Transdiagnostic Sleep and Anxiety Treatment

Overview

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.

Full Title of Study: “A Pilot Study and Randomized Controlled Trial of Transdiagnostic Sleep and Anxiety Treatment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: May 12, 2018

Interventions

  • Other: FSET Anxiety and Sleep Treatment
    • Computerized anxiety and insomnia intervention.
  • Other: Control
    • Physical health control

Arms, Groups and Cohorts

  • Experimental: FSET Anxiety and Sleep Treatment
    • 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.
  • Active Comparator: Control
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Safety Aid Scale
    • Time Frame: Month 1
    • safety aids. Total score (79-445). Higher score indicates worsened symptoms.

Secondary Measures

  • Sleep Related Behavior Questionnaire
    • Time Frame: Month 1
    • sleep safety aids. Total score (32-128). Higher scores indicate worse symptoms.
  • Penn State Worry Questionnaire
    • Time Frame: Month 1
    • worry. Total score (16-80). Higher scores indicate worse symptoms.
  • Dimensional Obsessive Compulsive Scale
    • Time Frame: Month 1
    • OC symptoms. Total score (0-80). Higher scores indicate worse symptoms.
  • Insomnia Severity Index
    • Time Frame: Month 1
    • insomnia. Total score (0-28). Higher scores indicate worse symptoms.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Florida State University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Norman Schmidt, Professor – Florida State University

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