Clinical trial NCT03791645: Evaluating The Efficacy Of A Mind-Body Intervention In Overcoming Opioid Addiction
Official title: Evaluating The Efficacy Of A Mind-Body Intervention In Overcoming Opioid Addiction, In Adults Undergoing Opioid Addiction Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Opioid-use Disorder
Substance Use Disorders
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2019-01-02
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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

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.

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.

Primary outcomes:
measure: Change in psychological health following the Sudarshan Kriya Yoga (SKY) therapy
timeFrame: Before SKY intervention, 1 hour after intervention and 1 month after intervention
measure: Change in the number of participants that complete the Sudarshan Kriya Yoga (SKY) therapy
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Social Work
state: Ohio
Study officials:
affiliation: Ohio State University
name: Keith Warren, PhD
role: PRINCIPAL_INVESTIGATOR
References: