Effects of Smoking on Network Connectivity in Patients With Schizophrenia Symptoms in Scz Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Hong Kong Polytechnic University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.)
Trial design
Design model
Parallel
Treatments tested in this trial
Acceptance and Commitment Therapy (ACT-SC)
Other interventionAcceptance 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 interventionUsual 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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: 30 current smokersExperimental treatment 2 interventions
Group B: 60 non-smokersNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Biochemically validated self-reported 7-day point prevalence tobacco abstinence
an exhaled CO level of \< 6 ppm (Javis et al., 1987).
Time frame
at the 6-month post-intervention follow-up2
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.
Time frame
at the 6-month post-intervention follow-up3
functional neuroimaging (fMRI)
Neural activities will be assessed by function at University Research Facility in Behavioural and Systems Neuroscience (UBSN) at PolyU.
Time frame
in three time points [at baseline (T1: before the intervention), post-intervention (T2), and 6-month follow-up (T3)]Secondary outcomes
1
Level of nicotine dependence
will be measured using the Fagerstrom Test for Nicotine Dependence (Heatherton et al., 1991).
Time frame
at the 6-month follow-up2
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).
Time frame
at the 6-month post intervention follow-up3
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).
Time frame
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)
Time frame
in three time points [at baseline (T1: before the intervention), post-intervention (T2), and 6-month follow-up (T3)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The Hong Kong Polytechnic University
Lead sponsor
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
Source ClinicalTrials.gov