Anxiety Management for Anxiety Disorders

(PACER Trial)

Not currently recruiting at 4 trial locations

Overseen By Paul Musey Jr., MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Psychosis, Schizophrenia, Suicidal ideation, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8-10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which of three treatments best manages anxiety in individuals who recently visited an emergency department with chest pain but were not diagnosed with a heart problem. The treatments compared include an online self-administered anxiety management program with peer support, therapist-led cognitive behavioral therapy (CBT) through telehealth, and enhanced primary care follow-up. Individuals who have experienced chest pain, have moderate to severe anxiety, and are expected to be released from the emergency department within 24 hours might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative anxiety treatments and contribute to valuable research.

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 has shown that the Online Self-Administered Anxiety Management Program, combined with peer support, is generally easy to use. Studies have found that digital programs like this are usually safe, with few reports of negative effects. Many participants find these programs helpful for managing anxiety.

Therapist-Administered Cognitive Behavioral Therapy (CBT) is also recognized as a safe and effective treatment for anxiety. Most people do not experience major side effects. However, some studies have noted that a few patients might feel more anxious temporarily, and a small number might discontinue therapy. Overall, CBT is considered a top treatment with a strong record of safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for anxiety disorders because they offer new ways to tackle the condition. The Online Self-Administered Anxiety Management Program, combined with Peer Support Guidance, allows people to manage their anxiety from the comfort of their home, making it more accessible and flexible than traditional face-to-face therapy. This program also includes peer support, which can provide additional encouragement and accountability. Meanwhile, the Therapist-Administered Cognitive Behavioral Therapy is delivered via telehealth, offering the convenience of virtual sessions while still providing personalized, professional guidance. Both methods expand access to effective anxiety treatment, catering to individuals who may not have the means or time to attend in-person therapy sessions.

What evidence suggests that this trial's treatments could be effective for anxiety disorders?

Research has shown that online cognitive behavioral therapy (CBT) programs, especially when combined with peer support, can greatly reduce anxiety symptoms. These programs are user-friendly and help individuals manage anxiety through structured, self-guided sessions. Studies highlight that peer support enhances these programs by providing encouragement and shared experiences. Participants in this trial may receive the Online Self-Administered Anxiety Management Program plus Peer Support Guidance.

Therapist-led cognitive behavioral therapy (CBT) is another treatment option in this trial and is also highly effective for treating anxiety. Research indicates that up to 57% of people with generalized anxiety disorder recover within 12 months of starting therapy, demonstrating its long-term effectiveness. Therapist-led sessions offer personalized guidance and have proven more effective than usual treatment methods. Both treatment options in this trial can reduce anxiety, but they offer different levels of interaction and support. ^{2 3 4 5 6}

Who Is on the Research Team?

Paul Musey, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for adults who visited the ER with low-risk chest pain and have moderate to severe anxiety. They must have a certain score on heart risk and anxiety assessments, be expected to leave the ER within 24 hours, and speak English. People admitted as inpatients or with active psychosis, traumatic chest pain, unstable vital signs, homelessness, or inability to follow up are excluded.

Inclusion Criteria

Expected to be discharged from the ED or only undergo observation <24 hours.

Your HEART score is between 0 and 3, which means your risk of heart problems is low.

I am an adult who went to the emergency department within the last week.

Exclusion Criteria

I was discharged from the emergency department more than a week ago.

Your blood pressure and heart rate are not stable, according to your doctor.

Issues likely to affect follow up, including prisoners and homelessness

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to one of three anxiety treatment arms: enhanced primary care coordination, online CBT with peer support, or therapist-led CBT via tele-health

8-10 weeks

Follow-up

Participants are monitored for anxiety symptoms, ED utilization, and other health outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Online Self-Administered Anxiety Management Program plus Peer Support Guidance
• Primary care follow-up
• Therapist-Administered Cognitive Behavioral Therapy

Trial Overview The study compares three treatments for anxiety after experiencing chest pain: therapist-led cognitive behavioral therapy (CBT), standard primary care follow-up, and an online self-help program with peer support. The aim is to see which method works best for reducing anxiety in this setting.

How Is the Trial Designed?

