Schizophenia Disorder, Smoking Cessation
Conditions
Keywords
Schizophrenia (SCZ), smoking cessation, Functional neuroimaging (fMRI), Acceptance and Commitment therapy (ACT), psychotic symptoms
Brief 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, 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.
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
Interventions
OTHERAcceptance and Commitment Therapy (ACT-SC)
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.
OTHER5A model (Ask, Assess, Advice, Assist & Arrange) smoking cessation intervention (5A-SC)
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.
Sponsors
The Hong Kong Polytechnic University
Christian Family Service Centre
The Mental Health Association of Hong Kong
Tung Wah Group of Hospitals
Kwai Chung Hospital
Castle Peak Hospital
Pamela Youde Nethersole Eastern Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Single-blinded
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemically validated self-reported 7-day point prevalence tobacco abstinence | at the 6-month post-intervention follow-up | an exhaled CO level of \< 6 ppm (Javis et al., 1987). |
| Chinese version of the Brief Psychiatric Rating Scale | 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. |
| functional neuroimaging (fMRI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Level of nicotine dependence | at the 6-month follow-up | will be measured using the Fagerstrom Test for Nicotine Dependence (Heatherton et al., 1991). |
| Nicotine Withdrawal symptoms | 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). |
| Effects of ACT on psychological flexibility, specifical for smoking cessation | 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). |
| Experiential Avoidance | 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) |
| current recorded medications | in three time points [at baseline (T1: before the intervention), post-intervention (T2), and 6-month follow-up (T3)] | Types of current taken medications |
Countries
Hong Kong
Contacts
CONTACTYim Wah Mak
CONTACTXuelin Zhang, PhD
PRINCIPAL_INVESTIGATORYim Wah Mak
School of Nursing, The Hong Kong Polytechnic University
Outcome results
None listed