An interventional study of FSET Anxiety and Sleep Treatment and Control in Anxiety Disorders, sponsored by Florida State University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-01.
Sponsored by Florida State University · Not applicable, Interventional, and Treatment
Background: Anxiety and insomnia disorders are two of the most common and costly mental health conditions. These disorders are frequently comorbid, but current treatment approaches do not target both. To streamline treatment for these commonly comorbid conditions, a novel, computerized intervention was developed targeting a transdiagnostic factor, safety aids, which are cognitive or behavioral strategies individuals use to cope with distress associated with anxiety or insomnia, that paradoxically exacerbate symptoms. A randomized controlled trial was conducted to determine the acceptability and efficacy of this newly developed intervention. Method: Young adults (N = 61) with elevated anxiety and insomnia symptoms were randomized to receive the anxiety-insomnia intervention or a computerized control condition focused on general physical health behaviors. After the intervention, participants were followed up at one week and one month and completed self-report measures.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 61 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Florida State University is the lead sponsor of 241 studies on the registry; 46 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 9 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The FSET Anxiety and Sleep Treatment (FAST) is a brief, 45-minute computerized intervention that can be accessed by any device connected to the Internet. The majority of the information is delivered via text. The program contains some interactive features such as quizzes, which direct participants to content, personalized to the individual user (for example screenshots, see Figure 2). FAST contains four modules: motivation, psychoeducation, behavioral tools, and behavior change.
Other: FSET Anxiety and Sleep Treatment
The control condition is the Physical Health Education Treatment (PHET) used in several of our laboratory's prior studies (Schmidt, Capron, Raines, \& Allan, 2014). PHET is also a 45-minute computerized intervention, including audio and visual features as well as comprehension quizzes.
Other: Control
Computerized anxiety and insomnia intervention.
Physical health control
Safety Aid Scale
safety aids. Total score (79-445). Higher score indicates worsened symptoms.
Time frame: Month 1
Sleep Related Behavior Questionnaire
sleep safety aids. Total score (32-128). Higher scores indicate worse symptoms.
Time frame: Month 1
Penn State Worry Questionnaire
worry. Total score (16-80). Higher scores indicate worse symptoms.
Time frame: Month 1
Dimensional Obsessive Compulsive Scale
OC symptoms. Total score (0-80). Higher scores indicate worse symptoms.
Time frame: Month 1
Insomnia Severity Index
insomnia. Total score (0-28). Higher scores indicate worse symptoms.
Time frame: Month 1
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Florida State University