Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SKY Recovery Intervention | Experimental | The SKY Recovery program centers around a breathing meditation technique, called Sudarshan Kriya Yoga, which consists of multiple, staged components designed to progressively deepen relaxation and bring mental clarity. Participants also learn a mantra-based meditation technique that complements the breathwork. The program also includes education on emotion regulation practices (e.g., cognitive reframing). |
|
| Delayed-start Control | No Intervention | 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 Recovery program, one week later, and at the end (4 weeks after initiation) of the weekly guided practice period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SKY Breathing Program | Behavioral | The 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Emotion regulation | Emotional well-being is a critical factor in stabilized recovery from substance use disorders. Emotion regulation will be measured as an indicator of emotional well-being (primary endpoint) using a standardized self-report questionnaire. The Difficulties in Emotion Regulation Scale is a widely used self-report questionnaire designed to assess problems with emotion regulation, especially how people understand, accept, and manage their emotional responses. We will use the brief version (18-items, Victor & Klonsky, 2016). This will be obtained a few days before the SKY Recovery program, 1 week after, and 3 weeks after. | 6 weeks |
| Craving | Craving is one of the indicators of recovery from substance use disorder and is closely tied to emotional well-being. Craving for the participant's primary substance of choice will be assessed via self-report using a brief craving scale. The Craving Scale (McHugh et al., 2021) consists of three questions assessing desire to use the substance of choice (1) within the last 24 hours, (2) when imagining being in an environment where the substance was previously used, and (3) when something in the environment reminds them of using the substance. This will be obtained a few days before the SKY Recovery program, 1 week after, and 3 weeks after. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Impulsivity | Impulsivity is an aspect of emotional well-being, often reflecting how well emotions are being regulated. We will use the UPPS Impulsive Behavior Scale (Whiteside & Lynam, 2001), developed to measure four facets of impulsivity: urgency, lack of premeditation, lack of perseverance, and sensation-seeking. We will use the short version (20 items; Cyders et al., 2014). This will be obtained a few days before the SKY Recovery program, 1 week after, and 3 weeks after. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Horizon Health Inpatient and Residential Addiction Recovery | Sanborn | New York | 90024 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016739 | Behavior, Addictive |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D064419 | Chemically-Induced Disorders |
Not provided
Not provided
This is a delayed-start (or "wait-list") controlled study. Control participants on the wait-list will receive treatment as usual during data collection. They will receive the intervention after their participation in data collection has been completed.
Not provided
Not provided
Not provided
Not provided
|
| 6 weeks |
| Distress intolerance | Distress intolerance is a central aspect of emotional well-being that often precedes craving for substances. It will be measured using the Distress Intolerance Index (DII; McHugh & Otto, 2012b), a 10-item self-report measure designed to assess the inability to tolerate negative states. This will be obtained a few days before the SKY Recovery program, 1 week after, and 3 weeks after. | 6 weeks |
| Sleep Quality | Sleep quality is another important aspect of emotional well-being which can be significantly impacted by substance use. We will measure sleep quality using the Pittsburgh Sleep Quality Index (PSQI)-Brief (Sancho-Domingo et al., 2020), a 6-item questionnaire. Higher scores indicate more difficulty with sleep. This will be obtained a few days before the SKY Recovery program, 1 week after, and 3 weeks after. | 6 weeks |
| D001523 |
| Mental Disorders |