Transdiagnostic Sleep and Anxiety Treatment

Not Applicable

Completed

• Conditions: Anxiety Disorders
• Interventions: Other: Control; Other: FSET Anxiety and Sleep Treatment

• Registration Number: NCT03664310
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-01
• Primary Completion: 2018-05-12
• Study Completion: 2018-05-12
• Study First Submitted: 2018-09-06
• Study First Submitted QC: 2018-09-07
• Study First Posted: 2018-09-10
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	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.
FSET Anxiety and Sleep Treatment	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Anxiety and Behavioral Health Clinic; 🇺🇸 Tallahassee, Florida, United States