Intervention for managing emotional reactions in people with anxiety and substance use disorders
Project IMPROVE: Intervention for Managing Physical Reactions to Overwhelming Emotions
This study is testing a new program called IMPROVE to see if it can help adults with anxiety and substance use issues feel better while they are in treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06299657 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a new intervention called IMPROVE, designed to help individuals with substance use disorders (SUD) who also experience elevated anxiety. The study will enroll 40 adults currently in an Intensive Outpatient Program (IOP) and will randomly assign them to either the IMPROVE intervention or an active control group receiving physical health education. Participants will undergo baseline assessments and complete ecological momentary assessments via smartphone over a 28-day period to track mood, substance use, and physiological responses. The goal is to assess the feasibility, acceptability, and effectiveness of the intervention in improving clinical outcomes and reducing attrition rates in IOP.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who are enrolled in an IOP for substance use and have elevated anxiety levels.
Not a fit: Patients with severe cognitive impairments or those with psychiatric conditions that prevent informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve treatment outcomes for patients with co-occurring anxiety and substance use disorders.
How similar studies have performed: While there is limited empirical support for similar interventions, the study aims to fill a gap in treatment options for individuals facing both anxiety and substance use disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusionary Criteria: Participants will be eligible for enrollment if they: 1. recently enrolled in the Talbot Hall IOP 2. \>18 years old 3. PROMIS Anxiety Short Form total score is 13 or greater Exclusionary Criteria: 1. do not pass the Informed Decision-Making Capacity (IDMC) screener, suggesting severe cognitive impairment 2. presence of a psychiatric or medical condition that would prevent them from providing informed consent or from participating in the treatments (e.g., psychosis, mania, acute intoxication) 3. no or limited access to a smartphone that is compatible with the EMA application
Where this trial is running
Columbus, Ohio
- Ohio State University Department of Psychiatry and Behavioral Health — Columbus, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Nicholas Allan, PhD
- Email: nicholas.allan@osumc.edu
- Phone: 614-814-1299
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.