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Completed

NCT Number: NCT03930329

Mindfulness-based Treatment to Prevent Smoking Relapse

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hong Kong

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MBRP group

Behavioral

same as arm description

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Tung Wah Group for Hospital Integrated Centre

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 29, 2019
Registry last updated
Aug 31, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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