COMPLETED

Intervention for Managing Physical Reactions to Overwhelming Emotions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Project IMPROVE: Intervention for Managing Physical Reactions to Overwhelming Emotions

Quick Facts

Study Start:2024-03-07
Study Completion:2025-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06299657

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

Ohio State University Department of Psychiatry and Behavioral Health
Columbus, Ohio, 43062
United States

Collaborators and Investigators

Sponsor: Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-07
Study Completion Date2025-02-28

Study Record Updates

Study Start Date2024-03-07
Study Completion Date2025-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Anxiety
  • Substance Use Disorders