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Behavioral Intervention

IMPROVE for Anxiety (IMPROVE Trial)

N/A
Waitlist Available
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up
Awards & highlights

IMPROVE Trial Summary

This trial will test a new therapy for individuals with substance use disorder and anxiety who are currently enrolled in an Intensive Outpatient Program (IOP). The study will enroll 40 adults and randomly assign

Who is the study for?
Adults over 18 with substance use disorder and anxiety, enrolled in Talbot Hall IOP. Must score 13+ on the PROMIS Anxiety Short Form, have smartphone access for assessments, and be able to give informed consent. Excludes those with severe cognitive impairment or conditions like psychosis that prevent full participation.Check my eligibility
What is being tested?
The trial tests a CBT-based intervention (IMPROVE) against a control (PHET) for managing emotions in people with substance use disorders. Participants are randomly assigned to one of the treatments and assessed via smartphone technology before, during, and up to three months after the interventions.See study design
What are the potential side effects?
Since this is a psychological intervention involving education and therapy sessions rather than medication, typical medical side effects are not expected. However, participants may experience emotional discomfort or distress as they address their anxiety and substance use issues.

IMPROVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anxiety Sensitivity-3 Scale
Clinical Institute Withdrawal Assessment Alcohol Scale Revised.
Desire for Drug Questionnaire
+10 more

IMPROVE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: IMPROVEExperimental Treatment1 Intervention
In this arm, participants will receive the IMPROVE intervention, a clinician-delivered protocol targeting anxiety and uncertainty.
Group II: PHETActive Control1 Intervention
In this arm, participants will receive a clinician-delivered protocol with a digital component, called PHET. PHET focuses on healthy living more broadly and does not include information about anxiety or uncertainty.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IMPROVE
2016
N/A
~1010

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
829 Previous Clinical Trials
505,703 Total Patients Enrolled
14 Trials studying Anxiety
2,626 Patients Enrolled for Anxiety

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this clinical trial currently open?

"As per information on clinicaltrials.gov, at present, this particular trial is not actively seeking participants. The trial was first listed on 3/1/2024 and the most recent update was made on 3/6/2024. Despite this study currently being closed for recruitment, there are a total of 781 ongoing trials that are accepting new enrollees."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Intervention for Managing Physical Reactions to Overwhelming Emotions
Nicholas Allan 2024. "Intervention for Managing Physical Reactions to Overwhelming Emotions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06299657.
~27 spots leftby Mar 2026
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