Mindfulness-based Treatment to Prevent Smoking Relapse

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

MBRP group

About this trial

This is an interventional prevention trial for Smoking Cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MBRP group

usual care

Arm Description

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

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)

Outcomes

Primary Outcome Measures

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

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.

Secondary Outcome Measures

reported abstinence from smoking during the last seven days, which will be confirmed with an expired carbon monoxide level of <6 ppm

9-item Patient Health Questionnaire (PHQ-9)

validated instrument for depressive symptoms

7-item Generalized Anxiety Disorder Questionnaire (GAD-7)

validated instrument for anxiety symptoms

the Alcohol Use Identification Test (AUDIT)

validated instrument for alcohol use

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

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

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

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

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

Full Information

NCT ID

NCT03930329

First Posted

April 16, 2019

Last Updated

August 29, 2021

Sponsor

Chinese University of Hong Kong

Collaborators

Tung Wah Group for Hospital Integrated Centre

1. Study Identification

Unique Protocol Identification Number

NCT03930329

Brief Title

Mindfulness-based Treatment to Prevent Smoking Relapse

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

July 24, 2019 (Actual)

Primary Completion Date

July 31, 2021 (Actual)

Study Completion Date

July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese University of Hong Kong

Collaborators

Tung Wah Group for Hospital Integrated Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Smoking Cessation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MBRP group

Arm Type

Experimental

Arm Description

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

Arm Title

usual care

Arm Type

No Intervention

Arm Description

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)

Intervention Type

Behavioral

Intervention Name(s)

MBRP group

Intervention Description

same as arm description

Primary Outcome Measure Information:

Title

the rate of retention

Description

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

Title

rate of recruitment

Description

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

Secondary Outcome Measure Information:

Title

reported abstinence from smoking during the last seven days, which will be confirmed with an expired carbon monoxide level of <6 ppm

Description

reported abstinence from smoking during the last seven days, which will be confirmed with an expired carbon monoxide level of <6 ppm

Time Frame