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

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

This trial tests whether group Acceptance and Commitment Therapy helps people with schizophrenia who smoke to quit and changes brain responses to tobacco cues.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Hong Kong Polytechnic University (other)
• Locations: 5 sites (Hong Kong and 4 other locations)
• Trial ID: NCT07441928 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (18+) with a diagnosis of schizophrenia or schizoaffective disorder (≥1 year follow-up), on stable antipsychotic medication for ≥3 months with good adherence, who currently smoke and can communicate in Cantonese are ideal candidates.

Not a fit: People with other current or past psychotic disorders, recent suicidal or violent behavior, forensic history, current or recent substance dependence, heavy alcohol use, non-smokers, or those unable to attend Hong Kong sites or communicate in Cantonese are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the intervention could increase quit rates among people with schizophrenia, reduce smoking-related health risks, and identify brain-network changes that support targeted therapies.

How similar studies have performed: Prior small trials indicate ACT can help psychotic symptoms and addictive behaviors and a local individual-ACT trial showed numerically higher quit rates, but group ACT combined with fMRI for smoking in schizophrenia remains relatively novel.

Eligibility criteria

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 this trial is running

Hong Kong and 4 other locations

• 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

Conditions: Smoking Cessation, Schizophenia Disorder, Schizophrenia, smoking cessation, Functional neuroimaging, Acceptance and Commitment therapy, psychotic symptoms