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Clinical Trials/NCT03664310
NCT03664310
Completed
Not Applicable

A Pilot Study and Randomized Controlled Trial of Transdiagnostic Sleep and Anxiety Treatment

Florida State University1 site in 1 country61 target enrollmentAugust 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety Disorders
Sponsor
Florida State University
Enrollment
61
Locations
1
Primary Endpoint
Safety Aid Scale
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2017
End Date
May 12, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Norman Schmidt

Professor

Florida State University

Eligibility Criteria

Inclusion Criteria

  • 1 SD above the mean in anxiety and insomnia symptoms
  • Interest in improving anxiety and sleep

Exclusion Criteria

  • Participating in another clinical trial

Outcomes

Primary Outcomes

Safety Aid Scale

Time Frame: Month 1

safety aids. Total score (79-445). Higher score indicates worsened symptoms.

Secondary Outcomes

  • Sleep Related Behavior Questionnaire(Month 1)
  • Penn State Worry Questionnaire(Month 1)
  • Dimensional Obsessive Compulsive Scale(Month 1)
  • Insomnia Severity Index(Month 1)

Study Sites (1)

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