- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06597032
The Resilience Challenge: Fostering Emotional Resilience During a Time of National Stress (FERN)
The Resilience Challenge: FERN (Fostering Emotional Resilience During a Time of National Stress)
The goal of this clinical trial is to examine the effects of an online positive psychological intervention on positive emotion, anxiety, depression, feelings of social isolation, sleep disturbance and a sense of meaning and purpose in the general public. The main question it aims to answer is:
Will the practice of positive emotion skills via a self-guided online platform reduce feelings of anxiety, depression, social isolation, and sleep disturbance, as well as increase well-being, positive emotion, a sense of meaning and purpose, life satisfaction, and general self-efficacy?
Participants will take part in an online positive psychological skill learning intervention for 6-8 weeks. Prior to beginning, immediately after, and 4 weeks after, participants will fill out measures of their wellbeing.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 06011
- Northwestern University Feinberg School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Over 18 years old, Access to device connected to the internet
Exclusion Criteria:
- Under 18 years old
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Resilience Challenge
The Resilience Challenge Study is an online program containing a series of positive emotion skills for individuals experiencing stress and distress during their everyday life.
The online program specifically targets positive emotion and offers an array of skills in a self-guided online delivery platform.
Participants will, over the course of 6-8 weeks, access weekly skill lessons, daily homework, and daily emotion reporting.
The skill lessons will include: positive events, savoring, gratitude, everyday mindfulness, mindfulness meditation, positive reappraisal, self-compassion, personal strengths, and attainable goals.
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We previously have tested this online program in people facing health- and work-related stressors (e.g., dementia caregivers, healthcare workers), and in 2020 we enrolled adults in a test of the online program to support coping with the stress of the COVID pandemic.
This intervention has been tailored for a widespread, public audience (e.g., we have added a few other safety measures including limits on public forum posting and have clarified wording on some of the intervention content to make it clearer and easier to understand).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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PROMIS Positive Affect CAT
Time Frame: At baseline, after completion of 6-8 week intervention, and 4 weeks later
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At baseline, after completion of 6-8 week intervention, and 4 weeks later
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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PROMIS Depression CAT
Time Frame: At baseline, after completion of 6-8 week intervention, and 4 weeks later
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At baseline, after completion of 6-8 week intervention, and 4 weeks later
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PROMIS Anxiety CAT
Time Frame: At baseline, after completion of 6-8 week intervention, and 4 weeks later
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At baseline, after completion of 6-8 week intervention, and 4 weeks later
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PROMIS Meaning and Purpose CAT
Time Frame: At baseline, after completion of 6-8 week intervention, and 4 weeks later
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At baseline, after completion of 6-8 week intervention, and 4 weeks later
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PROMIS Social Isolation CAT
Time Frame: At baseline, after completion of 6-8 week intervention, and 4 weeks later
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At baseline, after completion of 6-8 week intervention, and 4 weeks later
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PROMIS Sleep Disturbance CAT
Time Frame: At baseline, after completion of 6-8 week intervention, and 4 weeks later
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At baseline, after completion of 6-8 week intervention, and 4 weeks later
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PROMIS General Self-Efficacy CAT
Time Frame: At baseline, after completion of 6-8 week intervention, and 4 weeks later
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At baseline, after completion of 6-8 week intervention, and 4 weeks later
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PROMIS General Life Satisfaction CAT
Time Frame: At baseline, after completion of 6-8 week intervention, and 4 weeks later
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At baseline, after completion of 6-8 week intervention, and 4 weeks later
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Judith T Moskowitz, Northwestern University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STU00222090
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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