Evaluating The Efficacy Of A Mind-Body Intervention In Overcoming Opioid Addiction
Condition: Opioid Use; Opioid-use Disorder; Substance Use Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Study type: Interventional

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.
    

Intervention name(s): Sky Intervention
Intervention type(s): Behavioral
Intervention description(s): 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.
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
Masking: None (Open Label)
Primary purpose: Supportive Care