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Transdiagnostic Sleep and Anxiety Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03664310
Recruitment Status : Active, not recruiting
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Information provided by (Responsible Party):
Florida State University

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.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Other: FSET Anxiety and Sleep Treatment Other: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Pilot Study and Randomized Controlled Trial of Transdiagnostic Sleep and Anxiety Treatment
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : August 1, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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.
Other: FSET Anxiety and Sleep Treatment
Computerized anxiety and insomnia intervention.

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.
Other: Control
Physical health control

Primary Outcome Measures :
  1. Safety Aid Scale [ Time Frame: Month 1 ]
    safety aids. Total score (79-445). Higher score indicates worsened symptoms.

Secondary Outcome Measures :
  1. Sleep Related Behavior Questionnaire [ Time Frame: Month 1 ]
    sleep safety aids. Total score (32-128). Higher scores indicate worse symptoms.

  2. Penn State Worry Questionnaire [ Time Frame: Month 1 ]
    worry. Total score (16-80). Higher scores indicate worse symptoms.

  3. Dimensional Obsessive Compulsive Scale [ Time Frame: Month 1 ]
    OC symptoms. Total score (0-80). Higher scores indicate worse symptoms.

  4. Insomnia Severity Index [ Time Frame: Month 1 ]
    insomnia. Total score (0-28). Higher scores indicate worse symptoms.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03664310

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United States, Florida
Anxiety and Behavioral Health Clinic
Tallahassee, Florida, United States, 32306
Sponsors and Collaborators
Florida State University

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Responsible Party: Florida State University Identifier: NCT03664310     History of Changes
Other Study ID Numbers: 2018.23848
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders