Group Activities to Support Addiction Recovery

Not Applicable

Recruiting

• Conditions: Addiction; Substance Use Disorders (SUD)

• Registration Number: NCT07071883
• Lead Sponsor: University of Nebraska

Brief Summary

The purpose of this study is to pilot the use of Holotropic Breathwork (HB) for individuals seeking to recover from addiction. The study will have two arms: A--for individuals in residential treatment programs, B--for individuals living in the community. Arm A will use a cluster randomized intervention, providing HB for individuals at two facilities and a Multiple Modality (MM) intervention (yoga, meditation, and a film/discussion) at a third facility. In Arm B, we seek to measure the feasibility, acceptability, and preliminary impact of HB among people with addiction living in the community. Arm B will be comprised of a single group and participants in this group will receive the same HB experience as the participants in the Arm A HB group. HB is the practice of self-directed hyperventilation while lying down with the support of a selected music set and trained facilitators. Participants may experience an expanded state of consciousness with altered cognition, perception, and emotions. HB has been associated improved mental functioning among the general public and people in addiction treatment, but has never been evaluated in a controlled trial. Inclusion criteria consist of being 19 years of age or older and having met criteria for a substance use disorder within the past five years. Additional inclusion criteria for participants in arm A include being in a residential addiction treatment program at CenterPointe or the Bridge.

Exclusion criteria form the Arm A HB group and the Arm B group include having been diagnosed with a bipolar disorder or a psychotic disorder or having had psychotic symptoms at any point in life, diagnosed with a cardiac condition, received care for a cardiac condition, or have current cardiac symptoms, ever diagnosed with a seizure disorder, current uncontrolled hypertension (140/90 or greater), diagnosed with glaucoma or retinal detachment, recent surgeries, or currently pregnant. Four breathwork sessions will be held: two at the UNMC College of Nursing in Lincoln, one at CenterPointe in Omaha, and one at The Bridge in Lincoln. One MM session will be held at CenterPointe in Lincoln.

Detailed Description

ClinicalTrials.gov Protocol Description Study Design Overview This is a non-randomized interventional study comparing Holotropic Breathwork (HB) with a Multiple-Modality (MM) activity day in individuals with substance use disorders. Participants are recruited from residential treatment programs and community-based addiction recovery populations.

Arms and Interventions Arm A: Residential Participants HB Group Participants in residential treatment (CenterPointe Omaha and The Bridge Lincoln) will be offered Holotropic Breathwork (HB). Up to 30 individuals may participate per session. Sessions include screening for pregnancy and elevated blood pressure, opening circle, 60-minute introductory presentation, HB session with guided breathing and music (2 hrs 20 min), post-HB integration discussion, role reversal, and a closing circle.

MM Group Participants at CenterPointe Lincoln will take part in the Mindfulness and Movie activity day, including an opening circle, educational presentation on yoga and meditation, yoga and meditation sessions, catered lunch, screening and group discussion of the film 'Ben is Back', and a closing circle.

Arm B: Community Participants Community members in addiction recovery will participate in HB sessions conducted at UNMC College of Nursing, CenterPointe Omaha, and The Bridge Lincoln. Recruitment will be done via flyers, social media, and word-of-mouth. Sessions follow the same structure as Arm A HB group.

Participant Eligibility

Inclusion Criteria:

• - Adults currently in recovery from addiction (any substance)

* Any point in recovery

* Arm A participants must be enrolled in residential treatment

Exclusion Criteria:

• - Positive urine pregnancy test

* Blood pressure ≥ 140/90

* Current suicidal ideation or plans (via PHQ-9) Recruitment Procedures Arm A: PI works with clinical staff to identify eligible participants, presents study using video/script, and obtains individual consent.

Arm B: Flyers and social media used for recruitment. Interested individuals email PI and confirm review of materials before enrollment.

Data Collection Schedule Data will be collected at Baseline, \<24h Post-Session, and 1, 3, and 6 months. Measures include demographics, substance use (TLFB, Craving), PHQ-9, GAD-7, SIFS, PIL-SF, PILS-6, CEQ, EBI, and Acceptability Survey.

Safety and Risk Monitoring Participants with high PHQ-9 scores or suicidal thoughts will be evaluated immediately. Pregnancy and BP screenings will be conducted. Unsteady participants will be transported home by a same-sex facilitator. Emotional distress will trigger same-day and next-day follow-ups.

Integration and Follow-up Zoom-based integration groups offered 5-7 and 12-14 days post-HB, led by certified facilitators and apprentices. No data will be collected during these sessions. Follow-up surveys will continue through 6 months via REDCap.

Participant Locations

• - Arm A HB: CenterPointe Omaha, The Bridge Lincoln

* Arm A MM: CenterPointe Lincoln

* Arm B HB: UNMC College of Nursing, CenterPointe Omaha, The Bridge Lincoln

Study Timeline

• Study First Submitted: 2025-07-08
• Study First Submitted QC: 2025-07-08
• Study First Posted: 2025-07-17
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-05
• Last Update Posted: 2025-08-11
• Study Start: 2025-08-15
• Primary Completion: 2026-03-14
• Study Completion: 2026-03-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Arm A 19 years of age or older Currently enrolled in a residential addiction treatment program at CenterPointe or the Bridge Met criteria for a substance use disorder in the past five years
• Arm B 19 years of age or older Met criteria for a substance use disorder in the past five years

Exclusion Criteria

• Arm A: HB group and Arm B

  1. Diagnosed with a bipolar disorder at any point in life (per self-report)
  2. Diagnosed with a psychotic disorder or have had psychotic symptoms at any point in life (per self-report)
  3. Diagnosed with a cardiac condition, received care for a cardiac condition, or have current cardiac symptoms (per self-report)
  4. Ever diagnosed with a seizure disorder (per self-report)
  5. Current uncontrolled hypertension (140/90 or greater) (measured the morning of the breathwork)
  6. Ever diagnosed with glaucoma or retinal detachment
  7. Recent surgeries
  8. Currently pregnant (individuals who have engaged in sexual activity since their last menstrual period will be asked to submit a urine sample for a pregnancy screen the morning of the breathwork)
  9. Acutely suicidal (i.e. with an intention and a plan)

• Arm A: MM group None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants reporting a change in their substance use	1 month, 3 months, and 6 months	Timeline Followback (TLFB)

Secondary Outcome Measures

Name	Time	Method
Change in Psychological Insight	Baseline, <24 hours post-session, 1 month, 3 months, and 6 months	Psychological Insight Scale (PILS-6)
Change in Depression Symptoms	Baseline, 1 month, 3 months, and 6 months	Patient Health Questionnaire-9 (PHQ-9)
Change in Anxiety Symptoms	Baseline, 1 month, 3 months, and 6 months	Generalized Anxiety Disorder-7 (GAD-7)
Change in Interpersonal Functioning	Baseline, 1 month, 3 months, and 6 months	Self and Interpersonal Functioning Scale (SIFS)
Change in Purpose in Life	Baseline, 1 month, 3 months, and 6 months	Purpose in Life Test - Short Form (PIL-SF)
Change in Cravings	Baseline, 1 month, 3 months, and 6 months	Brief Craving Scale
Mystical Experiences	<24 hours post-session	Mystical Experiences Questionnaire (MEQ)
Challenging Experiences	<24 hours post-session	Challenging Experiences Questionnaire (CEQ)
Emotional Breakthrough	<24 hours post-session	Emotional Breakthrough Inventory (EBI)
Acceptability of the Intervention	<24 hours post-session and 1 month	Custom Acceptability Survey

Trial Locations

Locations (1)

University of Nebraska Medical Center; 🇺🇸 Lincoln, Nebraska, United States