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AzTrials

Smoking CessationACTNCT07441928

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

A study testing Acceptance and Commitment Therapy (ACT-SC) and 5A model (Ask, Assess, Advice, Assist & Arrange) smoking cessation intervention (5A-SC) in people with Smoking Cessation and Schizophenia Disorder, run by The Hong Kong Polytechnic University at 5 sites in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Smoking Cessation, Schizophenia Disorder
What is being tested?
Acceptance and Commitment Therapy (ACT-SC) and 5A model (Ask, Assess, Advice, Assist & Arrange) smoking cessation intervention (5A-SC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
5 sitesHong Kong
Study dates
1 Mar 2023to 30 Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
Show all 12Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yim Wah Mak contact

852-2766 6421

yw.mak@polyu.edu.hk

Xuelin Zhang, PhD contact

15307195670

xuelzhang@polyu.edu.hk

5 sites in 1 country

Hong Kong5 sites, 5 recruiting

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

    Hong Kong

    Robert Lau

    Recruiting

  • Mental Health and Development, Christian Family Service Centre

    Hong Kong

    Petsy SY Chow, 3521 1611, wellness@cfsc.org.hk

    Recruiting

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

    Hong Kong

    Chris KH Ngai

    Recruiting

  • The Mental Health Association of Hong Kong

    Hong Kong

    Benson KK Chan

    Recruiting

  • The Society of Rehabilitation and Crime Prevention

    Hong Kong

    Willy WL Choi

    Recruiting

Other trials in Hong Kong

About this study

Official title: 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.

Read the 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

Being tested
Acceptance and Commitment Therapy (ACT-SC), 5A model (Ask, Assess, Advice, Assist & Arrange) smoking cessation intervention (5A-SC)
Keywords
Schizophrenia (SCZ), smoking cessation, Functional neuroimaging (fMRI), Acceptance and Commitment therapy (ACT), psychotic symptoms
Medical subject headings
Smoking Cessation, Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT07441928
Study groupRoleWhat they receive
30 current smokersExperimentalwill 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
Receives: Other: Acceptance and Commitment Therapy (ACT-SC); Other: 5A model (Ask, Assess, Advice, Assist & Arrange) smoking cessation intervention (5A-SC)
60 non-smokersNo interventionwill be assigned to a non-smoking control group (NS-CG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biochemically validated self-reported 7-day point prevalence tobacco abstinence

    an exhaled CO level of < 6 ppm (Javis et al., 1987).

    Measured: at the 6-month post-intervention follow-up

  2. 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.

    Measured: at the 6-month post-intervention follow-up

  3. functional neuroimaging (fMRI)

    Neural activities will be assessed by function at University Research Facility in Behavioural and Systems Neuroscience (UBSN) at PolyU.

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

Secondary outcomes (5)

  1. Level of nicotine dependence

    will be measured using the Fagerstrom Test for Nicotine Dependence (Heatherton et al., 1991).

    Measured: at the 6-month follow-up

  2. 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).

    Measured: at the 6-month post intervention follow-up

  3. 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).

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

  4. 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)

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

  5. current recorded medications

    Types of current taken medications

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2026
  2. Study start1 Mar 2023
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completion30 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07441928
Sponsor's protocol ID
HSEARS20220621005
Acronym
ACT
Status last verified
Feb 2026
First submitted
23 Feb 2026
Last updated
2 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34640321

  • 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.

    PubMed 3661797

  • 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.

    PubMed 1932883

  • 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.

    PubMed 1777741

  • 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.

    PubMed 25642937

  • 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.

    PubMed 827760

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

    PubMed 3387516

Questions about this trial

What is this clinical trial studying?

A study testing Acceptance and Commitment Therapy (ACT-SC) and 5A model (Ask, Assess, Advice, Assist & Arrange) smoking cessation intervention (5A-SC) in people with Smoking Cessation and Schizophenia Disorder, run by The Hong Kong Polytechnic University at 5 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yim Wah Mak (852-2766 6421, yw.mak@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemically validated self-reported 7-day point prevalence tobacco abstinence (time frame: at the 6-month post-intervention follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07441928, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.

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