Mindfulness-based Treatment to Prevent Smoking Relapse

Smoking Cessation Clinical Trial

Official title:

Mindfulness-based Treatment to Prevent Smoking Relapse: a Pilot Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03930329
• Other study ID #: NTEC-2019-smoke
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Recurrence
• Smoking Cessation

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