Mindfulness-based Treatment to Prevent Smoking Relapse

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

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 Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: MBRP group

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Tung Wah Group of Hospitals, Integrated Centre on Smoking Cessation, Tuen Mun Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MBRP group; The mindfulness-based relapse prevention program consists of eight weekly 2-hour sessions. It combines mindfulness with evidence-based cognitive behavioural techniques that help participants to recognize internal and external triggers of their substance abuse, including smoking. Each session consists of mindful practices with cognitive exercises. The standardized treatment manual was published	Behavioral: MBRP group; same as arm description
No Intervention: usual care; All participants in this trial will receive usual care, which consists of 8-12 weeks of counselling and drug treatment to help smokers quit. Data from the centre shows that approximately 50% of smokers are successfully abstinent from smoking at end of the program, as confirmed by the carbon monoxide breath test. This trial will only recruit those who successfully quitted smoking. During this 8-12 week program, written information about relapse prevention is given, including information for maintaining healthy lifestyles (e.g. diet/sleep/exercise/emotional control). Participants will receive follow-up phone interviews by trained smoking cessation counsellors at end of the program (week 8-12)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
the Alcohol Use Identification Test (AUDIT)	validated instrument for alcohol use	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	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	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	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	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	assessed at baseline (before class 1) and immediately after the eighth MBRP class

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: Tung Wah Group for Hospital Integrated Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2019
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (Actual): April 29, 2019

Study Record Updates

• Last Update Posted (Actual): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 29, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: NTEC-2019-smoke

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: will make available on request of investigators

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No