Effect of Yoga on Reducing Craving in Tobacco Dependent Individuals

University of Pittsburgh

Status: Enrolling

Conditions: Tobacco Dependence

Treatments: Behavioral: WHO 5As model intervention; Behavioral: Yoga

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06488443

D43TW009114 (U.S. NIH Grant/Contract)

STUDY23050176

Details and patient eligibility

About

Yoga is a culturally acceptable practice that can reduce craving and help people quit tobacco. There is a need to evaluate the feasibility of implementation of a well- designed yoga protocol to address craving in individuals who use tobacco in India.

Full description

There is a high prevalence of tobacco use in the community that continue to remain underserved in terms of intervention and support for their tobacco use. Yoga is a culturally acceptable practice that can reduce craving and help people quit tobacco. However, we didn't come across Indian studies looking at yoga to reduce craving in individuals who use tobacco. There is a need to evaluate the feasibility of implementation of a well- designed yoga protocol to address craving in individuals who use tobacco in India.

Aim: To study the feasibility of yoga in reducing craving in individuals who use tobacco

Objectives:

Primary

• To evaluate the feasibility of yoga based intervention on craving in tobacco dependent individuals who want to quit tobacco use Secondary/tertiary
• To assess the effect on abstinence
• To assess quit rate

Sampling frame:

Screened positive participants will be recruited from Rural community health and training centre, Mugalur, Tobacco cessation centre and OPDs of Department of general medicine, pulmonary medicine, cardiology, oncology, ENT and dental surgery and other super speciality OPD at SJMCH

.

Sample recruitment/sampling method:

Participants who fulfilled the inclusion criteria will be approached by the principal investigator and/or junior research fellow, and those who agreed to participate in the study will be randomly allocated to one of two groups via simple randomization. Randomisation will be computerised. This will be done in blocks of 10. Outcome assessor will be blinded to the randomisation. Principal investigator will not be involved in randomization of participants.

Training/ interventions/assessments/ procedures in the study -Participants in yoga arm will receive intervention from an instructor who would be trained in the intervention by the yoga adviser.

Procedure:

Screening positive participants fulfilling eligibility criteria, information regarding study is given and informed consent is documented. Selection of a quit date within 21 weeks.

Standard of living index(SLI) or Modified Kuppuswamy Scale for sociodemographic data (10mins), Fagerstrom scale(5 mins), Motivation to stop smoking (1 min) .

Participants are randomized into intervention and TAU groups with 48 participants each.

For intervention group, sixty minute yoga session will be imparted. The first session shall be offline, the rest of the 6 sessions shall be online.. After Completion all assessments will be done again both of intervention and TAU groups.Follow up at 21 weeks, 1 month and at 3 months.

-To assess relapse

Hypothesis Yoga will be a feasible method to reduce craving in tobacco dependent individuals who want to quit tobacco use

Enrollment: 96 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• -Tobacco dependent individuals (Fagerstrom test for tobacco dependence score more than or equal to 4)

  • -Men aged 18 to 65 years
  • -Recruited from Rural community health and training centre, Mugalur, Tobacco cessation centre and OPDs of Department of general medicine, pulmonary medicine, cardiology, oncology, ENT and dental surgery and other superspeciality OPD at SJMCH

Exclusion criteria

Patients with recent alcohol use (last 3 months) and use of other drugs of abuse

• -Patients with clinical diagnosis of Intellectual disability

• -Comorbid Major mental illness including Dementia, Psychosis, Recurrent depressive disorder, Bipolar affective disorder, OCD, generalized anxiety disorder, Panic disorder and Phobias, diagnosed within the last 6 months.

• -Patients with recent MI and stroke in the last 3 months or those physically unable to perform the yoga postures due to physical disabilities determined by clinical interview.

  • -Patients with severe hypertension(SBP≥180mmHg and BP≥120mmHg)
  • -Patients with seizures disorder
  • -Patients with COPD(GOLD-2,3 and 4)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups

Intervention-yoga

Experimental group

Description:

Participants in intervention arm will receive intervention from an instructor who would be trained in the intervention by the yoga adviser. One week of yoga intervention with the first session offline and the rest of the 6 sessions online

Treatment:

Behavioral: Yoga

WHO 5As model intervention

Active Comparator group

Description:

The control group will be given the WHO 5As model intervention to help patients ready to quit.

Treatment:

Behavioral: WHO 5As model intervention