AnxietyIMPROVENCT06299657
Intervention for Managing Physical Reactions to Overwhelming Emotions
A study testing IMPROVE and PHET in people with Anxiety and Substance Use Disorders, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Substance Use Disorders
- What is being tested?
- IMPROVE and PHET
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusionary Criteria:
Participants will be eligible for enrollment if they:
- recently enrolled in the Talbot Hall IOP
- >18 years old
- PROMIS Anxiety Short Form total score is 13 or greater
Exclusionary Criteria:
- do not pass the Informed Decision-Making Capacity (IDMC) screener, suggesting severe cognitive impairment
- 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)
- no or limited access to a smartphone that is compatible with the EMA application
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Department of Psychiatry and Behavioral Health
Columbus, Ohio, 43062
About this study
Official title: Project IMPROVE: Intervention for Managing Physical Reactions to Overwhelming Emotions
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.
Read the 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.
- Conditions
- Anxiety, Substance Use Disorders
- Being tested
- IMPROVE, PHET
- Medical subject headings
- Anxiety Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMPROVEBehavioural
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
PHETBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| IMPROVE | Experimental | In this arm, participants will receive the IMPROVE intervention, a clinician-delivered protocol targeting anxiety and uncertainty. Receives: 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. Receives: Behavioral: PHET |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Change will be assessed from baseline to the post-intervention session, occurring four weeks after the baseline session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start7 Mar 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to receive one of two possible interventions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Allan, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299657
- Sponsor's protocol ID
- 2023H0286
- Acronym
- IMPROVE
- Status last verified
- Jul 2025
- First submitted
- 1 Mar 2024
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified demographic and clinical data collected as part of this project will be available as raw individual level data for sharing with external researchers working at an institution with a Federalwide Assurance (FWA) for the Protection of Human Subjects. Data will therefore be available for secondary analytic purposes. Names and institutions of persons either given or denied access to data will be tracked by our Administrative Core and will be available upon request from the sponsor. Data will not be available for data sharing until after this project is complete and the primary outcomes are published.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project IMPROVE: Intervention for Managing Physical Reactions to Overwhelming Emotions
- ClinicalTrials.gov ID
- NCT06299657
- Acronym / sponsor ID
- IMPROVE / 2023H0286
- Conditions
- Anxiety, Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive one of two possible interventions.
| Arm | Type | Receives |
|---|---|---|
| IMPROVE | Experimental | Behavioral: IMPROVEIn this arm, participants will receive the IMPROVE intervention, a clinician-delivered protocol targeting anxiety and uncertainty. |
| PHET | Active comparator | Behavioral: PHETIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMPROVEIMPROVE 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 | Behavioural | IMPROVE |
| PHETClinicians 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. | Behavioural | PHET |
Primary outcome
Intolerance of Uncertainty-12 Scale
Time frame: Change will be assessed from baseline to the post-intervention session, occurring four weeks after the baseline session
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.
Anxiety Sensitivity-3 Scale
Time frame: Change will be assessed from baseline to the post-intervention session, occurring four weeks after the baseline session
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.
PROMIS Anxiety Short Form
Time frame: Change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up
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.
Timeline Followback
Time frame: Change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up
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.
Desire for Drug Questionnaire
Time frame: Change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up
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.
Penn Alcohol Craving Scale
Time frame: Change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up
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.
Hyperkatifeia Interference Scale - Alcohol Version.
Time frame: Change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up
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.
Clinical Institute Withdrawal Assessment Alcohol Scale Revised.
Time frame: Change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up
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.
Hyperkatifeia Interference Scale - Opioid Version.
Time frame: Change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up
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.
Subjective Opiate Withdrawal Scale
Time frame: Change will be assessed from baseline to a) 1-month follow-up and b) 3-month follow-up
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.
NPU Threat Task
Time frame: Change will be assessed from baseline to the post-intervention session, occurring four weeks after the baseline session
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.
Straw Breathing Avoidance Task
Time frame: Change will be assessed from baseline to the post-intervention session, occurring four weeks after the baseline session
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).
Emotion Picture Paradigm Task
Time frame: Change will be assessed from baseline to the post-intervention session, occurring four weeks after the baseline session
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: Yes. All de-identified demographic and clinical data collected as part of this project will be available as raw individual level data for sharing with external researchers working at an institution with a Federalwide Assurance (FWA) for the Protection of Human Subjects. Data will therefore be available for secondary analytic purposes. Names and institutions of persons either given or denied access to data will be tracked by our Administrative Core and will be available upon request from the sponsor. Data will not be available for data sharing until after this project is complete and the primary outcomes are published.
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Eating Disorders, Anorexia Nervosa
Recruiting
Modulating Escape Using Focused Ultrasound
Anxiety Disorders
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
RecruitingObservational study
Sensory Profile of People With High Intellectual Potential (HIP)
High Intellectual Potential
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMPROVE and PHET in people with Anxiety and Substance Use Disorders, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intolerance of Uncertainty-12 Scale (time frame: Change will be assessed from baseline to the post-intervention session, occurring four weeks after the baseline session). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025; AzTrials last refreshed its copy on 2 Nov 2026.