About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
220 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Mindfulness-based Treatment to Prevent Smoking Relapse

Clinicaltrials.gov identifier NCT03930329

Recruitment Status Recruiting

First Posted April 29, 2019

Last update posted September 3, 2020

Study Description

Brief 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.

  • Condition or Disease:Smoking Cessation
  • Intervention/Treatment: Behavioral: MBRP group
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 40 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Prevention
  • Official Title: Mindfulness-based Treatment to Prevent Smoking Relapse: a Pilot Randomized Controlled Study
  • Actual Study Start Date: July 2019
  • Estimated Primary Completion Date: March 2021
  • Estimated Study Completion Date: March 2021
Arms and interventions
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
Outcome Measures
  • Primary Outcome Measures: 1. the rate of retention [ Time Frame: recruitment and thoughout the 8-week program ]
    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
  • 2. rate of recruitment [ Time Frame: from recruitment to the start of the 8-week program ]
    As a pilot study to test the feasibility of the future RCT, the primary outcomes will include the rates of recruitment and retention.
  • Secondary Outcome Measures: 1. 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 ]
    reported abstinence from smoking during the last seven days, which will be confirmed with an expired carbon monoxide level of <6 ppm
  • 2. 9-item Patient Health Questionnaire (PHQ-9) [ Time Frame: assessed at baseline (before class 1) and immediately after the eighth MBRP class ]
    validated instrument for depressive symptoms
  • 3. 7-item Generalized Anxiety Disorder Questionnaire (GAD-7) [ Time Frame: assessed at baseline (before class 1) and immediately after the eighth MBRP class ]
    validated instrument for anxiety symptoms
  • 4. the Alcohol Use Identification Test (AUDIT) [ Time Frame: assessed at baseline (before class 1) and immediately after the eighth MBRP class ]
    validated instrument for alcohol use
  • 5. 10-item Perceived Stress Scale [ Time Frame: assessed at baseline (before class 1) and immediately after the eighth MBRP class ]
    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
  • 6. 20-item Positive Affect and Negative Affect Scale [ Time Frame: assessed at baseline (before class 1) and immediately after the eighth MBRP class ]
    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
  • 7. Minnesota Nicotine Withdrawal Scale [ Time Frame: assessed at baseline (before class 1) and immediately after the eighth MBRP class ]
    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
  • 8. Five-Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: assessed at baseline (before class 1) and immediately after the eighth MBRP class ]
    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
  • 9. Brief questionnaire of smoking urges [ Time Frame: assessed at baseline (before class 1) and immediately after the eighth MBRP class ]
    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
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

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

Contacts and Locations
Contacts

Contact: Kam Pui Lee, MSc 2252 8562 lkp032@cuhk.edu.hk

Locations

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

Sponsors and Collaborators

Chinese University of Hong Kong

Tung Wah Group for Hospital Integrated Centre

More Information
  • Responsible Party: Chinese University of Hong Kong
  • ClinicalTrials.gov Identifier: NCT03930329 History of Changes
  • Other Study ID Numbers: NTEC-2019-smoke
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: September 3, 2020
  • Last Verified: September 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Plan Description: will make available on request of investigators
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Recurrence