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| Name | Class |
|---|---|
| Christian Family Service Centre | OTHER |
| The Mental Health Association of Hong Kong | OTHER |
| Tung Wah Group of Hospitals | OTHER |
| Kwai Chung Hospital |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 current smokers | Experimental | will be randomized to: either (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 non-smokers | No Intervention | will be assigned to a non-smoking control group (NS-CG) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemically validated self-reported 7-day point prevalence tobacco abstinence | an exhaled CO level of < 6 ppm (Javis et al., 1987). | at the 6-month post-intervention follow-up |
| 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. | at the 6-month post-intervention follow-up |
| functional neuroimaging (fMRI) | Neural activities will be assessed by function at University Research Facility in Behavioural and Systems Neuroscience (UBSN) at PolyU. | in three time points [at baseline (T1: before the intervention), post-intervention (T2), and 6-month follow-up (T3)] |
| Measure | Description | Time Frame |
|---|---|---|
| Level of nicotine dependence | will be measured using the Fagerstrom Test for Nicotine Dependence (Heatherton et al., 1991). | at the 6-month follow-up |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yim Wah Mak | Contact | 852-2766 6421 | yw.mak@polyu.edu.hk | |
| Xuelin Zhang, PhD | Contact | 15307195670 | xuelzhang@polyu.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Yim Wah Mak | School of Nursing, The Hong Kong Polytechnic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lok Hong Integrated Community Centre for Mental Wellness, Tung Wah Group of Hospitals | Recruiting | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34640321 | Background | Mak YW, Loke AY, Leung DYP. Acceptance and Commitment Therapy versus Social Support for Smoking Cessation for People with Schizophrenia: A Randomised Controlled Trial. J Clin Med. 2021 Sep 22;10(19):4304. doi: 10.3390/jcm10194304. | |
| 3661797 | Background | Jarvis MJ, Tunstall-Pedoe H, Feyerabend C, Vesey C, Saloojee Y. Comparison of tests used to distinguish smokers from nonsmokers. Am J Public Health. 1987 Nov;77(11):1435-8. doi: 10.2105/ajph.77.11.1435. |
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| OTHER |
| Castle Peak Hospital | OTHER_GOV |
| Pamela Youde Nethersole Eastern Hospital | OTHER |
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).
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Single-blinded
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| 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. |
|
| at the 6-month post intervention follow-up |
| 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). | in three time points [at baseline (T1: before the intervention), post-intervention (T2), and 6-month follow-up (T3)] |
| 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) | in three time points [at baseline (T1: before the intervention), post-intervention (T2), and 6-month follow-up (T3) |
| current recorded medications | Types of current taken medications | in three time points [at baseline (T1: before the intervention), post-intervention (T2), and 6-month follow-up (T3)] |
| Mental Health and Development, Christian Family Service Centre | Recruiting | Hong Kong | Hong Kong |
|
| Out-patient Clinic (Psy), Pamela Youde Nethersole Eastern Hospital | Recruiting | Hong Kong | Hong Kong |
|
| The Mental Health Association of Hong Kong | Recruiting | Hong Kong | Hong Kong |
|
| The Society of Rehabilitation and Crime Prevention | Recruiting | Hong Kong | Hong Kong |
|
| 1932883 | Background | Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x. |
| 1777741 | Background | Tiffany ST, Drobes DJ. The development and initial validation of a questionnaire on smoking urges. Br J Addict. 1991 Nov;86(11):1467-76. doi: 10.1111/j.1360-0443.1991.tb01732.x. |
| 25642937 | Background | Farris SG, Zvolensky MJ, DiBello AM, Schmidt NB. Validation of the Avoidance and Inflexibility Scale (AIS) among treatment-seeking smokers. Psychol Assess. 2015 Jun;27(2):467-477. doi: 10.1037/pas0000059. Epub 2015 Feb 2. |
| Background | Cao, H., Mak, Y. W., Li, H. Y., & Leung, D. Y. (2021). Chinese validation of the Brief Experiential Avoidance Questionnaire (BEAQ) in college students. Journal of Contextual Behavioral Science, 19, 79-85. |
| Background | Gross JJ, Thompson RA. Emotion regulation: Conceptual foundations. In Gross JJ, Ed. Handbook of emotion regulation. New York: The Guilford Press; 2007:3-24 |
| 827760 | Background | Shiffman SM, Jarvik ME. Smoking withdrawal symptoms in two weeks of abstinence. Psychopharmacology (Berl). 1976 Oct 20;50(1):35-9. doi: 10.1007/BF00634151. |
| 3387516 | Background | Raskin A. Discussion: recent developments in ascertainment and scaling of the BPRS. Psychopharmacol Bull. 1988;24(1):122-4. No abstract available. |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C422209 | corticosteroid hormone-induced factor |
| D003376 | Counseling |
| D007316 | Insemination, Artificial, Heterologous |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D007315 | Insemination, Artificial |
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D007314 | Insemination |
| D012098 | Reproduction |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
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