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RecruitingNCT07441928

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

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
90 (estimated)
Sponsor
The Hong Kong Polytechnic University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
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.

Timeline

Start date
2023-03-01
Primary completion
2026-04-30
Completion
2026-04-30
First posted
2026-03-02
Last updated
2026-03-02

Locations

5 sites across 1 country: Hong Kong

Source: ClinicalTrials.gov record NCT07441928. Inclusion in this directory is not an endorsement.