Group I: Primary care follow-up Active Control 1 Intervention

Enhanced primary care coordination

Group II: Online Cognitive Behavioral Therapy Active Control 1 Intervention

Online Self-Administered Anxiety Management Program plus Peer Support Guidance

Group III: Therapist-Administered Cognitive Behavioral Therapy Active Control 1 Intervention

Telehealth 8 one-hour sessions over the course of 8 to 10 weeks

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

A pilot study involving 35 therapists tested different support models after initial training in cognitive-behavioral therapy (CBT) for youth anxiety, finding that all support options (expert streaming, peer consultation, and fact sheet self-study) were equally satisfactory and effective in increasing the use of CBT strategies.

Despite positive feedback on the support programs, there were concerning trends indicating a decline in knowledge and self-reported skills among participants, highlighting the need for ongoing development of effective, low-cost training support options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scalable Options for Extended Skill Building Following Didactic Training in Cognitive-Behavioral Therapy for Anxious Youth: A Pilot Randomized Trial. Chu, BC., Carpenter, AL., Wyszynski, CM., et al.[2018]

A computer-aided self-help clinic effectively increased the number of anxious and depressed patients treated per clinician while reducing the time each patient spent with a clinician, without compromising treatment effectiveness.

Patients showed improvement using one of four computer-aided cognitive behavior therapy (CBT) systems for various anxiety and mood disorders, highlighting the potential for these systems to enhance accessibility and reduce stigma associated with mental health treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-aided CBT self-help for anxiety and depressive disorders: experience of a London clinic and future directions. Gega, L., Marks, I., Mataix-Cols, D.[2022]

Internet-based cognitive-behavioral therapy (CBT) is an effective self-help program that allows patients to receive psychological support via the Internet, making therapy more accessible, especially for those unable to attend traditional sessions.

This form of therapy has shown particular effectiveness in treating conditions like panic disorder, social phobia, and depression, indicating its potential to reach and help a wider range of individuals in need of mental health support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Internet-based cognitive-behavioral therapy in the treatment of psychiatric disorders]. Holmberg, N., Kähkönen, S.[2022]

A 9-week Internet-delivered self-help program combined with group exposure sessions significantly improved social anxiety, general anxiety, depression levels, and quality of life in 64 individuals with social phobia, with a strong effect size of Cohen's d = 0.87.

The treatment effects were not only significant but also maintained at a 1-year follow-up, supporting the effectiveness and sustainability of Internet-based interventions for social anxiety disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based self-help with therapist feedback and in vivo group exposure for social phobia: a randomized controlled trial. Andersson, G., Carlbring, P., Holmström, A., et al.[2022]

Citations

1. researchprotocols.org researchprotocols.org/2017/12/e231/

Direct to Public Peer Support and e-Therapy Program ... Effectiveness: To determine the short-term clinical effectiveness of randomization to BWW versus the Moodzone website on well-being (primary ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10205089/

An Online Community Peer Support Intervention to Reduce ... This study tested the effectiveness of the HOPE peer-led social media intervention on (a) rates of anxiety (b) help-seeking requests for an electronic resource ...

3. withpower.com withpower.com/trial/phase-anxiety-disorders-3-2021-b7427

Anxiety Management for Anxiety Disorders (PACER Trial) Research shows that online cognitive behavioral therapy (CBT) programs, especially when combined with peer support, can effectively reduce anxiety symptoms.

4. mentalhealth.bmj.com mentalhealth.bmj.com/content/28/1/e301379.full

Effectiveness of Self-Help Plus in its digital version ... Our results demonstrated that DWM is a promising intervention for reducing moderate-to-severe anxiety and post-traumatic stress disorder ...

5. jmir.org jmir.org/2005/1/e7/

Usage and Longitudinal Effectiveness of a Web-Based Self ... To examine the use and longitudinal effectiveness of a freely available, 12-session, Web-based, cognitive behavioral therapy (CBT) program for panic disorder ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8685377/

Digital Interventions for Generalized Anxiety Disorder (GAD) We conducted a systematic review and network meta-analysis of randomized controlled trials comparing digital interventions with medication, non-digital ...