Background: Smoking causes a variety of health problems and causes burden to healthcare systems. Even when support is provided, local data suggest that around 50% of biochemically confirmed quitters resume smoking within 6 months of participating in a smoking cessation program. Mindfulness-based intervention is a promising option because accumulating evidence from randomized controlled trials support its use among smokers. Our team aims to determine if mindfulness-based interventions can prevent relapse in smokers who recently quit smoking. A pilot trial is needed to determine the feasibility of recruitment, randomisation and acceptability of the intervention in these patients Method: Forty participants, who just quitted smoking, will be randomised in a 1:1 ratio to the 8week mindfulness-based relapse prevention (MBRP) program and to usual care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
25
same as arm description
Tung Wah Group of Hospitals, Integrated Centre on Smoking Cessation, Tuen Mun Centre
Hong Kong, Hong Kong
the rate of retention
As a pilot study to test the feasibility of the future RCT, the primary outcomes will include the rates of recruitment and retention. The amount of homework completed will be self-reported using a homework diary
Time frame: recruitment and thoughout the 8-week program
rate of recruitment
As a pilot study to test the feasibility of the future RCT, the primary outcomes will include the rates of recruitment and retention.
Time frame: from recruitment to the start of the 8-week program
reported abstinence from smoking during the last seven days, which will be confirmed with an expired carbon monoxide level of <6 ppm
reported abstinence from smoking during the last seven days, which will be confirmed with an expired carbon monoxide level of \<6 ppm
Time frame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
9-item Patient Health Questionnaire (PHQ-9)
validated instrument for depressive symptoms
Time frame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
7-item Generalized Anxiety Disorder Questionnaire (GAD-7)
validated instrument for anxiety symptoms
Time frame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
the Alcohol Use Identification Test (AUDIT)
validated instrument for alcohol use
Time frame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
10-item Perceived Stress Scale
validated instrument for stress level; there are two factors: (i) perceived helplessness and (ii) perceived efficacy; each subscales' score can be calculated by adding up scored from individual questions; Perceived helplessness subscale score: 0-24 (higher is worse); perceived efficacy subscale score 0-16 (higher the better) total score calculation: reverse scoring for questions in 'self-efficacy' sub-scale, total score can be calculated by adding all the scores together; Theoretical rage: 0 to 40; The higher the score, the higher the perceived stress
Time frame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
20-item Positive Affect and Negative Affect Scale
validated instrument for positive and negative affect; 10 item for positive items and 10 for negative items; score range from 10-50 for both items. For total positive score, a higher score indicates more of a positive affect. For the total negative score, a lower score indicates less of a negative affect
Time frame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
Minnesota Nicotine Withdrawal Scale
no subscale; total score is the sum of the score of individual item; possible score: 0-36; the higher the score, the more severe the withdrawal symptoms
Time frame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
Five-Facet Mindfulness Questionnaire (FFMQ)
validated instrument to assess the level of mindfulness; 5 subscale; each subscale score is calucated by adding score from individual items; the protocol had included reverse scoring for item 3, 5, 8, 10, 12, 13, 14, 16, 17, 18, 22, 23, 25, 28, 30, 34, 35, 38, 39. Subscale score: observing (8-40), describe (8-40), act with awareness (8-40), nonjudge (8-40), nonreact (7-35); the higher the score, the higher the degree of mindfulness in each subscale
Time frame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
Brief questionnaire of smoking urges
subscale 1 - intention/desire to smoke; subscale 2 - relief of negative affect \& urgent desire to smoke; the score of each subscale is calculated by adding the score from individual items; possible scores for each subscale = 5-35; the higher the score, the higher the smoking urge
Time frame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
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