Effects of Smoking on Network Connectivity in Patients With Schizophrenia Symptoms in Scz Patients

Official title

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

Overview

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

• Other Acceptance 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 (ii
• Other 5A 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 (Whitloc

Primary outcome measures

• Biochemically validated self-reported 7-day point prevalence tobacco abstinence [Time frame: at the 6-month post-intervention follow-up]
• Chinese version of the Brief Psychiatric Rating Scale [Time frame: at the 6-month post-intervention follow-up]
• functional neuroimaging (fMRI) [Time frame: in three time points [at baseline (T1: before the intervention), post-intervention (T2), and 6-month follow-up (T3)]]

Secondary outcome measures (5)

• Level of nicotine dependence [Time frame: at the 6-month follow-up]
• Nicotine Withdrawal symptoms [Time frame: at the 6-month post intervention follow-up]
• Effects of ACT on psychological flexibility, specifical for smoking cessation [Time frame: in three time points [at baseline (T1: before the intervention), post-intervention (T2), and 6-month follow-up (T3)]]
• Experiential Avoidance [Time frame: in three time points [at baseline (T1: before the intervention), post-intervention (T2), and 6-month follow-up (T3)]
• current recorded medications [Time frame: in three time points [at baseline (T1: before the intervention), post-intervention (T2), and 6-month follow-up (T3)]]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Hong Kong · 5 centers

• Lok Hong Integrated Community Centre for Mental Wellness, Tung Wah Group of Hospitals — Hong Kong
• Mental Health and Development, Christian Family Service Centre — Hong Kong
• Out-patient Clinic (Psy), Pamela Youde Nethersole Eastern Hospital — Hong Kong
• The Mental Health Association of Hong Kong — Hong Kong
• The Society of Rehabilitation and Crime Prevention — Hong Kong

Publications

• 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. PMID 34640321
• 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. PMID 3661797
• 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. PMID 1932883
• 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. PMID 1777741
• 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. PMID 25642937
• 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.
• Gross JJ, Thompson RA. Emotion regulation: Conceptual foundations. In Gross JJ, Ed. Handbook of emotion regulation. New York: The Guilford Press; 2007:3-24
• 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. PMID 827760

Identifiers

NCT: NCT07441928 · HSEARS20220621005

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