Intervention for Managing Physical Reactions to Overwhelming Emotions

NCT06299657 | Completed

• 1 other identifier: 2023H0286
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (13)

• Intolerance of Uncertainty-12 Scale

  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.

  Change will be assessed from baseline to the post-intervention session, occurring four weeks after the baseline session

• Anxiety Sensitivity-3 Scale

  Anxiety sensitivity is measured using the 18-item Anxiety Sensitivity Scale. Each item is measured on a 5-point scale from (1) Very Little to (5) Very Much. Higher scores indicate higher anxiety sensitivity with scores ranging from 18 to 90.

  Change will be assessed from baseline to the post-intervention session, occurring four weeks after the baseline session

• PROMIS Anxiety Short Form

  Anxiety symptoms are measured using the 8-item PROMIS Anxiety Short Form. Each item is measured on a 5-point scale from (1) Never to (5) Always. Higher scores indicate increased anxiety symptoms with scores ranging from 8 to 40.

  Change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up

• Timeline Followback

  Substance use is measured using The Timeline Followback (TLFB). The TLFB asks participants to estimate their substance use 7 days to 2 years prior to the interview date.

  Change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up

• Desire for Drug Questionnaire

  Craving for opioids will be measured using the 13-item Desire for Drug Questionnaire. Each item is measured on a 7-point scale from (1) Strongly Disagree to (7) Strongly Agree. High scores indicate increased craving with scores ranging from 13 to 91.

  Change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up

• Penn Alcohol Craving Scale

  Craving for alcohol will be measured using the 5-item Penn Alcohol Craving Scale. Each item is measured on a 7-point scale from 0 to 6. High scores indicate increased craving with scores ranging from 0 to 30.

  Change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up

• Hyperkatifeia Interference Scale - Alcohol Version.

  Withdrawal symptoms for alcohol will be measured using the 7-item Hyperkatifeia Interference Scale - Alcohol Version. Each item is measured on a sliding scale from (0) Did Not Interfere to (100) Completely Interfered. High scores indicated higher interference.

  Change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up

• Clinical Institute Withdrawal Assessment Alcohol Scale Revised.

  Withdrawal symptoms for alcohol will be measured using the clinician-administered Clinical Institute Withdrawal Assessment Alcohol Scale Revised. The measure includes heart rate and blood pressure readings followed by 10 items. Each item is measured on an 8-point scale from 0 to 7.

  Change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up

• Hyperkatifeia Interference Scale - Opioid Version.

  Withdrawal symptoms for opioids will be measured using the 7-item Hyperkatifeia Interference Scale - Opioid Version. Each item is measured on a sliding scale from (0) Did Not Interfere to (100) Completely Interfered. High scores indicated higher interference.

  Change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up

• Subjective Opiate Withdrawal Scale

  Withdrawal symptoms for opioids will be measured using the 16-item Subjective Opiate Withdrawal Scale. Each item is measured on 5-point scale from (0) Not At All to (4) Extremely. High scores indicate increased withdrawal symptoms.

  Change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up

• NPU Threat Task

  Intolerance of uncertainty will be measured using the NPU Threat Task. The task includes a brief, mild electric shock to elicit aversive responding. The task will be a modified version of Grillon and colleagues' No-, Predictable-, Unpredictable -Threat (NPU) startle paradigm11. The NPU-Threat task includes three within-subjects conditions - no shock (N), predictable shock (P), and unpredictable shock (U). Total task time is around 13 minutes.

  Change will be assessed from baseline to the post-intervention session, occurring four weeks after the baseline session

• Straw Breathing Avoidance Task

  Anxiety sensitivity will be measured using the Straw Breathing Avoidance Task. The Straw Breathing Avoidance Task (SB-BAT) is a behavioral task that is used as an index of anxiety sensitivity. The SB-BAT reliably produces bodily sensations mimicking those induced by anxiety by breathing through a coffee straw for two minutes at a rate of 30 breaths per minute, guided by an audio recording. Individuals rate their reaction to that arousal in real-time via self-report ratings, ranging from 0 (no fear) to 100 (extreme fear or panic).

  Change will be assessed from baseline to the post-intervention session, occurring four weeks after the baseline session

• Emotion Picture Paradigm Task

  Neural responses of anxiety sensitivity will be measured using the Emotion Picture Paradigm Task. Individual differences in AS will be assessed using a modified version of the emotion picture paradigm (EPP) during continuous electroencephalography (EEG) recording. The task is uniquely designed to capture neural reactivity to anxiety sensitivity (AS) stimuli. Participants will observe 80 images in four categories: unpleasant, pleasant, neutral, and AS. Images will be presented for 6 seconds, in blocks of 10 images. Blocks of each picture type are presented twice (20 images/type).

  Change will be assessed from baseline to the post-intervention session, occurring four weeks after the baseline session

Study Arms (2)

IMPROVE

EXPERIMENTAL

In this arm, participants will receive the IMPROVE intervention, a clinician-delivered protocol targeting anxiety and uncertainty.

Behavioral: IMPROVE

PHET

ACTIVE COMPARATOR

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.

Behavioral: PHET

Interventions

IMPROVE BEHAVIORAL

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

IMPROVE

PHET BEHAVIORAL

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.

PHET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Ohio State University Department of Psychiatry and Behavioral Health

Columbus, Ohio, 43062, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Raters completing the outcome assessments will be blind to condition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomized to receive one of two possible interventions.

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 8, 2024
• Study Start: March 7, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for at least the next two years. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial individual participant data (IPD) can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Locations

US (1)