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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new therapy for individuals with both anxiety and substance use disorders. By comparing two approaches—one focused on managing anxiety (Intervention for Managing Physical Reactions to Overwhelming Emotions, or IMPROVE) and another on general healthy living (Physical Health Education Treatment, or PHET)—researchers aim to determine which is more effective and user-friendly. The study is open to adults who have recently joined an Intensive Outpatient Program (IOP) for substance use and experience high anxiety levels. Participants will attend three weekly sessions, complete daily smartphone check-ins, and provide feedback over several months to assess changes and improvements. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance treatment options for anxiety and substance use disorders.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the IMPROVE treatment, which aids in anxiety and emotion management, uses methods similar to dialectical behavior therapy (DBT). DBT has proven effective in helping individuals with substance use issues better control their emotions. These treatments are typically easy to handle, with few serious side effects reported in studies.

For the Physical Health Education Treatment (PHET), research indicates that exercise and physical activity can significantly boost mental health and reduce substance cravings. These activities are generally safe and offer many benefits, such as lifting mood and lowering anxiety.

Both treatments aim to enhance mental and physical well-being and have been shown to be safe in similar settings. Participants can generally expect these treatments to be easy to tolerate with minimal risk of negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer innovative ways to manage anxiety and substance use disorder by focusing on emotional regulation. The IMPROVE protocol is unique because it directly targets anxiety and uncertainty through clinician-delivered interventions, offering a focused approach to managing overwhelming emotions. On the other hand, the PHET protocol incorporates a digital component and takes a broad approach, emphasizing overall healthy living without specifically targeting anxiety. These methods provide new avenues for treatment by addressing emotional and behavioral aspects, potentially leading to more effective management of these complex conditions.

What evidence suggests that this trial's treatments could be effective for anxiety and substance use disorder?

Research has shown that the IMPROVE intervention, which participants in this trial may receive, might help reduce anxiety and assist with substance use issues. One study found that people using a similar psychological approach experienced a 20.3% drop in anxiety and a 23% boost in overall wellness, outperforming those who did not receive the treatment. This suggests that managing physical reactions to strong emotions can greatly benefit those with anxiety.

Meanwhile, the Physical Health Education Treatment (PHET) is another treatment option in this trial. Exercise programs, like those included in PHET, have been found to lessen cravings and improve mental health in people with substance use problems. Physical activity links to lower anxiety and depression, making it a helpful part of recovery plans. Both treatments in this trial have shown positive results for anxiety and substance use challenges. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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 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 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]

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]

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]

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]

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]

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