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

NCT07441928 | Recruiting DMC

• 1 other identifier: HSEARS20220621005
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Smoking Cessation; Schizophenia Disorder

Keywords

Schizophrenia (SCZ); smoking cessation; Functional neuroimaging (fMRI); Acceptance and Commitment therapy (ACT); psychotic symptoms

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Level of nicotine dependence

  at the 6-month follow-up

• Nicotine Withdrawal symptoms

  at the 6-month post intervention follow-up

• Effects of ACT on psychological flexibility, specifical for smoking cessation

  in three time points [at baseline (T1: before the intervention), post-intervention (T2), and 6-month follow-up (T3)]

• Experiential Avoidance

  in three time points [at baseline (T1: before the intervention), post-intervention (T2), and 6-month follow-up (T3)

• current recorded medications

  in three time points [at baseline (T1: before the intervention), post-intervention (T2), and 6-month follow-up (T3)]

Study Arms (2)

30 current smokers

EXPERIMENTAL

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); Other: 5A model (Ask, Assess, Advice, Assist & Arrange) smoking cessation intervention (5A-SC)

60 non-smokers

NO INTERVENTION

will be assigned to a non-smoking control group (NS-CG)

Interventions

Acceptance and Commitment Therapy (ACT-SC) OTHER

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.

30 current smokers

5A model (Ask, Assess, Advice, Assist & Arrange) smoking cessation intervention (5A-SC) OTHER

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.

30 current smokers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Christian Family Service Centre: collaborator
• The Mental Health Association of Hong Kong: collaborator
• Tung Wah Group of Hospitals: collaborator
• Kwai Chung Hospital: collaborator
• Castle Peak Hospital: collaborator
• Pamela Youde Nethersole Eastern Hospital: collaborator

Study Sites (5)

Lok Hong Integrated Community Centre for Mental Wellness, Tung Wah Group of Hospitals

Hong Kong, Hong Kong

RECRUITING

Mental Health and Development, Christian Family Service Centre

Hong Kong, Hong Kong

RECRUITING

Out-patient Clinic (Psy), Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong

RECRUITING

The Mental Health Association of Hong Kong

Hong Kong, Hong Kong

RECRUITING

The Society of Rehabilitation and Crime Prevention

Hong Kong, Hong Kong

RECRUITING

Related Publications (9)

• 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.

  PMID: 34640321 BACKGROUND

• 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.

  PMID: 3661797 BACKGROUND

• 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.

  PMID: 1932883 BACKGROUND

• 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.

  PMID: 1777741 BACKGROUND

• 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.

  PMID: 25642937 BACKGROUND

• 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.

  BACKGROUND

• Gross JJ, Thompson RA. Emotion regulation: Conceptual foundations. In Gross JJ, Ed. Handbook of emotion regulation. New York: The Guilford Press; 2007:3-24

  BACKGROUND

• 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.

  PMID: 827760 BACKGROUND

• Raskin A. Discussion: recent developments in ascertainment and scaling of the BPRS. Psychopharmacol Bull. 1988;24(1):122-4. No abstract available.

  PMID: 3387516 BACKGROUND

MeSH Terms

Conditions

Smoking Cessation; Schizophrenia

Interventions

corticosteroid hormone-induced factor; Counseling; Insemination, Artificial, Heterologous

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Yim Wah Mak

  School of Nursing, The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yim Wah Mak

CONTACT

852-2766 6421; yw.mak@polyu.edu.hk

Xuelin Zhang, PhD

CONTACT

15307195670; xuelzhang@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 30 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; 60 participants who are not smokers will be assigned to a non-smoking control group (NS-CG).

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 2, 2026
• Study Start: March 1, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (5)