Coping Skills Training for Anxiety and Stress

(Blueprint 2 Trial)

Overseen By Allison Johnson

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Duke University

Disqualifiers: Active substance abuse, Severe mental illness, Complex medical needs, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Conditions treated in intensive care units (ICUs) such as the acute respiratory distress syndrome (ARDS), congestive heart failure, COVID pneumonia, and sepsis are common. These can lead to high rates of depression, anxiety, and PTSD that worsen quality of life. Yet there are few effective strategies able to overcome barriers of limited access to mental health care. Even less is known about the experiences of patients from racially and ethnically minoritized populations because of they haven't been included well in past research. To address this problem, the investigators developed Blueprint, a mobile app that coaches people to use adaptive coping skills to self-manage their symptoms. The investigators found that it reduced depression symptoms and improved quality of life compared to placebo. To confirm these promising findings, the investigators are doing a formal test of Blueprint. The investigators will enroll 400 people who received ICU care from 4 hospitals (Duke, UCLA, Colorado, and Oregon). These patients will be randomized to receive either the Blueprint mobile app or a special Education Program mobile app the investigators developed. -both delivered through similar mobile app platforms. Our specific aims are to see which program improves symptoms better across 6 months of follow up. This project addresses national research priorities and could advance the field with a personalizable yet population-focused therapy that could be scaled broadly and efficiently to enhance mental health equity.

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 seems focused on using a mobile app for coping skills, so it's likely you can continue your current medications, but you should confirm with the trial coordinators.

What data supports the effectiveness of the treatment Blueprint, Blueprint Mobile App, Education program, BRAINYAC, Brain Research Apprenticeships in New York at Columbia for anxiety and stress?

Research shows that similar app-based interventions and stress management programs, like the Coping Camp app and the 'Learn Young, Learn Fair' program, have been effective in reducing stress and anxiety and improving coping skills in children and adolescents. ^{1 2 3 4 5}

Is the Coping Skills Training for Anxiety and Stress safe for humans?

The studies reviewed did not report any safety concerns for similar stress and anxiety reduction programs, suggesting they are generally safe for human use. ^{1 5 6 7 8}

How is the Blueprint Mobile App treatment for anxiety and stress different from other treatments?

The Blueprint Mobile App treatment is unique because it combines a mobile app with educational programs to teach coping skills, making it more accessible and interactive compared to traditional therapy sessions. This approach allows users to engage with the treatment at their own pace and convenience, which can be particularly beneficial for those who prefer digital tools over in-person therapy. ^{1 2 5 6 9}

Research Team

Christopher Cox

Principal Investigator

Professor of Medicine

Eligibility Criteria

This trial is for survivors of cardiorespiratory failure who have been in the ICU and are experiencing psychological distress such as depression, anxiety, or PTSD. It's particularly focused on including patients from racially and ethnically minoritized groups.

Inclusion Criteria

My thinking and memory skills are functioning well.

I am 18 years old or older.

I was in intensive care or a similar unit for at least 24 hours recently.

Exclusion Criteria

Active alcohol or drug abuse meeting specific criteria

Anticipated complex medical needs after discharge that would be disruptive to intervention and follow up

Other complex needs anticipated that could interfere with the ability to complete study procedures

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Blueprint mobile app or an Education Program mobile app for 4 weeks

4 weeks

Weekly app sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at 1, 3, and 6 months post-randomization

Treatment Details

Interventions

• Blueprint (Behavioral Intervention)
• Education program (Behavioral Intervention)

Trial Overview The study tests a mobile app called Blueprint that teaches adaptive coping skills to manage symptoms against an Education Program app. Both apps aim to improve mental health over six months, with participants randomly assigned to one of the two.

Participant Groups

Group I: Blueprint adaptive coping skills intervention Experimental Treatment 1 Intervention

This is a unique adaptive coping skills intervention developed over years of research that targets patients hospitalized for cardiorespiratory conditions. Participants will receive 4 weeks of different Blueprint content through a mobile app. Each week's session includes a within-app HADS survey for safety monitoring. A printed or PDF workbook with complementary content and QR links to app videos is provided.

Group II: Education program control Active Control 1 Intervention

This is cardiorespiratory condition-specific content through an iterative process, informed by research on informational needs and past successful education programs. Participants will receive 4 weeks of different 10-minute informational videos unrelated to Blueprint content through a mobile app. Each week's session includes a within-app HADS survey for safety monitoring. A printed or PDF workbook with complementary content and QR links to app videos is provided.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Findings from Research

Camp Cope-A-Lot (CCAL), a computer-assisted cognitive behavioral therapy for anxiety, was found to be effective, with 81% of participants no longer meeting criteria for their anxiety diagnosis after treatment, similar to individual CBT results.

Both CCAL and individual CBT were rated as more acceptable and satisfying by children and parents compared to a control group receiving computer-assisted education, indicating strong potential for using technology in treating youth anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-assisted cognitive behavioral therapy for child anxiety: results of a randomized clinical trial. Khanna, MS., Kendall, PC.[2022]

The Coping Camp app significantly reduced perceived stress, anxiety, and depression among 540 high school students in China over an 11-week intervention, demonstrating its efficacy in managing mental health issues.

