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Effect of Yoga on Reducing Craving in Tobacco Dependent Individuals

ConditionTobacco Dependence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-65
SponsorUniversity of Pittsburgh

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

-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

Disqualifiers

-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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Yoga

    Behavioral

    Participants in yoga arm will receive intervention from an instructor who would be trained in the intervention by the yoga adviser.All the yoga exercises selected for this study are low-impact and involve highly controlled movements. All yoga exercises will be taught and supervised by a skilled yoga-instructor. The yoga-instructor will take great care to emphasize to participants that they should not go beyond their usual range of motion/comfort for any of the yoga exercises.

  • WHO 5As model intervention

    Behavioral

    WHO 5As model to help patients ready to quit. The five major steps to intervention are the "5 A's": Ask, Advise, Assess, Assist, and Arrange.

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Intervention-yogaExperimental treatment 1 intervention
Group B: WHO 5As model interventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of yoga based intervention

To evaluate the feasibility of yoga-based intervention in changing craving of tobacco in comparison to WHO 5As intervention on individuals who want to quit tobacco use with Visual Analogue scale (upto score 3 not useful: scores 4,5,6 neutral; 7,8,9, 10 useful) Minimum score is 0 and maximum score is 10

Time frame
After one week of intervention
2

Craving of tobacco after intervention

To evaluate the feasibility of yoga-based intervention in changing craving of tobacco measured by Brief Questionnaire of Smoking Urges in comparison to WHO 5As intervention on individuals who want to quit tobacco use using (Scale is 10 items likert scale and total of all item scores is the score, more the score more is the craving)Minimm score is 0 and maximum is 100.

Time frame
After one week of intervention
3

Craving of tobacco one month follow up

To evaluate the feasibility of yoga-based intervention in changing craving of tobacco measured by Brief Questionnaire of Smoking Urges in comparison to WHO 5As intervention on individuals who want to quit tobacco use (Scale is 10 items likert scale and total of all item scores is the score, more the score more is the craving) Minimum score is 0 and maximum is 100.

Time frame
1 month after intervention
4

Craving of tobacco three months follow up

To evaluate the feasibility of yoga-based intervention in changing craving of tobacco (Scale is 10 items likert scale and total of all item scores is the score, more the score more is the craving)measured by Brief Questionnaire of Smoking Urges in comparison to WHO 5As intervention on individuals who want to quit tobacco use. The minimum score is 0 and maximum score is 100.

Time frame
3 months after intervention

Secondary outcomes

1

Relapse rate of tobacco use (Number of participants start using tobacco again)

To compare effect of yoga Relapse rate of tobacco use on abstinence with WHO 5As intervention group

Time frame
After one week of intervention
2

Relapse rate of tobacco use(One month sustainability) ((Number of participants start using tobacco again)

To compare effect of yoga intervention on relapse rate of tobacco use with WHO 5As intervention group

Time frame
1 month after intervention
3

Relapse rate of tobacco use (Three months sustainability)(Number of participants start using tobacco again)

To compare effect of yoga intervention on relapse rate of tobacco use with WHO 5As intervention group

Time frame
3 months after intervention
4

Quit rate of tobacco

To compare the change in quit rate after yoga intervention with WHO 5As intervention group

Time frame
After one week of intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pittsburgh

Lead sponsor

Fogarty International Center of the National Institute of Health

Collaborator

St.John's Medical College and Hospital

Collaborator

Source ClinicalTrials.gov
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