New Therapy for Anxiety and Substance Use Disorder

(IMPROVE Trial)

Overseen By Sarah Millisor Irvin, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Severe cognitive impairment, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 3 weeks

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the IMPROVE treatment for anxiety and substance use disorder?

Research shows that emotional regulation training can significantly reduce anxiety, stress, and cravings in individuals with substance use disorders, suggesting that similar treatments like IMPROVE may help manage overwhelming emotions and improve outcomes for those with anxiety and substance use issues. ^{1 2 3 4 5}

Is the new therapy for anxiety and substance use disorder safe for humans?

The research articles provided do not contain specific safety data for the new therapy or its related interventions. ^{4 6 7 8 9}

What makes the IMPROVE treatment unique for anxiety and substance use disorder?

The IMPROVE treatment is unique because it focuses on managing physical reactions to overwhelming emotions, which may help individuals better regulate their emotions and reduce anxiety and substance use. This approach is different from traditional treatments that may not specifically target the physical aspects of emotional responses. ^{4 10 11 12 13}

What is the purpose of this trial?

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.

Eligibility Criteria

Adults over 18 with substance use disorder and anxiety, enrolled in Talbot Hall IOP. Must score 13+ on the PROMIS Anxiety Short Form, have smartphone access for assessments, and be able to give informed consent. Excludes those with severe cognitive impairment or conditions like psychosis that prevent full participation.

Inclusion Criteria

I am over 18 years old.

Participants recently enrolled in the Talbot Hall IOP

Participants must have a PROMIS Anxiety Short Form total score of 13 or greater

Exclusion Criteria

I understand the information given to me about the trial.

Participants with a psychiatric or medical condition that would prevent them from providing informed consent or participating in the treatments (e.g., psychosis, mania, acute intoxication)

Participants with no or limited access to a smartphone compatible with the EMA application

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessment

Participants complete a baseline assessment of mood, substance use, and psychophysiology

1 day

1 visit (in-person)

Ecological Momentary Assessment (EMA)

Participants complete ecological momentary assessments via smartphone technology 4 times a day for 28 days

4 weeks

Treatment

Participants receive one 45 minute - 1 hour intervention each week for 3 weeks, either IMPROVE or PHET

3 weeks

3 visits (in-person)

Post-Intervention Assessment

Participants complete a post-intervention assessment that mirrors the baseline assessment

1 day

1 visit (in-person)

Follow-up

Participants complete follow-up surveys 1- and 3-months post intervention

3 months

Treatment Details

Interventions

• Intervention for Managing Physical Reactions to Overwhelming Emotions
• Physical Health Education Treatment

Trial Overview The trial tests a CBT-based intervention (IMPROVE) against a control (PHET) for managing emotions in people with substance use disorders. Participants are randomly assigned to one of the treatments and assessed via smartphone technology before, during, and up to three months after the interventions.

Participant Groups

Group I: IMPROVE Experimental Treatment 1 Intervention

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

Group II: PHET Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Findings from Research

Emotional regulation training significantly reduced levels of depression, anxiety, and stress in 30 patients with alcohol dependence after a 13-day intervention, with results showing a statistically significant difference at p<0.001.

The study indicates that emotional regulation training is an effective method for helping individuals with alcohol dependence manage negative emotions, which are often linked to relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of emotional regulation training on depression, anxiety and stress among the patients with alcohol dependence admitted in selected de-addiction centers at south India. Pressy Dallia, CC., Sujatha, V., Nalini, S.[2020]

In a study of 138 Veterans undergoing residential treatment for substance use disorders, improvements in emotion regulation during treatment were linked to reduced substance use risk factors after discharge.

Specific difficulties in emotion regulation, such as low emotional clarity and impulse control issues, were found to predict future admissions to withdrawal management services, highlighting the importance of addressing these skills in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emotion Dysregulation and Substance Use Risk and Protective Factors among Veterans in Residential Treatment. Byllesby, BM., Haney, AM., Asamsama, OH.[2023]

In a controlled trial with patients undergoing intensive treatment for cocaine dependence, those who engaged in written emotional expression experienced significant changes in blood pressure and mood, suggesting it may promote active coping strategies.

At follow-up, participants who practiced written emotional expression reported lower cravings for cocaine and were less likely to self-report cocaine use, indicating a potential therapeutic benefit in their recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Written emotional expression during recovery from cocaine dependence: group and individual differences in craving intensity. Grasing, K., Mathur, D., Desouza, C.[2015]

In a pilot study with 29 college students who are problem drinkers and have complex trauma histories, both standard Cognitive Behavior Therapy (CBT) and an enhanced version with emotion regulation skills led to significant reductions in drinking behaviors and PTSD symptoms after eight sessions.

The enhanced CBT with emotion regulation skills resulted in greater reductions in complex PTSD symptoms and a medium/large effect size in reducing alcohol use, suggesting that this approach may be more effective for individuals with trauma histories.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emotion Regulation Enhancement of Cognitive Behavior Therapy for College Student Problem Drinkers: A Pilot Randomized Controlled Trial. Ford, JD., Grasso, DJ., Levine, J., et al.[2023]

Emotion regulation group therapy (ERGT) significantly improved marital satisfaction and reduced craving in patients with substance use disorders, as shown by increased scores in the Dyadic Adjustment Scale and decreased scores in the Craving Beliefs Questionnaire after treatment.

The study involved 30 patients and demonstrated that ERGT enhanced emotional regulation skills, leading to better overall emotional management compared to the treatment as usual (TAU) group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Emotion Regulation Group Therapy on Craving, Emotion Problems, and Marital Satisfaction in Patients with Substance Use Disorders: A Randomized Clinical Trial. Zargar, F., Bagheri, N., Tarrahi, MJ., et al.[2020]

In a study of 120 patients with PTSD in a residential substance treatment program, difficulties in emotion regulation and anxiety sensitivity were found to interactively predict the severity of PTSD symptoms.

