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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 5
- 主要终点
- Biochemically validated self-reported 7-day point prevalence tobacco abstinence
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single-blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
30 current smokers
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
干预措施: Acceptance and Commitment Therapy (ACT-SC) (Other)
30 current smokers
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
干预措施: 5A model (Ask, Assess, Advice, Assist & Arrange) smoking cessation intervention (5A-SC) (Other)
60 non-smokers
will be assigned to a non-smoking control group (NS-CG)
结局指标
主要结局
Biochemically validated self-reported 7-day point prevalence tobacco abstinence
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- Level of nicotine dependence(at the 6-month follow-up)
- Nicotine Withdrawal symptoms(at the 6-month post intervention follow-up)
- 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)])
- Experiential Avoidance(in three time points [at baseline (T1: before the intervention), post-intervention (T2), and 6-month follow-up (T3))
- current recorded medications(in three time points [at baseline (T1: before the intervention), post-intervention (T2), and 6-month follow-up (T3)])
研究者
Yim Wah MAK, Ph.D
Associate Professor
The Hong Kong Polytechnic University