Evaluating The Efficacy Of A Mind-Body Intervention In Overcoming Opioid Addiction

Not Applicable

Completed

• Conditions: Substance Use Disorders; Opioid Use; Opioid-use Disorder
• Interventions: Behavioral: Sky Intervention

• Registration Number: NCT03791645
• Lead Sponsor: Ohio State University

Brief Summary

This study demonstrates the feasibility, acceptability of SKY program as an adjuvant therapy for American population suffering with OUD through a pilot program in Columbus, Ohio. The aim of this study is to evaluate the SKY program as an adjuvant therapy to treat opioid addiction.

Detailed Description

This research proposal aims to test the feasibility, acceptability and efficacy of SKY (Sudarshan Kriya Yoga) program, a mind-body intervention, as an adjuvant therapy for people suffering with opioid use disorder (OUD), in Columbus, Ohio. Previous research carried out in India in 2015, has demonstrated that SKY significantly improved the quality of life among people with OUD, however, the suitability, acceptability of SKY program has not been tested among American population. SKY differs from mindfulness and other meditation processes in that, it is a more physiological, rather than cognitive process. It involves controlled breathing techniques that can be easily mastered, and do not require mental effort. The investigator's goals are to a) DEMONSTRATE the feasibility, acceptability and efficacy of SKY program as an adjuvant therapy for American population suffering with OUD. Studies will be carried out in OUD subjects at Mary Haven clinic in Columbus. The efficacy of SKY will be measured using psychometric questionnaires. Feasibility and acceptability will be measured by attendance and attrition.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-10-27
• Study First Submitted: 2018-11-07
• Study First Submitted QC: 2018-12-31
• Study First Posted: 2019-01-02
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-11
• Last Update Posted: 2022-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• The proposed participants are currently residents of Mary Haven
• Are currently undergoing addiction treatment which may include medication assisted treatment as well as counseling.
• The intervention is designed for adults, therefore, only individuals 18 and above will be included in the study.

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Exclusion Criteria

• Pregnant women who are beyond their first trimester are excluded from the study as the program requires breathing techniques that are not recommended for pregnant women.
• Also, patients diagnosed with schizophrenia and bipolar disorder will also be excluded from the study, as SKY program is not suitable for people with these conditions.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SKY Intervention	Sky Intervention	Participants in the intervention group will get to participate in the SKY program, for 5 days with each day session taking 3 hours/day. SKY program involves a) specific breathing exercises and social interaction with other participants in the program. Following completion of the program, another set of questionnaires will be administered to collect information regarding stress, mood, and opioid use. After completion of the 5 day SKY program, participants will practice SKY every day at home for 30 days. They will also need to attend 4 weekly group sessions during this period and each session is expected to last 1 hour. At the end of the 30 day period, another set of questionnaires will be administered to collect information regarding stress, mood, and opioid use.

Primary Outcome Measures

Name	Time	Method
Change in psychological health following the Sudarshan Kriya Yoga (SKY) therapy	Before SKY intervention, 1 hour after intervention and 1 month after intervention	Change in psychological health will be measured using psychometric test administered to subjects at Signature Health clinic in Ashtabula, Ohio. The Pychometric test will involve completion of a Basic 24 Questionnaire: It is a leading behavioral health assessment tool which consists of 24 questions that cover depression and functioning.
Change in the number of participants that complete the Sudarshan Kriya Yoga (SKY) therapy	Time 1 = initial therapy session, Time 2 = week 1 post therapy session, Time 3 = week 2 post therapy session Time 4 = week 3 post therapy session, Time 5 = week 4 post therapy session Time 6 = 30 minutes daily home practice for 30 days	To study the acceptability of the SKY program as an adjuvant therapy for American population suffering with mental disorders + opioid addiction, the attendance and attrition of the subjects at the Signature Health clinic in Ashtabula in the SKY therapy sessions will be recorded by keeping record of those that complete each progressive therapy session.

Trial Locations

Locations (1)

The Ohio State University College of Social Work; 🇺🇸 Columbus, Ohio, United States