Mindfulness-based Treatment to Prevent Smoking Relapse

NCT ID: NCT03930329

Last Updated: 2021-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-24
• Study Completion Date: 2021-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

MBRP group

Intervention Type: BEHAVIORAL

same as arm description

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MBRP group

same as arm description

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tung Wah Group for Hospital Integrated Centre

UNKNOWN

Sponsor Role: collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Lee Kam Pui

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

NTEC-2019-smoke

Identifier Type: -

Identifier Source: org_study_id