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Behavioral Intervention

Coping Skills Training for Anxiety and Stress (Blueprint 2 Trial)

N/A

Recruiting

Led By Christopher Cox

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult (age ≥18)

Managed in an ICU or stepdown unit for ≥24 hours during the time inclusion criterion #3 is met

Must not have

Discharge to a location other than independent in a home setting

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 month, 3 months, and 6 months post-randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to address the mental health challenges faced by patients who have been in intensive care units by developing a mobile app called Blueprint. This app helps people manage their symptoms and has been shown to reduce

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves psychological interventions through mobile apps rather than medications, traditional side effects are not expected. However, users may experience discomfort or emotional distress when engaging with their symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

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I do not have a severe heart or lung condition.

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I can fluently speak and understand English or Spanish.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I will be discharged to a place that is not my home.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month, 3 months, and 6 months post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 month, 3 months, and 6 months post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 3 months, and 6 months post-randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hospital Anxiety and Depression Scale (HADS)

Secondary study objectives

EuroQOL-5D visual analog scale (EQ VAS) quality of life measure

Perceived Stress Scale 4-Item survey (PSS-4)

Post-Traumatic Stress Syndrome inventory (PTSS)

Other study objectives

Patient Health Questionnaire 10-Item symptoms scale (PHQ-10)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Blueprint adaptive coping skills interventionExperimental Treatment1 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 controlActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Blueprint

2019

Completed Phase 2

~30

0 / 5Eligibility criteria met