Participants found the app to be feasible and acceptable, with high engagement rates (75.4% post-intervention attendance) and positive qualitative feedback, indicating it was viewed as a useful tool for stress management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility, acceptability and efficacy of an app-based intervention (the Coping Camp) in reducing stress among Chinese school adolescents: A cluster randomised controlled trial. Zhou, X., Edirippulige, S., Jones, A., et al.[2023]

An 8-week stress management program significantly reduced the waist-hip ratio in obese Greek children and adolescents, indicating improved body composition.

The intervention also led to better school performance and healthier daily habits among participants, although it did not significantly affect BMI, stress, anxiety, or cortisol levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of a health promotion and stress-management intervention program in a sample of obese children and adolescents. Emmanouil, CC., Pervanidou, P., Charmandari, E., et al.[2019]

The 'Learn Young, Learn Fair' program, implemented in a study with 1,467 fifth and sixth graders across 52 schools, significantly reduced stress symptoms and anxiety, highlighting its efficacy as a universal stress management intervention.

The program improved emotion-focused coping and stress awareness among children, suggesting that school-based prevention programs can effectively address stress-related issues in young populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Learn Young, Learn Fair', a stress management program for fifth and sixth graders: longitudinal results from an experimental study. Kraag, G., Van Breukelen, GJ., Kok, G., et al.[2009]

A 6-week mindfulness-based coping-enhancement program for 208 first-year college students significantly improved their stress management, emotion regulation, and overall well-being, as compared to those who had not yet participated.

The positive effects, including increased mindfulness and resilience, were largely maintained three months after completing the program, indicating its potential long-term benefits for college students.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mindfulness-based promotive coping program improves well-being in college undergraduates. Long, R., Halvorson, M., Lengua, LJ.[2021]

A 5-week video-based slow diaphragmatic breathing curriculum for high school students was found to be feasible and tolerable, with students generally enjoying the exercises despite some challenges with extended exhales.

Preliminary effectiveness assessments showed no significant changes in anxiety levels or physiological stress responses, suggesting that while the program was well-received, it may need adjustments to improve its impact on anxiety management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Slow-Breathing Curriculum for Stress Reduction in High School Students: Lessons Learned From a Feasibility Pilot. Bentley, TGK., Seeber, C., Hightower, E., et al.[2022]

The AST study demonstrated that both the EnergyPod™ and SleepWing™ devices significantly improved mood among high school students, as measured by the Profile of Mood States-Short Form, with a notable reduction in Total Mood Disturbance (p < .001).

Regardless of which device was used, all participants showed significant improvements across various mood subscales, indicating that both devices are effective tools for stress reduction in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adolescent Stress Treatment Study: A Cluster Randomized Trial. Lynch, S., DeBlieck, C., Summers, LC., et al.[2020]

The Positive Technology app, designed for self-management of psychological stress, includes guided relaxation, 3D biofeedback, and stress tracking, showing promise in reducing perceived stress levels based on user feedback from a trial with 32 participants.

Participants reported satisfactory experiences with the app, and those using it with a wrist sensor demonstrated enhanced capabilities for monitoring and managing stress, indicating potential for further development in usability and advanced features.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive technology: a free mobile platform for the self-management of psychological stress. Gaggioli, A., Cipresso, P., Serino, S., et al.[2018]

The Coping Course, a cognitive-behavioral group intervention for incarcerated youth, showed significant improvements in various measures of coping and problem-solving skills among 76 male adolescents, indicating its potential effectiveness.

Participants in the Coping Course demonstrated unique positive changes compared to control groups, suggesting that the intervention specifically contributed to improvements in self-esteem, social adjustment, and knowledge of cognitive-behavioral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot evaluation of the Coping Course: a cognitive-behavioral intervention to enhance coping skills in incarcerated youth. Rohde, P., Jorgensen, JS., Seeley, JR., et al.[2018]

References

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

Computer-assisted cognitive behavioral therapy for child anxiety: results of a randomized clinical trial. [2022]

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

The feasibility, acceptability and efficacy of an app-based intervention (the Coping Camp) in reducing stress among Chinese school adolescents: A cluster randomised controlled trial. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The effectiveness of a health promotion and stress-management intervention program in a sample of obese children and adolescents. [2019]

4. England pubmed.ncbi.nlm.nih.gov

'Learn Young, Learn Fair', a stress management program for fifth and sixth graders: longitudinal results from an experimental study. [2009]

5. England pubmed.ncbi.nlm.nih.gov

A mindfulness-based promotive coping program improves well-being in college undergraduates. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Slow-Breathing Curriculum for Stress Reduction in High School Students: Lessons Learned From a Feasibility Pilot. [2022]

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

Adolescent Stress Treatment Study: A Cluster Randomized Trial. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Positive technology: a free mobile platform for the self-management of psychological stress. [2018]

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

Pilot evaluation of the Coping Course: a cognitive-behavioral intervention to enhance coping skills in incarcerated youth. [2018]