The findings suggest that individuals with high difficulties in emotion regulation experience severe PTSD symptoms regardless of their anxiety sensitivity, indicating that addressing emotion regulation may be crucial for improving treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive Effects of Anxiety Sensitivity and Difficulties in Emotion Regulation: An Examination among Individuals in Residential Substance Use Treatment with Comorbid Posttraumatic Stress Disorder. Sippel, LM., Jones, RE., Bordieri, MJ., et al.[2019]

In a study of 217 women undergoing treatment for substance use disorder, respiratory sinus arrhythmia (RSA) was found to be significantly correlated with interoceptive awareness, suggesting it may serve as a physiological index of emotion regulation.

The research highlights the potential for using RSA as a biomarker in clinical settings to identify individuals who may benefit from targeted treatments that enhance interoceptive awareness and improve emotion regulation skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological and Autonomic Correlates of Emotion Dysregulation among Women in Substance Use Disorder Treatment. Price, CJ., Crowell, SE., Pike, KC., et al.[2020]

In a study of 53 female outpatients with substance use disorder (SUD) and posttraumatic stress disorder (PTSD), those who attended at least six sessions of the Seeking Safety therapy showed medium to large improvements in PTSD symptoms and general mental health by the end of treatment, with these benefits maintained at a three-month follow-up.

While significant improvements in alcohol use were only observed at follow-up, the findings suggest that Seeking Safety can be an effective integrated therapy for women dealing with both SUD and PTSD, despite the study's limitations such as the absence of a control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of Seeking Safety in a Sample of German Women Outpatients with Substance Dependence and Posttraumatic Stress Disorder. Kaiser, D., Grundmann, J., Schulze, C., et al.[2015]

The study used fMRI to identify specific brain regions activated during emotional distress in eight healthy volunteers, highlighting the involvement of circuits including the medial prefrontal cortex and anterior cingulate.

These findings suggest that targeted neural circuits play a crucial role in how we experience and regulate emotional stress, providing a method for further research in both healthy individuals and those with psychiatric disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural circuits underlying emotional distress in humans. Sinha, R., Lacadie, C., Skudlarski, P., et al.[2019]

Anxiety and substance use disorders frequently occur together, leading to worse outcomes in both clinical and psychosocial areas compared to when these disorders are not comorbid.

The review discusses assessment methods for screening and treatment planning, as well as evaluates the effectiveness of various psychosocial and biological treatment options for these comorbid conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiety and substance use: layers of complexity. Castle, DJ.[2019]

Anxiety sensitivity (AS) is positively associated with substance use in situations involving negative emotions among individuals with substance use disorders (SUDs), regardless of whether they also have anxiety disorders or not, based on a study of 88 participants.

The study found that AS did not predict substance use in individuals with concurrent mood disorders, suggesting that AS may specifically influence substance use behaviors in those with anxiety-related issues, highlighting the need for targeted treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiety sensitivity and drug or alcohol use in individuals with anxiety and substance use disorders. DeHaas, RA., Calamari, JE., Bair, JP., et al.[2019]

Anxiety disorders, such as generalized anxiety disorder, panic disorder, and post-traumatic stress disorder, are commonly associated with substance use disorders, indicating a complex relationship that can affect treatment outcomes.

Individuals with anxiety disorders have a significantly higher risk of developing nicotine dependence, and smoking is linked to increased anxiety, highlighting the need for integrated treatment approaches for both anxiety and substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Substance use disorders and anxiety: a treatment challenge for social workers. Brady, KT., Haynes, LF., Hartwell, KJ., et al.[2021]

Anxiety disorders are frequently found alongside substance use disorders, impacting treatment outcomes and complicating recovery for affected individuals.

The review highlights effective pharmacological and psychological treatments for anxiety disorders, emphasizing the importance of addressing these comorbid conditions to improve substance use outcomes in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding and treating comorbid anxiety disorders in substance users: review and future directions. Wolitzky-Taylor, K., Operskalski, JT., Ries, R., et al.[2014]

References

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Effect of emotional regulation training on depression, anxiety and stress among the patients with alcohol dependence admitted in selected de-addiction centers at south India. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Emotion Dysregulation and Substance Use Risk and Protective Factors among Veterans in Residential Treatment. [2023]

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Written emotional expression during recovery from cocaine dependence: group and individual differences in craving intensity. [2015]

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Emotion Regulation Enhancement of Cognitive Behavior Therapy for College Student Problem Drinkers: A Pilot Randomized Controlled Trial. [2023]

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Effectiveness of Emotion Regulation Group Therapy on Craving, Emotion Problems, and Marital Satisfaction in Patients with Substance Use Disorders: A Randomized Clinical Trial. [2020]

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Interactive Effects of Anxiety Sensitivity and Difficulties in Emotion Regulation: An Examination among Individuals in Residential Substance Use Treatment with Comorbid Posttraumatic Stress Disorder. [2019]

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Psychological and Autonomic Correlates of Emotion Dysregulation among Women in Substance Use Disorder Treatment. [2020]

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A Pilot Study of Seeking Safety in a Sample of German Women Outpatients with Substance Dependence and Posttraumatic Stress Disorder. [2015]

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Neural circuits underlying emotional distress in humans. [2019]

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Anxiety and substance use: layers of complexity. [2019]

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Anxiety sensitivity and drug or alcohol use in individuals with anxiety and substance use disorders. [2019]

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Substance use disorders and anxiety: a treatment challenge for social workers. [2021]

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Understanding and treating comorbid anxiety disorders in substance users: review and future directions. [2014]