Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:26 PM
Study NCT ID:
NCT07219056
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-21
First Post:
2025-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safe & Sound Protocol in Adults With Trauma and SUD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants, all study staff including the PI, and clinical staff will be blinded to the group assignment. The PI will remain unblinded as they created the randomization design.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a two-armed, prospective, randomized, double-blind, sham-controlled clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-17', 'studyFirstSubmitDate': '2025-10-14', 'studyFirstSubmitQcDate': '2025-10-17', 'lastUpdatePostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in posttraumatic stress symptom scores pre-post between groups as measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).', 'timeFrame': 'Day 1 and Day 8', 'description': 'Linear mixed effects models for repeated measurements will be used to evaluate the difference in changes in posttraumatic stress symptom outcomes between treatment and sham group.'}, {'measure': 'Difference in anxiety symptom scores pre-post between groups as measured by the Generalized Anxiety Disorder-7 (GAD-7) scale.', 'timeFrame': 'Day 1 and Day 8', 'description': 'Linear mixed effects models for repeated measurements will be used to evaluate the difference in changes in anxiety outcomes between treatment and sham group.'}, {'measure': 'Difference in autonomic arousal symptom scores pre-post between groups as measured by the Body Perception Questionnaire Autonomic Symptoms - short form (BPQ-20 ANS).', 'timeFrame': 'Day 1 and Day 8', 'description': 'Linear mixed effects models for repeated measurements will be used to evaluate the difference in changes autonomic arousal outcomes between treatment and sham group.'}], 'secondaryOutcomes': [{'measure': 'Differences in positive and negative affect scores pre-post between groups as measured by the Positive and Negative Affect Schedule.', 'timeFrame': 'Day 1 and Day 8', 'description': 'Linear mixed effects models for repeated measurements will be used to evaluate the difference in changes in positive and negative affect outcomes between treatment and sham group.'}, {'measure': 'Changes in mindfulness scores pre-post between groups as measured by the Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)', 'timeFrame': 'Day 1 and Day 8', 'description': 'Linear mixed effects models for repeated measurements will be used to evaluate the difference in changes in mindfulness outcomes between treatment and sham group.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['substance use disorders', 'posttraumatic stress symptoms', 'anxiety'], 'conditions': ['Substance Use Disorders', 'Posttraumatic Stress Symptom', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'This study will explore whether the use of the Safe and Sound Protocol (SSP) app is an effective adjunct to treatment as usual (TAU) in individuals with co-occurring substance use disorders and trauma. This study will recruit 129 participants (100 completers) randomized to receive either active or sham SSP in addition to TAU. Participants will utilize the SSP for a minimum of three hours to a maximum of five hours for a total of seven days. Data will be collected at both pre- and post-test. Data to be collected will include measures on affect, anxiety, personality, mindfulness, and posttraumatic stress disorder symptoms. The SSP has shown effectiveness in reducing symptoms of anxiety, depression, and trauma symptoms in pilot studies conducted at other locations. This will be the first study to examine the effectiveness of SSP with individuals with co-occurring SUD and trauma.', 'detailedDescription': "The Safe and Sound Protocol (SSP) was developed by Dr. Stephen Porges based on his Polyvagal Theory that highlights the vagus nerve's influences on emotional and behavioral regulation, social connection, and fear/trauma responses.\n\nResearch examining the effectiveness of SSP with children and/or adults on the Autism Spectrum has shown improvement in social awareness and decline in auditory hypersensitivities and hypo-sensitivities, visual sensitivity, tactile hypersensitivities, selective eating and digestive problems. SSP has also been shown to reduce symptoms of anxiety, depression and autonomic reactivity in individuals engaged in speech therapy for voice and throat complaints.\n\nThere is on-going clinical research to examine the effectiveness of SSP in various populations, including those suffering from posttraumatic stress disorder (PTSD). In real-world data obtain through the SSP platform, just over half of individuals reporting clinical levels of PTSD symptoms as assessed on the Posttraumatic Checklist - 5 (PCL-5) had a reduction in symptoms to below the clinical threshold following the completion of SSP.\n\nSafe and Sound Protocol (SSP) Core is five hours of music therapy that is progressively filtered through a patented algorithm that highlights middle sound frequencies, the frequency most associated with cues of safety from human speech. This is designed to stimulate the vagus nerve by engaging the middle ear muscles and nerves to move out of defensive state of activation and activate the social engagement and calming system of the nervous system. SSP is designed to help participants regulate their nervous system to support reduction in distress and increased social connection.\n\nTo date, there is no research underway to examine the effectiveness of SSP for individuals experiencing posttraumatic stress symptoms and a substance use disorder (SUD). Individuals experiencing posttraumatic stress symptoms and SUD are hypothesized to benefit from a non-invasive treatment designed to regulate their autonomic nervous system, such as SSP."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ages 18 years old to 75 years old\n* In residential treatment for substance use disorder.\n* Has a history of trauma and is enrolled in Caron's trauma programming\n* Is proficient in English\n* Able to provide written informed consent.\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n\nExclusion Criteria:\n\n* Does not speak English\n* Age \\< 18 or \\> 75\n* Does not have a history of trauma\n* Active psychosis\n* Active or uncontrolled seizures\n* Tinnitus\n* Active suicidal ideation\n* Actively engaging in self-injurious behavior\n* Severe neurological condition\n* Diagnosis of autism\n* Has any serious medical disease or mental health condition which, in the judgment of the Principal Investigator or his/her designee, would make study participation unsafe, or would make intervention compliance difficult."}, 'identificationModule': {'nctId': 'NCT07219056', 'briefTitle': 'Safe & Sound Protocol in Adults With Trauma and SUD', 'organization': {'class': 'OTHER', 'fullName': 'Caron Treatment Centers'}, 'officialTitle': 'The Effect of the Safe and Sound Protocol on Emotional Regulation in Traumatized Adults With Substance Use Disorders', 'orgStudyIdInfo': {'id': 'Caron002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active SSP', 'description': 'Participants will engage with the SSP for a minimum of 3 hours and a maximum of 5 hours over the course of seven days.', 'interventionNames': ['Device: Safe and Sound Protocol']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham SSP', 'description': 'Participants will engage with the SSP for a minimum of 3 hours and a maximum of 5 hours over the course of seven days. The sham protocol will deliver unfiltered music.', 'interventionNames': ['Device: Safe and Sound Protocol']}], 'interventions': [{'name': 'Safe and Sound Protocol', 'type': 'DEVICE', 'otherNames': ['SSP'], 'description': 'Participants will complete a series of instruments after consenting to participate and have the SSP uploaded onto their mobile device or tablet. Participants will listen to the SSP for 3 to 5 hours over the course of 7 days. On the eighth day, participants will complete a follow-up set of instruments. The active arm will deliver the actual SSP intervention whereas the sham arm will deliver unfiltered music.', 'armGroupLabels': ['Active SSP', 'Sham SSP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19565', 'city': 'Wernersville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Caron Treatment Centers', 'geoPoint': {'lat': 40.33009, 'lon': -76.0805}}], 'centralContacts': [{'name': 'Erin Deneke, PhD', 'role': 'CONTACT', 'email': 'edeneke@caron.org', 'phone': '6107436242'}, {'name': 'Dean Stankoski, MS', 'role': 'CONTACT', 'email': 'dstankoski@caron.org', 'phone': '6107436224'}], 'overallOfficials': [{'name': 'Erin Deneke, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Caron Treatment Centers'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Caron Treatment Centers', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}