Clinical trial NCT06299657: Intervention for Managing Physical Reactions to Overwhelming Emotions
Official title: Project IMPROVE: Intervention for Managing Physical Reactions to Overwhelming Emotions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Substance Use Disorders
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to receive one of two possible interventions.
Primary purpose: PREVENTION

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.

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 person's 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 (e.g., 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.

Eligibility criteria: 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

Primary outcomes:
measure: Intolerance of Uncertainty-12 Scale
timeFrame: Change will be assessed from baseline to the post-intervention session, occurring four weeks after the baseline session
measure: Anxiety Sensitivity-3 Scale
timeFrame: Change will be assessed from baseline to the post-intervention session, occurring four weeks after the baseline session
measure: PROMIS Anxiety Short Form
timeFrame: Change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up
measure: Timeline Followback
timeFrame: Change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up
measure: Desire for Drug Questionnaire
timeFrame: Change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up
measure: Penn Alcohol Craving Scale
timeFrame: Change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up
measure: Hyperkatifeia Interference Scale - Alcohol Version.
timeFrame: Change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up
measure: Clinical Institute Withdrawal Assessment Alcohol Scale Revised.
timeFrame: Change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up
measure: Hyperkatifeia Interference Scale - Opioid Version.
timeFrame: Change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up
measure: Subjective Opiate Withdrawal Scale
timeFrame: Change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up
measure: NPU Threat Task
timeFrame: Change will be assessed from baseline to the post-intervention session, occurring four weeks after the baseline session
measure: Straw Breathing Avoidance Task
timeFrame: Change will be assessed from baseline to the post-intervention session, occurring four weeks after the baseline session
measure: Emotion Picture Paradigm Task
timeFrame: Change will be assessed from baseline to the post-intervention session, occurring four weeks after the baseline session
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Department of Psychiatry and Behavioral Health
state: Ohio
Study officials:
References: