- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07140718
- Original Trial
The Fundamental Adaptive Skills Training (FAST)
Piloting and Evaluating the Fundamental Adaptive Skills Training (FAST): a New Digitally Augmented Single-Session Transdiagnostic Resilience Intervention
The present study seeks to develop, refine, and test a novel psychological treatment for boosting mental health resilience among college students. This Fundamental Adaptive Skills Training (FAST) will be evaluated in a randomized controlled trial. We will seek to recruit 5 undergraduate students as participants for a pilot phase and 100 undergraduate students for a randomized controlled trial. The primary questions we are seeking to answer in this trial are:
Do participants rate the FAST intervention as acceptable? Does FAST improve sleep quality, physical activity, anxiety sensitivity, loneliness, and social isolation for college students?
Participants will:
Receive the active FAST or a placebo control Relaxation and Mindfulness Training (RMT) and will complete measures at baseline, week 2, and week 4.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Frederick Schubert T Schubert, M.S.
- Phone Number: 850-645-1766
- Email: schubert@psy.fsu.edu
Study Locations
-
-
Florida
-
Tallahassee, Florida, United States, 32301
- Recruiting
- FSU Anxiety and Behavioral Health Clinic
-
Contact:
- Frederick Schubert T Graduate Student, M.S.
- Phone Number: 850-645-1766
- Email: schubert@psy.fsu.edu
-
Principal Investigator:
- Frederick Schubert T Graduate Student, M.S.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18+
- At-risk for emotional disorders as indicated by a PANAS-NA Score >= 20
- Ability to use a computer or smartphone
- Currently enrolled at college/university at the time of study enrollment
Exclusion criteria:
- Adults aged 17 and under
- PANAS-NA Score <= 19
- Inability to use a computer or smartphone
- Not currently enrolled at college/university at the time of study enrollment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Fundamental Adaptive Skills Training
|
The FAST intervention will be approximately 60 minutes in duration.
The video component of FAST, animated using the Vyond software, will be presented via computer or projector.
Pause points and brief interactive exercises will be added throughout the presentation to promote engagement and ensure comprehension of FAST material.
The treatment will be sectioned into thirds: a physical health section focused on sleep hygiene and physical activity, an anxiety sensitivity section dispelling common AS myths, and a social health section.
Each section will contain brief psychoeducation focused on dispelling common myths or promoting adaptive skills use.
Other Names:
|
|
Active Comparator: Relaxation and Mindfulness Training
|
The RMT intervention will be primarily psychoeducational and focused on explaining relaxation methods used in various psychological treatments such as progressive muscle relaxation, guided imagery, and mindfulness-focused breathing exercises.
Interactive relaxation and mindfulness exercises and brief discussions following each relaxation component will be included to control for time spent on interactive exercises in the FAST condition.
The intervention will take approximately 60 minutes.
Tailored to control for the effects of general education, practice exercises, and time spent on the FAST intervention, RMT will be a stronger control in comparison to a waitlist or repeated contact condition.
Like the FAST intervention, this program will also be digitalized to allow for ease-of-administration.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability Questionnaire
Time Frame: Post-intervention through week 4 follow up
|
Self report measure indexing intervention acceptability.
Scores range from 0 to 27 with higher scores indicating more favorable acceptability.
|
Post-intervention through week 4 follow up
|
|
Athens Insomnia Scale
Time Frame: Baseline through week 4 follow up
|
8 item self report measure of sleep quality.
Scores range from 0 to 24 with higher scores indicating more severe sleep problems.
|
Baseline through week 4 follow up
|
|
Brief Physical Activity Assessment Tool
Time Frame: Baseline through week 4 follow up
|
2 item self report measure indexing physical activity.
Scores range from 0 to 8 with higher scores indicating more frequent engagement in physical activity.
|
Baseline through week 4 follow up
|
|
Anxiety Sensitivity Index 3
Time Frame: Baseline through week 4 follow up
|
18 item self report measure indexing anxiety sensitivity.
Scores range from 0 to 72 with higher scores indicating more severe anxiety sensitivity.
|
Baseline through week 4 follow up
|
|
UCLA Loneliness 10
Time Frame: Baseline through week 4 follow up
|
10 item self-report measure indexing loneliness.
Scores range from 10 to 40 with higher scores indicating more severe loneliness symptoms.
|
Baseline through week 4 follow up
|
|
PROMIS Anxiety Scale 8a
Time Frame: Baseline through week 4 follow up
|
8 item self report measure of anxiety.
Scores range from 8 to 40 with higher scores indicating more severe anxiety symptoms.
|
Baseline through week 4 follow up
|
|
PROMIS Depression 8b
Time Frame: Baseline through week 4 follow up
|
8 item self report measure indexing depression.
Scores range from 8 to 40 with higher scores indicating more severe depression symptoms
|
Baseline through week 4 follow up
|
|
Perceived Stress Scale
Time Frame: Baseline through week 4 follow up
|
14 item self report measure indexing stress.
Scores range from 0 to 56 with higher scores reflecting more severe stress symptoms.
|
Baseline through week 4 follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Form 12
Time Frame: Baseline through week 4 follow up
|
Quality of life self report measure with 12 items.
Scores range from 0 to 100 with higher scores indicating better quality of life
|
Baseline through week 4 follow up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positive and Negative Affect Schedule - Negative Affect Scale
Time Frame: Screening through week 4 follow up
|
Self report measure indexing negative affectivity.
Scores range from 10 to 40 with higher scores indicating worse negative affect.
|
Screening through week 4 follow up
|
|
Demographics
Time Frame: Baseline only
|
Self-report demographic questionnaire
|
Baseline only
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- STUDY00006276
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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