Anxiety Management for Anxiety Disorders

(PACER Trial)

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

375 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this research is to compare the benefits and risks of three anxiety treatments that are pragmatic, graduated in the level of resource intensity, and have demonstrated efficacy and feasibility for real world adoption.

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 treatment Online Self-Administered Anxiety Management Program plus Peer Support Guidance for anxiety disorders?

Research shows that online cognitive behavioral therapy (CBT) programs, especially when combined with peer support, can effectively reduce anxiety symptoms. These programs help people feel more connected and empowered, which can improve their commitment to the treatment and lead to better outcomes. ^{1 2 3 4 5}

Is the Anxiety Management treatment generally safe for humans?

Research on internet-based self-help programs for anxiety, including those with peer support and therapist feedback, suggests they are generally safe for humans. However, patient dropouts and poor adherence to treatment are common issues. ^{3 5 6 7 8}

How does the treatment for anxiety disorders differ from other treatments?

This treatment is unique because it combines an online self-administered anxiety management program with peer support guidance and therapist-administered cognitive behavioral therapy (CBT). It offers a flexible, accessible approach that integrates self-help with professional support, making it suitable for individuals who may not have easy access to traditional therapy. ^{1 9 10 11 12}

Research Team

Paul Musey, MD

Principal Investigator

Indiana University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

A randomized controlled trial evaluating the effect of an internet-based cognitive-behavioral program on anxiety symptoms in a community-based sample of adolescents. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Self-help interventions for anxiety disorders: an overview. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Primary Care Peer-Supported Internet-Mediated Psychological Treatment for Adults With Anxiety Disorders: Mixed Methods Study. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Computer-aided CBT self-help for anxiety and depressive disorders: experience of a London clinic and future directions. [2022]

5. England 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. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Self-help treatment of anxiety disorders: a meta-analysis and meta-regression of effects and potential moderators. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Internet-based self-help with therapist feedback and in vivo group exposure for social phobia: a randomized controlled trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Guided and unguided self-help for social anxiety disorder: randomised controlled trial. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

[Perspective of peer helpers regarding their experience animating a self-treatment program for panic disorders]. [2015]

10. Finland pubmed.ncbi.nlm.nih.gov

[Internet-based cognitive-behavioral therapy in the treatment of psychiatric disorders]. [2022]

11. Canada pubmed.ncbi.nlm.nih.gov

Short-term effectiveness of web-based guided self-help for phobic outpatients: randomized controlled trial. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Linking professional and self-help resources for anxiety management: a community project. [2018]