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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03930329
Other study ID # NTEC-2019-smoke
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 24, 2019
Est. completion date July 31, 2021

Study information

Verified date August 2021
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date July 31, 2021
Est. primary completion date July 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - age =18 years - self-reported smokers - can speak and read Cantonese and Chinese - willing to participate in at least 7 of the 8 sessions of the MBRP program Exclusion Criteria: - pregnancy (they will have different motivations for quitting smoking) - significant physical illness or severe cognitive impairment that prevents communication, such as blindness or severe hearing loss, because mindfulness exercise instructions are given verbally and reading materials are given out after each class - history of psychotic disorders or symptoms, because MBRP is not confirmed safe or effective in this group of patients - suicidal tendency as detected by PHQ-9 (see below) - we will not exclude participants with mood disorders for the reasons stated in the introduction, but participants with drug changes for their mood disorders in the last 3 months will be excluded (ethics approval and informed consent will be obtained for assessing patients' medical records, CMS of the hospital authority or e-health, to confirm drug information) - active illicit drug use and - past mindfulness course or practices in the previous 12 months

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
MBRP group
same as arm description

Locations

Country Name City State
Hong Kong Tung Wah Group of Hospitals, Integrated Centre on Smoking Cessation, Tuen Mun Centre Hong Kong

Sponsors (2)

Lead Sponsor Collaborator
Chinese University of Hong Kong Tung Wah Group for Hospital Integrated Centre

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 recruitment and thoughout the 8-week program
Primary 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. from recruitment to the start of the 8-week program
Secondary 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 assessed at baseline (before class 1) and immediately after the eighth MBRP class
Secondary 9-item Patient Health Questionnaire (PHQ-9) validated instrument for depressive symptoms assessed at baseline (before class 1) and immediately after the eighth MBRP class
Secondary 7-item Generalized Anxiety Disorder Questionnaire (GAD-7) validated instrument for anxiety symptoms assessed at baseline (before class 1) and immediately after the eighth MBRP class
Secondary the Alcohol Use Identification Test (AUDIT) validated instrument for alcohol use assessed at baseline (before class 1) and immediately after the eighth MBRP class
Secondary 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 assessed at baseline (before class 1) and immediately after the eighth MBRP class
Secondary 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 assessed at baseline (before class 1) and immediately after the eighth MBRP class
Secondary 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 assessed at baseline (before class 1) and immediately after the eighth MBRP class
Secondary 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 assessed at baseline (before class 1) and immediately after the eighth MBRP class
Secondary 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 assessed at baseline (before class 1) and immediately after the eighth MBRP class
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