The Fundamental Adaptive Skills Training

ConditionsFundamental Adaptive Skills Training Relaxation and Mindfulness Training

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorFlorida State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

Fundamental Adaptive Skills Training
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
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.

Treatment groups

105 Participants

are divided into 2 treatment groups

Group A: Fundamental Adaptive Skills TrainingExperimental treatment 1 intervention

Group B: Relaxation and Mindfulness TrainingActive comparator 1 intervention

Trial outcomes

Primary outcomes

Acceptability Questionnaire

Self report measure indexing intervention acceptability. Scores range from 0 to 27 with higher scores indicating more favorable acceptability.

Time frame

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.

Time frame

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.

Time frame

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.

Time frame

Baseline through week 4 follow up

Secondary outcomes

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

Time frame

Baseline through week 4 follow up

Other outcomes

Positive and Negative Affect Schedule - Negative Affect Scale

Self report measure indexing negative affectivity. Scores range from 10 to 40 with higher scores indicating worse negative affect.

Time frame

Screening through week 4 follow up

Demographics

Self-report demographic questionnaire

Time frame

Baseline only

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Florida State University

Lead sponsor

Source ClinicalTrials.gov

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