Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT06865560
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2025-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emotional Awareness and Expression Therapy for Chronic Pain and Opioid Use Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-22', 'studyFirstSubmitDate': '2025-03-05', 'studyFirstSubmitQcDate': '2025-03-05', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean scores on the Treatment Acceptability and Adherence Scale (TAAS) at the post intervention timepoint.', 'timeFrame': 'Approximately day 70', 'description': 'The TAAS is a validated instrument for behavioral interventions. Although no validated cutoff scores exist for this measure, prior research has used an informal cutoff score at the midpoint of the total score (i.e., 35 out of a possible 70) as a measure of moderate acceptability. If the EAET intervention is ineffective, low acceptability may be an explanatory factor. - scores above the midpoint - 35 out of 70 - will denote moderate acceptability of the intervention'}, {'measure': 'Feasibility: Session attendance', 'timeFrame': 'Approximately day 70'}, {'measure': 'Feasibility: Combined completion of in-session and between-session practices', 'timeFrame': 'Approximately day 70'}], 'secondaryOutcomes': [{'measure': 'Change in Brief Pain Inventory (BPI) pain intensity', 'timeFrame': 'Day 1 and up to day 160', 'description': 'The BPI pain intensity is a validated 4-item measure of pain intensity.\n\nChange is measured from day 1 to day 70 AND day 1 to day 160'}, {'measure': 'Change in Pain-related OUD Exacerbation Scale (PrOUD-ES)', 'timeFrame': 'Day 1 and up to day 160', 'description': 'Validated 4-item scale assessing self-reported degree of pain-related OUD symptom exacerbation.\n\nChange is measured from day 1 to day 70 AND day 1 to day 160'}, {'measure': 'Change in Opioid Craving Visual Analog Scale (OC-VAS)', 'timeFrame': 'Day 1 and up to day 160', 'description': 'The OC-VAS is a validated single-item assessment utilizing 0-100 scale reflecting degree of opioid craving.\n\nChange is measured from day 1 to day 70 AND day 1 to day 160'}, {'measure': 'Change in Current Opioid Misuse Measure-Brief (COMM-9)', 'timeFrame': 'Day 1 and up to day 160', 'description': 'The Comm-9 is a validated 9-item self-report measure of opioid misuse.\n\nChange is measured from day 1 to day 70 AND day 1 to day 160'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain', 'Opioid Use Disorder']}, 'descriptionModule': {'briefSummary': 'The study is intended to test whether a group-based Zoom behavioral treatment can help adults with chronic pain and opioid use disorder (OUD) learn effective strategies for reducing pain, disability and other problems that can come with these conditions (such as depression, anxiety, and difficulty managing emotions).', 'detailedDescription': 'Emotional Awareness and Expression Therapy (EAET) is a behavioral therapy that focuses on reducing chronic pain by helping people work on the effects of stress, trauma, and emotions that they have experienced in their lives. It is delivered in group sessions of 5-7 individuals by trained therapists who treat emotions or problems in relationships to reduce chronic pain. Pain decreases through increased recognition and expression of emotions, and learning to feel safe in the presence of emotions.\n\nThe primary aim of the study is to demonstrate the feasibility, acceptability, and preliminary efficacy of the proposed EAET intervention in adults with chronic pain and opioid use disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be able to read, write and speak English\n* Have Internet access and audio-visual conferencing capability (e.g., Zoom meetings by phone or computer) in the home\n* Widespread pain and has opioid use disorder (OUD)\n\nExclusion Criteria:\n\n* Diagnosis of autoimmune disease, spinal cord injury, cancer.\n* Currently receiving cognitive-behavioral therapy, EAET, or other psychological therapies for pain\n* Open litigation regarding chronic pain in the past 1 year, as assessed in preliminary study screening.\n* Inability to provide informed consent and complete study procedures (e.g., indications of suspected major cognitive impairment via observations of study staff during consenting) that would preclude comprehension or participation in study protocols.\n* Pregnant or breastfeeding\n* Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators.'}, 'identificationModule': {'nctId': 'NCT06865560', 'briefTitle': 'Emotional Awareness and Expression Therapy for Chronic Pain and Opioid Use Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Emotional Awareness and Expression Therapy for Chronic Pain and Opioid Use Disorder - A Pilot Study', 'orgStudyIdInfo': {'id': 'HUM00266504'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Emotional Awareness and Expression Therapy (EAET)', 'description': 'Adults with chronic pain and mild to moderate opioid use disorder (OUD).', 'interventionNames': ['Behavioral: Emotional Awareness and Expression Therapy (EAET)']}], 'interventions': [{'name': 'Emotional Awareness and Expression Therapy (EAET)', 'type': 'BEHAVIORAL', 'description': 'A validated, 8-week, group-based telehealth-based behavioral intervention for chronic pain. Session content will include pain neuroscience education, emotion-focused expressive writing, in-vivo emotional expression practices, self-compassion and forgiveness exercises, and assertive communication strategies. Participants will also be provided handouts and pre-recorded guided imagery and cognitive exercises that they can use to facilitate between-session practices.', 'armGroupLabels': ['Emotional Awareness and Expression Therapy (EAET)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joseph Long', 'role': 'CONTACT', 'email': 'josephlo@med.umich.edu', 'phone': '734-763-0108'}, {'name': 'Sana Shaikh', 'role': 'CONTACT', 'email': 'skazi@med.umich.edu', 'phone': '734-763-5226'}, {'name': 'John Sturgeon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'centralContacts': [{'name': 'Joseph Long', 'role': 'CONTACT', 'email': 'josephlo@med.umich.edu', 'phone': '734-763-0108'}, {'name': 'Sana Shaikh', 'role': 'CONTACT', 'email': 'skazi@med.umich.edu', 'phone': '734-763-5226'}], 'overallOfficials': [{'name': 'John Sturgeon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor of Anesthesiology', 'investigatorFullName': 'John Sturgeon', 'investigatorAffiliation': 'University of Michigan'}}}}