The Fundamental Adaptive Skills Training

NCT ID: NCT07140718

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-20
• Study Completion Date: 2026-06-05

Brief 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. 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.

Conditions

Fundamental Adaptive Skills Training; Relaxation and Mindfulness Training

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fundamental Adaptive Skills Training

Group Type: EXPERIMENTAL

Fundamental Adaptive Skills Training

Intervention Type: BEHAVIORAL

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 Training

Group Type: ACTIVE_COMPARATOR

Relaxation and Mindfulness Training

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

FAST; RMT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

Norman Schmidt

Distinguished Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

FSU Anxiety and Behavioral Health Clinic

Tallahassee, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Frederick Schubert T Schubert, M.S.

Role: CONTACT

schubert@psy.fsu.edu

850-645-1766

Facility Contacts

Frederick Schubert T Graduate Student, M.S.

Role: primary

schubert@psy.fsu.edu

850-645-1766

Other Identifiers

STUDY00006276

Identifier Type: -

Identifier Source: org_study_id