in Scz Patients (ACT)

Using Functional Magnetic Resonance Imaging (fMRI) to Assess the Effects of Acceptance and Commitment Therapy for Smoking Cessation and Reduction of Psychotic Symptoms in Patients With Schizophrenia

The prevalence of smoking among people with schizophrenia (SCZ) is substantially higher at 54% to 90% (McClave et al., 2010). About half of all deaths amongst people with scz are attributed to smoking-related diseases and cancer involving the lung, the cardiovascular system, and the liver (Kely et al., 2011; WHO, 2019). Acceptance and commitment therapy (ACT) is effective for treating psychotic symptoms and addictive behaviours. In a local randomised controlled trial comparing individual ACT to social support for smoking cessation in adult scz smokers, the self-reported quit rates in ACT group were higher than in the social support group (6 months: 12.3% vs. 7.7%, p=0.56 ; 12 months: 10.8% vs. 7.7%, p=0.76; Mak, Loke, and Leung, 2021). In this study, functional neuroimaging (fMRI) will be combined with symptoms assessment in order to ascertain whether group-based ACT is effective in modifying the brain's responses in general and specifically to tobacco craving cues and resting-state functional connectivity in three time points (pre-, post-intervention, and 6-month follow-up) among people with schizophrenia.

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation; Schizophenia Disorder
• Intervention / Treatment: Other: Acceptance and Commitment Therapy (ACT-SC); Other: 5A model (Ask, Assess, Advice, Assist & Arrange) smoking cessation intervention (5A-SC)

Detailed Description

Functional neuroimaging (fMRI) will be combined with symptoms assessment in order to ascertain whether Acceptance and Commitment Therapy (ACT) is effective in modifying the brain's responses in general and specifically to tobacco craving cues and resting-state functional connectivity in three time points (pre-, post-intervention, and 6-month follow-up) among people with schizophrenia.

60 Participants who are currently smoking but not undergoing any smoking cessation or similar programme will be assigned to one of the two smoking cessation intervention programmes either by (i) using Acceptance and Commitment Therapy (ACT-SC) group or (ii) 5A model (Ask, Assess, Advice, Assist & Arrange) smoking cessation intervention (5A-SC) group; 30 participants who are not smokers will be assigned to a non-smoking control group (NS-CG).

Study design: Randomized controlled trial Group assignment: Parallel Disease group: Mental and behavioural disorders Key conditions under study: schizophrenia; nicotine dependence

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yim Wah Mak; Phone Number: 852-2766 6421; Email: yw.mak@polyu.edu.hk
• Study Contact Backup: Name: Xuelin Zhang, PhD; Phone Number: 15307195670; Email: xuelzhang@polyu.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Lok Hong Integrated Community Centre for Mental Wellness, Tung Wah Group of Hospitals
    • Contact: Robert Lau
  • Hong Kong, Hong Kong
    • Recruiting
    • Mental Health and Development, Christian Family Service Centre
    • Contact: Petsy SY Chow; Phone Number: 3521 1611; Email: wellness@cfsc.org.hk
  • Hong Kong, Hong Kong
    • Recruiting
    • Out-patient Clinic (Psy), Pamela Youde Nethersole Eastern Hospital
    • Contact: Chris KH Ngai
  • Hong Kong, Hong Kong
    • Recruiting
    • The Mental Health Association of Hong Kong
    • Contact: Benson KK Chan
  • Hong Kong, Hong Kong
    • Recruiting
    • The Society of Rehabilitation and Crime Prevention
    • Contact: Willy WL Choi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Individuals who have been diagnosed with schizophrenia or schizoaffective disorder and after at least one-year followup;
• currently taking anti-psychotic medications for ≥ 3 months with good compliance;
• aged 18 years or above;
• able to communicate in Cantonese

Exclusion Criteria:

