Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07441928

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Smoking Cessation Behavior Health Behavior Mental Disorders Schizophenia Disorder Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: at the 6-month post-intervention follow-up

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

  2. Chinese version of the Brief Psychiatric Rating Scale

    Time frame: at the 6-month post-intervention follow-up

    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.

  3. functional neuroimaging (fMRI)

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

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

Secondary outcomes

  1. Level of nicotine dependence

    Time frame: at the 6-month follow-up

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

  2. Nicotine Withdrawal symptoms

    Time frame: at the 6-month post intervention follow-up

    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).

  3. Effects of ACT on psychological flexibility, specifical for smoking cessation

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

    will be measured by smoking-related experiential avoidance using the Avoidance and Inflexibility Scale (AIS) (Farris et al., 2015).

  4. Experiential Avoidance

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

    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)

  5. current recorded medications

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

    Types of current taken medications

Study contacts

Contact information is provided by the study sponsor or research team.

Xuelin Zhang, PhD

CONTACT

[email protected]

15307195670

Yim Wah Mak

CONTACT

[email protected]

852-2766 6421

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

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

Registry information

Official study 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

Acronym: ACT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.