Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
100 participants
INTERVENTIONAL
2025-08-27
2026-03-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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 The Bridge in Lincoln.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Study Overview
The project includes two primary participant groups:
Arm A - Residential Participants
Participants are recruited from two residential treatment programs (CenterPointe Omaha and The Bridge Lincoln). This arm uses cluster randomization: two sites will host the HB intervention, while an independent residential cohort at The Bridge will receive the MM intervention. Participants at each site receive the intervention assigned to their facility.
Arm B - Community Participants
Community members in addiction recovery are recruited via flyers, social media, and word-of-mouth. Arm B participants receive HB only and are included to evaluate feasibility, acceptability, and pre/post changes in functioning.
Across both arms, participants are evaluated at baseline, \<24 hours post-intervention, and at 1-, 3-, and 6-month follow-up.
Rationale and Scientific Framework
Holotropic Breathwork is a structured, facilitator-led breathing practice designed to produce non-ordinary states of consciousness without the use of pharmacological agents. Prior research suggests HB may improve psychological, interpersonal, and existential functioning-domains strongly associated with addiction recovery.
Guided by conceptual models from psychedelic-assisted therapy research, this study hypothesizes that HB may elicit:
Mystical-type experiences
Challenging experiences
Emotional breakthroughs
These experiences may lead to psychological insight, which may contribute to improvements in mood, interpersonal relationships, existential wellbeing, and ultimately reductions in cravings or lapses.
Interventions Holotropic Breathwork (HB)
HB sessions may include up to 30 participants and follow a standardized protocol conducted by certified facilitators and trained apprentices (approximate facilitator-to-breather ratio 1:5).
HB events comprise the following elements:
Pre-Session Screening
Urine pregnancy test for participants who could become pregnant
Seated blood pressure measurement (must be \<140/90)
Review of PHQ-9 to identify acute suicide risk
Assessment of medical and psychiatric exclusion criteria
Opening Circle
Participant introductions
Review of confidentiality, safety expectations, and session agreements
Educational Presentation (\~60 minutes)
Content includes:
History and principles of HB
Hylotropic vs. holotropic states
Grof's cartography of the psyche (biographical, perinatal, and transpersonal domains)
COEX systems and emotional memory patterns
Strategies for navigating challenging experiences
Roles of breathers and sitters
Individual Readiness Check-ins Each participant meets briefly with a facilitator to assess emotional readiness and address questions.
Breathwork Session (\~2 hours 20 minutes)
Participants lie on mats, typically using eyeshades
Guided relaxation prompts followed by intensified, self-paced breathing
Purposefully sequenced music supports the internal process
Sitters provide assistance only upon explicit request
Facilitators monitor safety continuously and may support participants through physical expressions of emotional release, ensuring all touch is participant-directed and consent-based
Post-Session Processing
Brief one-on-one check-ins with a facilitator
Participants may draw, write, or rest
Integration Presentation (\~60 minutes)
Overview of formal and informal integration practices
Guidance on self-care, managing stimulation, and delaying major decisions
Discussion of appropriate sharing of HB experiences
Closing Circle Participants share reflections voluntarily; additional one-on-one support is available.
HB sessions conducted in Arm B follow the same structure and staffing.
Multiple-Modality (MM) Activity Day (Arm A Comparator)
The MM day is an attention-matched comparator condition designed to provide supportive, group-based activities without inducing non-ordinary states of consciousness. It is delivered only at The Bridge Lincoln.
The MM session includes:
Opening Circle Participants introduce themselves and may share recovery reflections.
Sound Bath Introduction Video (7 minutes) A brief educational video describing sound-based relaxation practices.
Sound Bath Session (20 minutes) Participants experience a guided sound bath in a quiet, low-stimulation environment.
Progressive Relaxation Exercise (11 minutes) A recorded body-relaxation sequence guides participants through calming techniques.
Film Screening (1 hour 43 minutes) Participants view Ben Is Back, a film depicting addiction and family dynamics.
Facilitated Group Discussion A trained UNMC nursing faculty member leads a structured conversation on themes from the film.
