Fundamental Adaptive Skills TrainingFASTNCT07140718
The Fundamental Adaptive Skills Training
A study testing Fundamental Adaptive Skills Training and Relaxation and Mindfulness Training in people with Fundamental Adaptive Skills Training and Relaxation and Mindfulness Training, run by Florida State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fundamental Adaptive Skills Training, Relaxation and Mindfulness Training
- What is being tested?
- Fundamental Adaptive Skills Training and Relaxation and Mindfulness Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2025to 5 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
FSU Anxiety and Behavioral Health Clinic
Tallahassee, Florida, 32301
Frederick Schubert T Graduate Student, M.S., 850-645-1766, schubert@psy.fsu.edu
Frederick Schubert T Graduate Student, M.S.
About this study
Official title: 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?
Read more
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.
Read the detailed description
The mental health crisis among college students has intensified in recent years, with rising rates of anxiety, depression, and stress. Despite increased institutional efforts, existing mental health services often remain inaccessible or insufficient. The present study proposes and evaluates the Fundamental Adaptive Skills Training (FAST), a novel, single-session intervention designed to promote mental health resilience in college students. FAST will be developed to target empirically supported mechanisms-sleep and physical activity, anxiety sensitivity, loneliness, and social isolation-each linked to a broad range of emotional disorders. Delivered in a digital, group-based format by trained undergraduate peer facilitators, FAST will be scalable, cost-effective, and engaging. This randomized controlled trial will assess the intervention's acceptability and efficacy in improving targeted mechanisms and reducing symptoms of anxiety, depression, and stress over a four-week follow-up period. 100 participants identified as at-risk based on elevated negative affectivity will be randomly assigned to FAST or an active control condition involving mindfulness and relaxation training (RMT). Primary outcomes include improvements in sleep quality, physical activity, anxiety sensitivity, loneliness, and social isolation from baseline through week two and week four follow-up. Similarly, clinical outcomes will include improvements in anxiety, depression, and stress levels as indicators of broader emotional resilience. Findings will advance the science of developing and implementing accessible, evidence-based mental health interventions and may contribute to a novel, scalable solution for addressing mental health issues in higher education settings.
- Being tested
- Fundamental Adaptive Skills Training, Relaxation and Mindfulness Training
- Keywords
- Transdiagnostic, Digital Mental Health, Resilience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fundamental Adaptive Skills TrainingBehavioural
Also called FAST
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.
Relaxation and Mindfulness TrainingBehavioural
Also called RMT
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.
| Study group | Role | What they receive |
|---|---|---|
| Fundamental Adaptive Skills Training | Experimental | Not described Receives: Behavioral: Fundamental Adaptive Skills Training |
| Relaxation and Mindfulness Training | Active comparator | Not described Receives: Behavioral: Relaxation and Mindfulness Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability Questionnaire
Self report measure indexing intervention acceptability. Scores range from 0 to 27 with higher scores indicating more favorable acceptability.
Measured: Post-intervention through week 4 follow up
Athens Insomnia Scale
8 item self report measure of sleep quality. Scores range from 0 to 24 with higher scores indicating more severe sleep problems.
Measured: Baseline through week 4 follow up
Brief Physical Activity Assessment Tool
2 item self report measure indexing physical activity. Scores range from 0 to 8 with higher scores indicating more frequent engagement in physical activity.
Measured: Baseline through week 4 follow up
Anxiety Sensitivity Index 3
18 item self report measure indexing anxiety sensitivity. Scores range from 0 to 72 with higher scores indicating more severe anxiety sensitivity.
Measured: Baseline through week 4 follow up
UCLA Loneliness 10
10 item self-report measure indexing loneliness. Scores range from 10 to 40 with higher scores indicating more severe loneliness symptoms.
Measured: Baseline through week 4 follow up
PROMIS Anxiety Scale 8a
8 item self report measure of anxiety. Scores range from 8 to 40 with higher scores indicating more severe anxiety symptoms.
Measured: Baseline through week 4 follow up
PROMIS Depression 8b
8 item self report measure indexing depression. Scores range from 8 to 40 with higher scores indicating more severe depression symptoms
Measured: Baseline through week 4 follow up
Perceived Stress Scale
14 item self report measure indexing stress. Scores range from 0 to 56 with higher scores reflecting more severe stress symptoms.
Measured: Baseline through week 4 follow up
Secondary outcomes (1)
Short Form 12
Quality of life self report measure with 12 items. Scores range from 0 to 100 with higher scores indicating better quality of life
Measured: Baseline through week 4 follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2025
- Study start20 Sep 2025
- Primary completion5 May 2027 (estimated)
- Study completion5 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fundamental Adaptive Skills TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norman Schmidt, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140718
- Sponsor's protocol ID
- STUDY00006276
- Acronym
- FAST
- Status last verified
- Jun 2026
- First submitted
- 22 Aug 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting and Evaluating the Fundamental Adaptive Skills Training (FAST): a New Digitally Augmented Single-Session Transdiagnostic Resilience Intervention
- ClinicalTrials.gov ID
- NCT07140718
- Acronym / sponsor ID
- FAST / STUDY00006276
- Keywords
- Transdiagnostic, Digital Mental Health, Resilience
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 5 May 2027 (estimated)
- Study completion
- 5 Jun 2027 (estimated)
- First posted
- 25 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The mental health crisis among college students has intensified in recent years, with rising rates of anxiety, depression, and stress. Despite increased institutional efforts, existing mental health services often remain inaccessible or insufficient. The present study proposes and evaluates the Fundamental Adaptive Skills Training (FAST), a novel, single-session intervention designed to promote mental health resilience in college students. FAST will be developed to target empirically supported mechanisms-sleep and physical activity, anxiety sensitivity, loneliness, and social isolation-each linked to a broad range of emotional disorders. Delivered in a digital, group-based format by trained undergraduate peer facilitators, FAST will be scalable, cost-effective, and engaging. This randomized controlled trial will assess the intervention's acceptability and efficacy in improving targeted mechanisms and reducing symptoms of anxiety, depression, and stress over a four-week follow-up period. 100 participants identified as at-risk based on elevated negative affectivity will be randomly assigned to FAST or an active control condition involving mindfulness and relaxation training (RMT). Primary outcomes include improvements in sleep quality, physical activity, anxiety sensitivity, loneliness, and social isolation from baseline through week two and week four follow-up. Similarly, clinical outcomes will include improvements in anxiety, depression, and stress levels as indicators of broader emotional resilience. Findings will advance the science of developing and implementing accessible, evidence-based mental health interventions and may contribute to a novel, scalable solution for addressing mental health issues in higher education settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fundamental Adaptive Skills Training | Experimental | Behavioral: Fundamental Adaptive Skills Training |
| Relaxation and Mindfulness Training | Active comparator | Behavioral: Relaxation and Mindfulness Training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fundamental Adaptive Skills TrainingAlso: FASTThe 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. | Behavioural | Fundamental Adaptive Skills Training |
| Relaxation and Mindfulness TrainingAlso: RMTThe 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. | Behavioural | Relaxation and Mindfulness Training |
Primary outcome
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.
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.
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.
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.
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.
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.
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
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.
1 secondary outcome
Short Form 12
Time frame: Baseline through week 4 follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fundamental Adaptive Skills Training and Relaxation and Mindfulness Training in people with Fundamental Adaptive Skills Training and Relaxation and Mindfulness Training, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frederick Schubert T Schubert, M.S. (850-645-1766, schubert@psy.fsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability Questionnaire (time frame: Post-intervention through week 4 follow up). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.