Integrative Breathwork Intervention for Chronic Pain
NCT Number: NCT06546956
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Chronic Low-back Pain
Interventions: BEHAVIORAL: Integrative Breathwork Intervention
Sponsor: University of Florida
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-02
Completion Date: 2027-05-22
Locations: University of Florida, Gainesville, Florida, 32610, United States

Summary:
The proposed research is to develop and refine a multicomponent breathwork intervention, Guided Respiration Mindfulness Therapy, and to iteratively evaluate its feasibility, acceptability, and plausibility for clinically significant effects in people with chronic low back pain. This integrative breathwork intervention involves a 60-minute breathing session where the focus is to maintain a conscious connected breathing pattern (no pause between inhale and exhale), apply mindful acceptance to somatic sensations, and relax any physical tension. Each breathwork session will be delivered 1-on-1 in person by a trained facilitator. The treatment consists of 8 breathwork sessions, once per week for 8 weeks.

Primary Outcome Measures: Treatment Acceptability, Treatment acceptability and participant satisfaction of the breathwork intervention will be measured using the Client Satisfaction Questionnaire and several face valid items. (0-10; higher values = greater treatment acceptability and satisfaction)., Post-treatment (after the 8-week intervention)|Intervention Adherence, Percentage of intervention sessions attended by participants., Post-treatment (Week 8)|Participant Retention, Percentage of randomized participants who complete post-treatment assessment., Post-treatment (Week 8)|Change in Pain Intensity, The Pain, Enjoyment, and General Activities (PEG-3) scale will be used to assess pain intensity over the past week on average. (0-10; higher values = greater pain intensity)., Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.|Change in Pain Interference, The Pain, Enjoyment, and General Activities (PEG-3) will be used assess pain interference over the past week. (0-10; higher values = greater pain interference)., Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Secondary Outcome Measures: Treatment Credibility, Assessed using the 8-item Credibility and Expectancy Questionnaire where higher scores represent higher levels of treatment credibility. (1-9; higher values = greater treatment expectancy and credibility)., After Intervention session 3|Acute Treatment Effects, Assessed using face-valid items related to feelings and emotions immediately before and after each intervention session. Change scores will be calculated from post-intervention to pre-intervention. (0-4; higher scores = greater changes in acute subjective effects)., Before and after each intervention sessions (Weeks 1-8)|Change in Pain Catastrophizing, Assessed using the 13-item Pain Catastrophizing Scale. (Scores range from 0-52; higher scores represent higher levels of pain catastrophizing)., Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.|Change in Pain Self-Efficacy, Assessed using the 10-item Pain Self-Efficacy Scale. (0-6; higher scores represent higher levels of pain self-efficacy)., Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.|Change in Fear Avoidance Beliefs, Assessed using the 5-item Fear-Avoidance Beliefs Questionnaire-physical activity subscale. (0-6; higher scores represent higher levels of physical activity-related fear-avoidance beliefs)., Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.|Change in Physical Function, The PROMIS Physical Function-6b will be used assess pain dysfunction. (1-5; higher scores represent higher levels of physical function)., Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.|Change in Sleep Disturbance, Assessed using the PROMIS-Sleep Disturbance 8b scale. (1-5; higher scores represent higher levels of sleep disturbance)., Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.|Change in Sleep Related Impairment, Assessed using the PROMIS-Sleep Related Impairment 8a scale. (1-5; higher scores represent higher levels of sleep related impairment)., Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.|Change in Fatigue, Assessed using the PROMIS Fatigue-8a scale. (1-5; higher scores represent higher levels of fatigue over the past week)., Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.|Change in Stress, Assessed using the 4-item Perceived Stress Scale. (0-4; higher scores represent higher levels of subjective stress over the past month)., Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.|Change in Anxiety, Assessed using the Generalized Anxiety Disorder-2 Questionnaire. (0-3; higher scores represent higher levels of anxiety over the past 2 weeks)., Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.|Change in Depression, Assessed using the Patient Health Questionnaire-2.(0-3; higher scores represent higher levels of depression over the past 2 weeks)., Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.|Change in Multisensory Sensitivity, Assessed using the Multisensory Amplification Scale will be used to assess symptoms of central nervous system hypersensitivity, or central sensitization. (1-5; higher scores represent higher levels of sensory sensitivity)., Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.|Change in Interoception, Assessed using the Multidimensional Assessment of Interoceptive Awareness-2. (0-5; higher scores represent higher levels of interoception)., Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.|Change in Mindful Reappraisal of Pain Sensations, Assessed using the Mindful Reappraisal of Pain Sensations Scale. (0-6; higher scores represent higher levels of mindful reappraisal)., Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Other Outcome Measures: Psychological Insight, Assessed using the Psychological Insight Questionnaire. (0-5; higher scores represent greater levels of psychological insight)., Post-treatment (Week 8)