Transdiagnostic Sleep and Anxiety Treatment

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

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders
• Intervention / Treatment: Other: FSET Anxiety and Sleep Treatment; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32306
      • Anxiety and Behavioral Health Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): May 12, 2018
• Study Completion (Actual): May 12, 2018

Study Registration Dates

• First Submitted: September 6, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (Actual): September 10, 2018

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2018.23848

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No