Mindfulness-based Treatment to Prevent Smoking Relapse

NCT03930329 | Completed

• 1 other identifier: NTEC-2019-smoke
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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)

  assessed at baseline (before class 1) and immediately after the eighth MBRP class

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

  assessed at baseline (before class 1) and immediately after the eighth MBRP class

• the Alcohol Use Identification Test (AUDIT)

  assessed at baseline (before class 1) and immediately after the eighth MBRP class

• 10-item Perceived Stress Scale

  assessed at baseline (before class 1) and immediately after the eighth MBRP class

Study Arms (2)

MBRP group

EXPERIMENTAL

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

usual care

NO INTERVENTION

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)

Interventions

MBRP group BEHAVIORAL

same as arm description

MBRP group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Tung Wah Group for Hospital Integrated Centre: collaborator

Study Sites (1)

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

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 29, 2019
• Study Start: July 24, 2019
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: August 31, 2021

Record last verified: 2021-08

Locations

HK (1)