<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03791645</url>
  </required_header>
  <id_info>
    <org_study_id>2018H0409</org_study_id>
    <nct_id>NCT03791645</nct_id>
  </id_info>
  <brief_title>Evaluating The Efficacy Of A Mind-Body Intervention In Overcoming Opioid Addiction</brief_title>
  <acronym>SKY</acronym>
  <official_title>Evaluating The Efficacy Of A Mind-Body Intervention In Overcoming Opioid Addiction, In Adults Undergoing Opioid Addiction Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study demonstrates the feasibility, acceptability of SKY program as an adjuvant therapy&#xD;
      for American population suffering with OUD through a pilot program in Columbus, Ohio. The aim&#xD;
      of this study is to evaluate the SKY program as an adjuvant therapy to treat opioid&#xD;
      addiction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research proposal aims to test the feasibility, acceptability and efficacy of SKY&#xD;
      (Sudarshan Kriya Yoga) program, a mind-body intervention, as an adjuvant therapy for people&#xD;
      suffering with opioid use disorder (OUD), in Columbus, Ohio. Previous research carried out in&#xD;
      India in 2015, has demonstrated that SKY significantly improved the quality of life among&#xD;
      people with OUD, however, the suitability, acceptability of SKY program has not been tested&#xD;
      among American population. SKY differs from mindfulness and other meditation processes in&#xD;
      that, it is a more physiological, rather than cognitive process. It involves controlled&#xD;
      breathing techniques that can be easily mastered, and do not require mental effort. The&#xD;
      investigator's goals are to a) DEMONSTRATE the feasibility, acceptability and efficacy of SKY&#xD;
      program as an adjuvant therapy for American population suffering with OUD. Studies will be&#xD;
      carried out in OUD subjects at Mary Haven clinic in Columbus. The efficacy of SKY will be&#xD;
      measured using psychometric questionnaires. Feasibility and acceptability will be measured by&#xD;
      attendance and attrition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 27, 2018</start_date>
  <completion_date type="Actual">March 31, 2022</completion_date>
  <primary_completion_date type="Actual">March 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_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.&#xD;
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.&#xD;
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</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in psychological health following the Sudarshan Kriya Yoga (SKY) therapy</measure>
    <time_frame>Before SKY intervention, 1 hour after intervention and 1 month after intervention</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the number of participants that complete the Sudarshan Kriya Yoga (SKY) therapy</measure>
    <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</time_frame>
    <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.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Opioid Use</condition>
  <condition>Opioid-use Disorder</condition>
  <condition>Substance Use Disorders</condition>
  <arm_group>
    <arm_group_label>SKY Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sky Intervention</intervention_name>
    <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.</description>
    <arm_group_label>SKY Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The proposed participants are currently residents of Mary Haven&#xD;
&#xD;
          -  Are currently undergoing addiction treatment which may include medication assisted&#xD;
             treatment as well as counseling.&#xD;
&#xD;
          -  The intervention is designed for adults, therefore, only individuals 18 and above will&#xD;
             be included in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women who are beyond their first trimester are excluded from the study as the&#xD;
             program requires breathing techniques that are not recommended for pregnant women.&#xD;
&#xD;
          -  Also, patients diagnosed with schizophrenia and bipolar disorder will also be excluded&#xD;
             from the study, as SKY program is not suitable for people with these conditions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Keith Warren, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ohio State University College of Social Work</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>November 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>October 11, 2022</last_update_submitted>
  <last_update_submitted_qc>October 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
    <mesh_term>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03791645
org study id: 2018H0409
nct id: NCT03791645
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Single Group Assignment
intervention 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
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in psychological health following the Sudarshan Kriya Yoga (SKY) therapy
time frame: Before SKY intervention, 1 hour after intervention and 1 month after intervention
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.
measure: Change in the number of participants that complete the Sudarshan Kriya Yoga (SKY) therapy
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
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.
arm group label: SKY Intervention
arm group type: Experimental
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 group label: Usual treatment
arm group type: No Intervention
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: Sky 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.
arm group label: SKY Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Keith Warren, PhD
role: Principal Investigator
affiliation: Ohio State University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Substance-Related Disorders
mesh term: Opioid-Related Disorders
sharing ipd: No