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NCT06299657: IMPROVE
Intervention for Managing Physical Reactions to Overwhelming Emotions
NA trial testing IMPROVE in Anxiety in 20 participants. Completed in 28 February 2025.
28 February 2025
Quick facts
| Lead sponsor | Ohio State University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 20 |
| Start date | 7 March 2024 |
| Primary completion | 28 February 2025 |
| Estimated completion | 28 February 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- IMPROVE
- PHET
Conditions studied
- Anxiety — all drugs for Anxiety →
- Substance Use Disorders — all drugs for Substance Use Disorders →
Sponsor
Ohio State University
Who can join
18 and older, any sex, with Anxiety or Substance Use Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06299657
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of IMPROVE
Trials testing the same drug.
- NCT06885320 — Building Undergraduate Coping & Knowledge for Stress-Resilience · NA · completed
- NCT06576167 — COVID-19 Self-testing IMPROVE · NA · completed
- NCT04598958 — A Multidisciplinary "Integrated Management Team to Improve Maternal-Child Outcomes (IMPROVE)" Intervention to Improve Ma · NA · completed
Other recruiting trials for Anxiety
Currently open trials in the same condition.
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- NCT07522944 — AI-Guided Relaxation for Hemodialysis Anxiety · NA · recruiting
- NCT07466875 — Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients · NA · recruiting
- NCT07425951 — Building Cognitive Behavioural Skills With StoryBooks to Reduce Emotional Difficulties in Kindergarten Years · NA · recruiting
- NCT07473505 — Integrative Bilateral Cervical Sympathetic Blocks for Trauma-Related Symptoms in Special Operations Veterans: A Prospect · recruiting
Other Ohio State University trials
Trials by the same sponsor.
- NCT06542458 — Under-Represented Communities Diagnosed With SCD or MCI Through Tele-Cog · not yet recruiting
- NCT07217548 — Solving Stigma Through POV Simulation: Enhancing Pharmacist Empathy-based Practices With Sickle Cell Disease Patients · NA · enrolling by invitation
- NCT07215221 — Implementation of TBI-RECOVER in Substance Use Treatment · NA · not yet recruiting
- NCT07278427 — Reducing Parental Substance Use and Enhancing Family Resilience Among Rural Families Through Ohio START · recruiting
- NCT07490444 — Metric-Optimized Spectacle Prescriptions for Children With Down Syndrome · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06299657 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ohio State University
- Last refreshed: 11 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06299657.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing