protocolSection identificationModule nctId: NCT06299657, orgStudyIdInfo id: 2023H0286, briefTitle: Intervention for Managing Physical Reactions to Overwhelming Emotions, acronym: IMPROVE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Ohio State University, class: OTHER, descriptionModule briefSummary: The clinical trial aims to conduct a feasibility, acceptability, and usability clinical trial of a modular CBT-based and technologically enhanced intervention for people with an SUD and recently enrolled in IOP, probe target engagement and change in clinical outcomes, and examine attrition rates in IOP.This study will enroll 40 adults who are currently enrolled in IOP, have a substance use disorder, and experience elevated anxiety. 20 individuals will be randomized to the experimental intervention, "Intervention for Managing Physical Reactions to Overwhelming Emotions" (IMPROVE), and 20 individuals will be randomized to the active control group, "Physical Health Education Treatment" (PHET).Participants will be asked to complete a baseline assessment of mood, substance use, and psychophysiology. Participants will then completed ecological momentary assessments (EMA) via smartphone technology 4 times a day for \~ 28 days (the day following the baseline assessment until the 3rd intervention session). Participants will complete one 45 minute - 1 hour intervention each week for 3 weeks (either the IMPROVE or PHET intervention, pending randomization). Following the last intervention session, participants will return to the lab to complete a post-intervention assessment that mirrors the baseline assessment and then complete follow-up surveys 1- and 3-months post intervention., conditionsModule conditions: Anxiety, conditions: Substance Use Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomized to receive one of two possible interventions., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Raters completing the outcome assessments will be blind to condition., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: IMPROVE, interventions name: PHET, outcomesModule primaryOutcomes measure: Intolerance of Uncertainty-12 Scale, primaryOutcomes measure: Anxiety Sensitivity-3 Scale, primaryOutcomes measure: PROMIS Anxiety Short Form, primaryOutcomes measure: Timeline Followback, primaryOutcomes measure: Desire for Drug Questionnaire, primaryOutcomes measure: Penn Alcohol Craving Scale, primaryOutcomes measure: Hyperkatifeia Interference Scale - Alcohol Version., primaryOutcomes measure: Clinical Institute Withdrawal Assessment Alcohol Scale Revised., primaryOutcomes measure: Hyperkatifeia Interference Scale - Opioid Version., primaryOutcomes measure: Subjective Opiate Withdrawal Scale, primaryOutcomes measure: NPU Threat Task, primaryOutcomes measure: Straw Breathing Avoidance Task, primaryOutcomes measure: Emotion Picture Paradigm Task, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ohio State University Department of Psychiatry and Behavioral Health, city: Columbus, state: Ohio, zip: 43062, country: United States, contacts name: Nicholas P Allan, PhD, role: CONTACT, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False