Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299657
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-03-01
Brief Title:
Intervention for Managing Physical Reactions to Overwhelming Emotions
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Project IMPROVE Intervention for Managing Physical Reactions to Overwhelming Emotions
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPROVE
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
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
Detailed Description:
Substance use disorders SUDs represent a significant public health problem across the globe Anxiety commonly co-occurs with SUD This is alarming given elevated anxiety is both common and deleterious in people with an SUD and elevated anxiety significantly mitigates a persons ability to complete SUD treatment to reduce substance use and maintain abstinence and to maintain quality of life for those in recovery from SUD Substance misuse and anxiety commonly co-occur due to 1 substance use to cope with anxiety symptoms sensations and triggers uncertainty and 2 heightened negative affective states that are experienced similarly across craving withdrawal anxiety and stress Intensive Outpatient Programs IOPs for substance use offer structured therapeutic services and support to individuals struggling with addiction providing them with the necessary treatment and coping skills while allowing them to continue with their everyday activities However it has been estimated that only 50 of people who enroll in an IOP complete the program and 60 of those who do complete an IOP relapse within the first two years Anxiety poses a significant barrier to successfully addressing substance misuse given
In spite of this there are no empirically supported treatments to reduce cognitive biases common to anxiety and SUDs The investigators have iteratively developed a modular intervention rooted in cognitive behavioral therapy CBT called Intervention for Managing Physical Reactions to Overwhelming Emotions IMPROVE IMPROVE targets anxiety sensitivity AS or fear of anxious arousal and intolerance of uncertainty IU or distress when experiencing uncertainty or ambiguity The next step in development is a pilot acceptability feasibility and usability trial during which the investigators would collect preliminary effect size estimates of subjective and objective markers of AS IU and substance use-related outcomes The investigators propose to conduct a randomized controlled trial comparing IMPROVE to an active control Physical Health Education Treatment PHET in 40 adults enrolled in the IOP at Talbot Hall The Ohio State University Wexner Center
Specific Aims
Aim 1 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 Adults recently enrolled in the Talbot Hall IOP program and reporting elevated anxiety PROMIS Anxiety Short Form total score of 13 or greater will be randomized to IMPROVE n 20 or PHET n 20 Participants will complete a screen multimodal assessment battery and a week of brief surveys throughout the day via ecological momentary assessment EMA to capture baseline emotional distress substance use cravings and withdrawal Participants will then be randomized to a treatment arm both of which include three weeks of face-to-face treatment supplemented by two weeks of mobile app use Participants will complete post-intervention multimodal assessments and in-depth qualitative interviews Finally participants will complete the clinical assessment battery at 1- and 3-month follow-up The investigators will assess whether IMPROVE and PHET meet predefined benchmarks for acceptability feasibility and usability
Aim 2 Probe target engagement and change in clinical outcomes In the context of the randomized controlled trial the investigators will 2a Examine whether IMPROVE reduces subjective and objective AS and IU primary targets and 2b whether changes in AS and IU are associated with changes in anxiety symptoms craving and withdrawal sensations primary outcomes The investigators will also 2c Conduct exploratory analyses that estimate the effects of treatment-related factors eg digital engagement on changes in AS IU and clinical outcomes
Aim 3 Examine attrition rates in IOP In the context of the randomized controlled trial RCT the investigators will 3a Examine whether IMPROVE increases engagement reduces attrition and improves IOP completion rates
Background Rationale
Anxiety and SUD covary highly further anxiety in those with an SUD is associated with increased severity and less likelihood to remain in and benefit from SUD treatment In our own research the investigators have found that two transdiagnostic risk factors for anxiety are also strongly implicated in SUDs Anxiety sensitivity or fear of anxiety sensations and intolerance of uncertainty or distress experienced in the presence of uncertainty or ambiguity not only predict the etiology of anxiety and related disorders but also predict poor substance use outcomes including treatment dropout when enrolled in a SUD program
The investigators have developed a modular CBT-based intervention for anxiety and related emotional distress disorders The investigators have iteratively refined the AS and IU modules used in IMPROVE together and separately across numerous pilot trials in adults Findings from these studies demonstrate that IMPROVE treatment components are 1 rated as highly acceptable and feasible and 2 associated with reductions in anxiety sensitivity intolerance of uncertainty and emotional distress disorders Our pilot data which includes testing the anxiety sensitivity module in a sample of adults receiving medication-assisted therapy for an opioid use disorder OUD demonstrates that IMPROVE is well-positioned for adaptation as a supplemental treatment for individuals enrolled in an IOP
In spite of this there are no empirically supported treatments to reduce cognitive biases common to anxiety and SUDs The investigators have iteratively developed a modular intervention rooted in cognitive behavioral therapy CBT called Intervention for Managing Physical Reactions to Overwhelming Emotions IMPROVE IMPROVE targets anxiety sensitivity AS or fear of anxious arousal and intolerance of uncertainty IU or distress when experiencing uncertainty or ambiguity The next step in development is a pilot acceptability feasibility and usability trial during which the investigators would collect preliminary effect size estimates of subjective and objective markers of AS IU and substance use-related outcomes The investigators propose to conduct a randomized controlled trial comparing IMPROVE to an active control Physical Health Education Treatment PHET in 40 adults enrolled in the IOP at Talbot Hall The Ohio State University Wexner Center
Specific Aims
Aim 1 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 Adults recently enrolled in the Talbot Hall IOP program and reporting elevated anxiety PROMIS Anxiety Short Form total score of 13 or greater will be randomized to IMPROVE n 20 or PHET n 20 Participants will complete a screen multimodal assessment battery and a week of brief surveys throughout the day via ecological momentary assessment EMA to capture baseline emotional distress substance use cravings and withdrawal Participants will then be randomized to a treatment arm both of which include three weeks of face-to-face treatment supplemented by two weeks of mobile app use Participants will complete post-intervention multimodal assessments and in-depth qualitative interviews Finally participants will complete the clinical assessment battery at 1- and 3-month follow-up The investigators will assess whether IMPROVE and PHET meet predefined benchmarks for acceptability feasibility and usability
Aim 2 Probe target engagement and change in clinical outcomes In the context of the randomized controlled trial the investigators will 2a Examine whether IMPROVE reduces subjective and objective AS and IU primary targets and 2b whether changes in AS and IU are associated with changes in anxiety symptoms craving and withdrawal sensations primary outcomes The investigators will also 2c Conduct exploratory analyses that estimate the effects of treatment-related factors eg digital engagement on changes in AS IU and clinical outcomes
Aim 3 Examine attrition rates in IOP In the context of the randomized controlled trial RCT the investigators will 3a Examine whether IMPROVE increases engagement reduces attrition and improves IOP completion rates
Background Rationale
Anxiety and SUD covary highly further anxiety in those with an SUD is associated with increased severity and less likelihood to remain in and benefit from SUD treatment In our own research the investigators have found that two transdiagnostic risk factors for anxiety are also strongly implicated in SUDs Anxiety sensitivity or fear of anxiety sensations and intolerance of uncertainty or distress experienced in the presence of uncertainty or ambiguity not only predict the etiology of anxiety and related disorders but also predict poor substance use outcomes including treatment dropout when enrolled in a SUD program
The investigators have developed a modular CBT-based intervention for anxiety and related emotional distress disorders The investigators have iteratively refined the AS and IU modules used in IMPROVE together and separately across numerous pilot trials in adults Findings from these studies demonstrate that IMPROVE treatment components are 1 rated as highly acceptable and feasible and 2 associated with reductions in anxiety sensitivity intolerance of uncertainty and emotional distress disorders Our pilot data which includes testing the anxiety sensitivity module in a sample of adults receiving medication-assisted therapy for an opioid use disorder OUD demonstrates that IMPROVE is well-positioned for adaptation as a supplemental treatment for individuals enrolled in an IOP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None