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

Primary Purpose

Opioid Use, Opioid-use Disorder, Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sky Intervention
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Opioid Use

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

  • The Ohio State University College of Social Work

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SKY Intervention

Usual treatment

Arm Description

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.

Participants assigned to the control group will not have access to the SKY program but will continue with usual care. They will also complete questions after 5 days and again after 30 days.

Outcomes

Primary Outcome Measures

Change in psychological health following the Sudarshan Kriya Yoga (SKY) therapy
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
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.

Secondary Outcome Measures

Full Information

First Posted
November 7, 2018
Last Updated
October 11, 2022
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT03791645
Brief Title
Evaluating The Efficacy Of A Mind-Body Intervention In Overcoming Opioid Addiction
Acronym
SKY
Official Title
Evaluating The Efficacy Of A Mind-Body Intervention In Overcoming Opioid Addiction, In Adults Undergoing Opioid Addiction Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 27, 2018 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Opioid-use Disorder, Substance Use Disorders

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
SKY program includes gentle stretches, SK breathing, and cognitive coping and stressor evaluation strategies. SK breathing, the cornerstone of SKY program contains the following breathing components 1) Three-stage Ujjayi, 2) Bhastrika and 3) Rhythmic Breathing. Three-Stage Ujjayi is an advanced form, with each respiratory cycle lasting approximately twenty seconds. Bhastrika, involves vigorous and faster breathing, at about 20 to 30 respiratory cycles lasting 60 seconds. Three 1-minute rounds of Bhastrika are each followed by 20 seconds of normal breathing. Rhythmic breathing are slow, medium, and fast breathing cycles in succession. Respiratory rates range from about 8-12 respiratory cycles lasting approximately 10 minutes. The participant rotates through these breathing patterns. Upon completion of SKY program, participants will be given a home SK practice which takes approximately 25 minutes daily. Once a week, a 60-90 minutes group follow up SKY session will be held
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SKY Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual treatment
Arm Type
No Intervention
Arm Description
Participants assigned to the control group will not have access to the SKY program but will continue with usual care. They will also complete questions after 5 days and again after 30 days.
Intervention Type
Behavioral
Intervention Name(s)
Sky Intervention
Intervention Description
SKY meditation has three sequential components of breathing interspersed with normal breathing. These include a) sound breath: breathing against airway resistance with slight tightening of the laryngeal muscles, (2-3 cycles/min) followed by b) bellows breath: rapid, forced expiration(20-30 cycles/min) and c) regulated, rhythmical breathing rotating through medium to fast cycles. Each session is focused upon proper breathing techniques, social interaction, and discussion of practical wisdom for everyday life to manage the mind and emotions. SKY will be administered over a 5 day period (~3 hours/day), followed by 4 weekly follow-ups (~90 min session/week) at Signature Health clinic situated in Ashtabula, Ohio.
Primary Outcome Measure Information:
Title
Change in psychological health following the Sudarshan Kriya Yoga (SKY) therapy
Description
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.
Time Frame
Before SKY intervention, 1 hour after intervention and 1 month after intervention
Title
Change in the number of participants that complete the Sudarshan Kriya Yoga (SKY) therapy
Description
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.
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Warren, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University College of Social Work
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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