Intervention for Managing Physical Reactions to Overwhelming Emotions

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.

Conditions

• Anxiety
• Substance Use Disorders

Interventions

BEHAVIORAL

IMPROVE

IMPROVE is an individual manualized intervention. Session1 includes: * psychoeducation focusing on anxiety, its role in contributing to substance use, and the maintaining role of fear of bodily sensations * guided discussion of maladaptive thoughts about bodily sensations related to anxiety * how to challenge bodily sensations cognitively * generating three takeaways about the benign nature of anxiety Session 2 includes: * review of homework * psychoeducation focusing on the role of uncertainty in anxiety and identifying how new information can inform beliefs about uncertainty. * when to challenge thoughts related to uncertainty and when to use acceptance regarding uncertainty. Session 3 includes: * review interoceptive exposure (IE) and behavioral exercises (BE) for progress * revisit beliefs related to cognitive biases * discuss areas where skills can be used moving forward

BEHAVIORAL

PHET

Clinicians will administer PHET using a Powerpoint presentation focused on healthy living habits, including healthy eating, water consumption, and sleep hygiene. Clinicians will guide participants through an exercise using the USDA "food tracker" to plan, record, and monitor nutritional information of meals. PHET also includes a digital program that will include EDUCATION, MY CURRENT MOOD, and BEHAVIORAL ACTIVITY tabs.

Sponsors & Collaborators

• Ohio State University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-03-07

Primary Completion

2025-02-28

Completion

2025-02-28

Countries

• United States

Study Locations