Clinical Trials Directory

Trials / Completed

CompletedNCT07510256

Effects of Breathwork and Meditation on Addiction Recovery

Effects of SKY Breathwork and Meditation Program on Emotional Well-being and Craving in Individuals Recovering From Substance Use Disorder

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
100 (actual)
Sponsor
University of California, Los Angeles · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Emotional wellness can play a vital role in supporting recovery from substance use disorder (SUD). Developing skills to regulate emotions and manage stress during early stages of recovery can help manage triggers and prevent relapse. Controlled breathing (i.e., intentional manipulation of rate and/or depth of breathing over time - often referred to as "breathwork") can enhance emotion regulation, but their effects have been minimally studied in individuals recovering from SUD. This randomized controlled pilot study will examine the impact of breathwork and meditation training program ("SKY Recovery") designed for people in substance use recovery. It will take place at a residential substance use recovery treatment center in upstate New York with patients in recovery who have elected to participate in the SKY Recovery program delivered at the treatment center. The study will compare two groups (SKY Recovery vs. Control) to assess the intervention's impact on emotional well-being and craving. Participants randomized to the SKY group will complete a 5-day intensive workshop followed by weekly follow-up sessions. The Control group will receive the same intervention after a delay. Validated measures of emotion regulation, craving, and sleep quality will be collected at baseline, one week after the program, and again 3 weeks after the program to determine efficacy and feasibility for a larger trial.

Detailed description

Emotional wellness can play a vital role in supporting recovery from substance use disorder. Developing skills to regulate emotions and manage stress during early stages of recovery can help manage triggers and prevent relapse. Controlled breathing (i.e., intentional manipulation of rate and/or depth of breathing over time - or "breathwork") can enhance emotional wellbeing (e.g., improve emotion regulation), but very little research has explored the impact of breathwork as a healthy coping mechanism for managing emotions and triggers in the context of recovery from substance use disorder. The goal of this study is to obtain initial data on efficacy of a biopsychosocial intervention that involves breathwork as an adjunct to standard care in a residential treatment setting. Biopsychosocial interventions (e.g., "SKY Recovery") that focus on breathwork techniques, such as Sudarshan Kriya Yoga (SKY), reduce stress, anxiety and depressive symptoms in healthy individuals as well as those with depression, anxiety, and Post-traumatic Stress Disorder. They also reduce craving and withdrawal symptoms in people with Tobacco Use Disorder. Breathwork interventions improve quality of life, particularly in the psychological dimension, for people with opioid use disorder, reducing craving, depression, and increasing social and physical functioning. Craving and withdrawal symptoms promote the maintenance of addiction and predict return to substance misuse, and they are linked to the stress response in people who have substance use disorders. Results of prior studies thereby offer the promise of breathwork as adjunctive therapy for substance use disorder (SUD). Yet, breathwork has only minimally been examined in people with SUDs. The aims of this pilot study are to evaluate the effectiveness of the SKY Recovery program in individuals with SUDs on emotional wellbeing and craving. Emotion regulation, impulsivity, and distress tolerance will be measured as indicators of emotional wellbeing using self-report questionnaires. 100 adult participants (aiming for 50 male and 50 female, ≥18 years old) who are scheduled to participate in the SKY Recovery program in a residential community treatment center will be enrolled. They will be randomized to two groups: SKY and Control ("delayed start"). Participants in the SKY group will receive the SKY Recovery Program (5 days, 3 h/day) followed by guided weekly in-person group practice sessions (1 h) for 3 weeks. SKY is typically taught in groups; thus, patients will be trained in cohorts of 4-10 people. The delayed-start Control group will receive the SKY Recovery program after all measurements have been obtained from the SKY group. Measurements will be taken before and after the intensive 5-day SKY training, one week after, and again 3 weeks after . Emotional wellbeing (e.g., emotion regulation) will be measured using standardized self-report questionnaires. Craving for their primary substance of choice will be measured using a brief self-report questionnaire. As sleep is related to emotional wellness and is often disrupted in individuals with SUDs, we will also obtain self-report ratings of sleep quality. We will address the following specific aims: Aim 1. Evaluate the effects of SKY Recovery program on emotional wellbeing in patients receiving treatment for substance use disorder in a residential community setting. Hypothesis 1: Emotion regulation difficulties, impulsivity, and distress intolerance will be reduced and sleep quality will increase relative to baseline - more in the SKY group than in the Control group. Aim 2. Evaluate the effects of SKY Recovery program on craving in patients receiving treatment for substance use disorder in a residential community setting. Hypothesis 2: Craving will be reduced relative to baseline - more in the SKY group than in the Control group.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSKY Breathing ProgramThe main breathing technique taught in SKY Recovery program consists of multiple, staged components for progressively deeper relaxation and mental clarity. The first component involves a slow breathing technique (ujjayi or "ocean breath") that increases airway resistance during inspiration/expiration and controls airflow to prolong each breathing cycle to an exact count. The subjective experience is physical and mental calmness with alertness. In the second component ("bellows breath"), air is rapidly inhaled and forcefully exhaled at a rate of 30 breaths/minute, leading to excitation followed by calmness. The last component, Sudarshan Kriya ("proper vision by purifying action"), involves cyclical slow/medium/fast breathing. Together, these techniques can take 20 min and is followed by a 5 min rest period (total: 25 min). The program also includes training in mantra-based meditation (Sahaj Samadhi) - invoking a word ("mantra") to redirect the mind towards a meditative state.

Timeline

Start date
2024-11-18
Primary completion
2025-10-02
Completion
2025-10-02
First posted
2026-04-03
Last updated
2026-04-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07510256. Inclusion in this directory is not an endorsement.