• Have any other current or past psychotic disorders;
• with fleeting or actual suicidal/self-harm ideations, or acting-out behavior in the past;
• with a known history of violence/aggression and a forensic history
• Categorized with special care or intensive care (e.g., arson, battery, physical assault, rape, murder, etc.)
• Have a lifetime history of substance abuse and/or are currently receiving treatment for substance abuse (e.g., opioids, cocaine, marijuana, or stimulants);
• With alcohol consumption exceeding 25 standard drinks/week for men and 20 standard drinks/week for women over the last 6 months;
• Have received a diagnosis of alcohol or drug dependence in the year preceding recruitment;
• Are pregnant, breast-feeding, or planning a pregnancy for the duration of the study;
• Have a history or current diagnosis of attention-deficit hyperactivity disorder (ADHD);
• Have a history of epilepsy or a seizure disorder;
• Experience disorientation, have developmental disabilities, and/or an organic mental disorder;
• fMRI-related exclusion criteria promulgated by University Research Facility in Behavioural and Systems Neuroscience (UBSN), PolyU

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 30 current smokers; will be randomized to: either (i) using Acceptance and Commitment Therapy (ACT-SC) group or (ii) 5A model (Ask, Assess, Advice, Assist & Arrange) smoking cessation intervention (5A-SC) group	Other: Acceptance and Commitment Therapy (ACT-SC); Acceptance and Commitment Smoking Cessation (ACT-SC) Group: Participants in the ACT group will be given a group-based face-to-face ACT intervention, with up to six individuals per group. Participants will attend a total of eight sessions, twice per week, with each session lasting 1.5 hours. The intervention focuses on helping participants (i) to increase acceptance of thoughts and feelings related to cigarette cravings and withdrawal symptoms; (ii) to clarify and engage with life values; and (iii) to build up patterns of committed values identified even in the presence of cravings and/or withdrawal symptoms. Participants will also be encouraged to practice mindfulness and ACT skills in between sessions. The protocol is listed in the appendix 2: ACT intervention protocol.; Other: 5A model (Ask, Assess, Advice, Assist & Arrange) smoking cessation intervention (5A-SC); Usual Care Smoking Cessation (5A-SC) Group: Participants in the 5A-SC group also receive an intervention of the same duration and be given the same amount of attention as the intervention group - namely, a smoking cessation intervention based on the '5A' and '5R' models proposed by the World Health Organization. The '5A' model emphasizes five steps: Asking about tobacco use, Advising smokers to quit, Assessing their willingness to quit, Assisting in quitting, and Arranging for follow-up (Whitlock et al., 2002). The model is used in our government-funded Youth Quitline, operated by the School of Nursing, PolyU. (Please refer to the appendix 3: 5A smoking cessation protocol. The intervention will be conducted by a research assistant (RA2) trained in the 5A approach.
No Intervention: 60 non-smokers; will be assigned to a non-smoking control group (NS-CG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemically validated self-reported 7-day point prevalence tobacco abstinence	an exhaled CO level of < 6 ppm (Javis et al., 1987).	at the 6-month post-intervention follow-up
Chinese version of the Brief Psychiatric Rating Scale	The Brief Psychiatric Rating Scale (BPRS) (Overall & et al, 1988) is one of the rating scales widely used by health professionals to assess common symptoms of schizophrenia and other mental disorders. The scaling categories include positive symptoms, negative symptoms, affects and activations, allowing a more diverse understanding of a client's mental state.	at the 6-month post-intervention follow-up
functional neuroimaging (fMRI)	Neural activities will be assessed by function at University Research Facility in Behavioural and Systems Neuroscience (UBSN) at PolyU.	in three time points [at baseline (T1: before the intervention), post-intervention (T2), and 6-month follow-up (T3)]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of nicotine dependence	will be measured using the Fagerstrom Test for Nicotine Dependence (Heatherton et al., 1991).	at the 6-month follow-up
Nicotine Withdrawal symptoms	Nicotine withdrawal causes temporary, intense cravings and physical symptoms-including irritability, anxiety, poor concentration, insomnia, and increased appetite-that typically peak in the first week and subside within 2-4 weeks. The desire to smoke will be assessed by a single statement "I have a desire to smoke" helps monitor these cravings (Tiffany and Drobes, 1991).	at the 6-month post intervention follow-up
Effects of ACT on psychological flexibility, specifical for smoking cessation	will be measured by smoking-related experiential avoidance using the Avoidance and Inflexibility Scale (AIS) (Farris et al., 2015).	in three time points [at baseline (T1: before the intervention), post-intervention (T2), and 6-month follow-up (T3)]
Experiential Avoidance	The Brief Experiential Avoidance Questionnaire (BEAQ) is a 15-item self-report tool used to measure experiential avoidance-the tendency to escape or avoid uncomfortable thoughts, emotions, and sensations. It acts as a measure of the inverse of psychological flexibility, with higher BEAQ scores indicating lower flexibility and greater rigidity in emotional regulation. The Chinese version of BEAQ will be used (Cao, Mak, Li & Leung, 2021)	in three time points [at baseline (T1: before the intervention), post-intervention (T2), and 6-month follow-up (T3)
current recorded medications	Types of current taken medications	in three time points [at baseline (T1: before the intervention), post-intervention (T2), and 6-month follow-up (T3)]

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Pamela Youde Nethersole Eastern Hospital; Castle Peak Hospital; Tung Wah Group of Hospitals; The Mental Health Association of Hong Kong; Christian Family Service Centre; Kwai Chung Hospital
• Investigators: Principal Investigator: Yim Wah Mak, School of Nursing, The Hong Kong Polytechnic University

Publications and helpful links

General Publications

• Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.
• Jarvis MJ, Tunstall-Pedoe H, Feyerabend C, Vesey C, Saloojee Y. Comparison of tests used to distinguish smokers from nonsmokers. Am J Public Health. 1987 Nov;77(11):1435-8. doi: 10.2105/ajph.77.11.1435.
• Raskin A. Discussion: recent developments in ascertainment and scaling of the BPRS. Psychopharmacol Bull. 1988;24(1):122-4. No abstract available.
• Mak YW, Loke AY, Leung DYP. Acceptance and Commitment Therapy versus Social Support for Smoking Cessation for People with Schizophrenia: A Randomised Controlled Trial. J Clin Med. 2021 Sep 22;10(19):4304. doi: 10.3390/jcm10194304.
• Tiffany ST, Drobes DJ. The development and initial validation of a questionnaire on smoking urges. Br J Addict. 1991 Nov;86(11):1467-76. doi: 10.1111/j.1360-0443.1991.tb01732.x.
• Farris SG, Zvolensky MJ, DiBello AM, Schmidt NB. Validation of the Avoidance and Inflexibility Scale (AIS) among treatment-seeking smokers. Psychol Assess. 2015 Jun;27(2):467-477. doi: 10.1037/pas0000059. Epub 2015 Feb 2.
• Cao, H., Mak, Y. W., Li, H. Y., & Leung, D. Y. (2021). Chinese validation of the Brief Experiential Avoidance Questionnaire (BEAQ) in college students. Journal of Contextual Behavioral Science, 19, 79-85.
• Gross JJ, Thompson RA. Emotion regulation: Conceptual foundations. In Gross JJ, Ed. Handbook of emotion regulation. New York: The Guilford Press; 2007:3-24
• Shiffman SM, Jarvik ME. Smoking withdrawal symptoms in two weeks of abstinence. Psychopharmacology (Berl). 1976 Oct 20;50(1):35-9. doi: 10.1007/BF00634151.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: psychotic symptoms; smoking cessation; Schizophrenia (SCZ); Functional neuroimaging (fMRI); Acceptance and Commitment therapy (ACT)
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavior; Health Behavior; Schizophrenia; Smoking Cessation; Investigative Techniques; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Behavioral Disciplines and Activities; Reproductive Techniques, Assisted; Reproductive Techniques; Mental Health Services; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Insemination, Artificial; Insemination; Counseling; Insemination, Artificial, Heterologous; corticosteroid hormone-induced factor
• Other Study ID Numbers: HSEARS20220621005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No