Group Acceptance and Commitment Therapy to reduce smoking and change brain connectivity in people with schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized parallel-group study will enroll smokers with schizophrenia who are not currently in a cessation program and randomize 60 participants to group-based Acceptance and Commitment Therapy (ACT-SC) or a 5A smoking cessation intervention (5A-SC), with an additional 30 non-smoking controls. Functional MRI will be performed at three time points (pre-intervention, post-intervention, and 6-month follow-up) to measure brain responses to tobacco craving cues and resting-state functional connectivity alongside symptom and smoking outcome measures. The trial combines behavioral outcomes (quit rates, smoking behavior, psychotic symptoms) with neuroimaging to link clinical effects to changes in brain networks. Local community mental health centers and a hospital outpatient clinic in Hong Kong will deliver the interventions and imaging.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

Study contacts

• Principal investigator: Yim Wah Mak — School of Nursing, The Hong Kong Polytechnic University
• Study coordinator: Yim Wah Mak
• Email: yw.mak@polyu.edu.hk
• Phone: 852-2766 6421

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Quitting Matters: a smoking quit program for people living with HIV

  This 6-month program will test whether a tailored smartphone app plus nicotine patches and gum helps people living with HIV quit smoking better than a standard quit app.

  Recruiting Wake Forest University Health Sciences · Winston-Salem, North Carolina · NCT06883097

• Smoky Futures: Danish Adolescent Nicotine Use over Time

  This observational cohort follows Danish youths ages 15–25 to see how cigarette, e-cigarette, and other nicotine use begin, change, and affect health and education over several years.

  Recruiting University of Southern Denmark · Copenhagen · NCT07910331

• Nicotine Orodispersible Tablet to Relieve Cravings in Smokers

  A nicotine mint orodispersible tablet is tested vs placebo to see if it quickly eases the urge to smoke in adult cigarette smokers.

  Recruiting Phase 2 Kenvue Brands LLC · Mississauga, Ontario · NCT07893158

• Optimizing when weekly chatbot reminders go out to people using a chatbot for quitting smoking

  This study tests whether sending weekly reminders at different times helps people stay engaged with a chatbot smoking-cessation service.

  Recruiting The University of Hong Kong · Hong Kong · NCT07826884

• NMDA and Sigma-1 combination therapy for smoking cessation with AXS-05

  This phase 3 trial tests whether AXS-05 can help adults quit smoking better than placebo or bupropion.

  Recruiting at 28 sites Phase 3 Axsome Therapeutics, Inc. · Phoenix, Arizona and 27 other locations · NCT07766655

• AI-assisted interactive case-based training to improve smoking cessation counseling by medical interns

  This study tests whether AI-powered interactive case-based training helps medical interns provide better smoking cessation counseling.

  Recruiting Assiut University · Asyut, Assuit · NCT07650721

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.