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NCT06299657 · ClinicalTrials.gov registry record · NA
Intervention for Managing Physical Reactions to Overwhelming Emotions
A NA study, sponsored by Ohio State University.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT06299657: Completed NA study, sponsored by Ohio State University.
NCT06299657 is a NA study that has completed, run by Ohio State University. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06299657, a NA study, has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Intolerance of uncertainty is measured using the 12-item Intolerance of Uncertainty Scale - Short Form. Each item is measured on a 5-point scale from (1) Not At All Characteristic Of Me to (5) Entirely Characteristic Of Me. Higher scores indicate worse intolerance of uncertainty with scores ranging from 12 to 60.
Interventions
- BEHAVIORAL IMPROVE
- BEHAVIORAL PHET
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-03-07 |
| Est. Completion | 2025-02-28 |
| Phase | NA |
What the finished NCT06299657 record still lists
NCT06299657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which IMPROVE is the first listed.
NCT06299657 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06299657 about?
NCT06299657 is a clinical study titled "Intervention for Managing Physical Reactions to Overwhelming Emotions". 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 ...
What is the current status of trial NCT06299657?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2024-03-07. Estimated completion is 2025-02-28.
What interventions are being tested in trial NCT06299657?
The interventions under investigation include: IMPROVE (BEHAVIORAL), PHET (BEHAVIORAL).
Who is sponsoring clinical trial NCT06299657?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06299657's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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