Closing Circle Participants may share insights or reflections before the session ends.
Unlike HB, MM activities pose no known physiological risks; therefore individuals excluded from HB remain eligible for the MM day.
Eligibility Criteria Inclusion Criteria
Adults aged 19 and older
Met criteria for a substance use disorder within the past 5 years
Arm A participants must be enrolled in residential treatment
Exclusion Criteria for HB (Arm A HB and Arm B)
Participants are excluded from HB if any of the following apply:
Lifetime diagnosis of bipolar disorder
Psychotic disorder or lifetime history of psychotic symptoms
Cardiac condition, history of cardiac treatment, or current cardiac symptoms
Seizure disorder
Uncontrolled hypertension (≥140/90)
Glaucoma or retinal detachment
Recent significant surgeries
Pregnancy
Acute suicidal ideation with plan or intent
These exclusions do not apply to MM participants.
Recruitment and Informed Consent Arm A (Residential)
The PI works with clinical staff to identify eligible residents. The PI delivers a standardized presentation, answers questions, and obtains individual informed consent in a private setting.
Arm B (Community)
Recruitment materials are posted through treatment centers, recovery organizations, and social media. Interested individuals contact the PI, receive study information, and complete consent via Zoom or in private at a participating site.
Data Collection and Outcome Measures
Assessments occur at:
Baseline
\<24 hours post-session
1 month
3 months
6 months
Measures include:
Substance use: Timeline Followback, craving scale
Mental health: PHQ-9, GAD-7
Interpersonal functioning: SIFS
Existential functioning: PIL-SF
Psychological insight: PILS-6
Experiential measures: Mystical Experience Questionnaire, Challenging Experience Questionnaire, Emotional Breakthrough Inventory
Acceptability surveys
All follow-up surveys are administered through REDCap.
Safety Monitoring
Participant safety is supported by:
Continuous facilitator monitoring during HB sessions
Immediate exclusion of participants with elevated BP or positive pregnancy test
Real-time review of PHQ-9 scores by the PI
Same-day and next-day follow-ups for participants experiencing significant emotional reactions
Transportation assistance for participants who are physically unsteady
Emergency protocols including activation of emergency medical services when indicated
Stopping Rule
The study will be halted if more than 15% of participants require outside medical or psychiatric treatment related to the intervention.
Integration Support
HB participants are invited to attend two optional Zoom-based integration groups held:
5-7 days post-session
12-14 days post-session
Sessions are led by certified facilitators and apprentices. These groups offer guidance and reflection but do not involve data collection.
Statistical Analysis
Paired-samples t-tests will evaluate pre-post changes within HB participants.
Chi-square tests will compare cravings and lapses between HB and MM groups in Arm A.
Feasibility and acceptability metrics will include recruitment yield, attrition, survey completeness, and qualitative acceptability responses.
The study is not powered for definitive clinical outcomes but will provide effect-size estimates and procedural feasibility data to inform larger trials.
Potential Benefits and Risks
Participants may experience reductions in stress or anxiety, emotional release, heightened psychological insight, and enhanced purpose or meaning in life. Risks include temporary dizziness, emotional discomfort, recollection of traumatic events, and other transient psychological reactions. HB has a long history of safe use when conducted by certified facilitators.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A--for individuals in residential treatment programs
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.
Holotropic breathwork
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.
Multiple modality
Multiple Modality (MM) intervention (yoga, meditation, and a film/discussion)
B--for individuals 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
Holotropic breathwork
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Holotropic breathwork
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.
Multiple modality
Multiple Modality (MM) intervention (yoga, meditation, and a film/discussion)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Arm B 19 years of age or older Met criteria for a substance use disorder in the past five years
Exclusion Criteria
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
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Nebraska
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nicholas Guenzel
Assistant professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nicholas Arien Guenzel, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Nebraska
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Nebraska Medical Center
Lincoln, Nebraska, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Nicholas Guenzel, PhD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0449-24-FB
Identifier Type: -
Identifier Source: org_study_id