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Transdiagnostic Sleep and Anxiety Treatment

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FSET Anxiety and Sleep Treatment
Control
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Anxiety and Behavioral Health Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FSET Anxiety and Sleep Treatment

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 6, 2018
Last Updated
January 27, 2021
Sponsor
Florida State University
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1. Study Identification

Unique Protocol Identification Number
NCT03664310
Brief Title
Transdiagnostic Sleep and Anxiety Treatment
Official Title
A Pilot Study and Randomized Controlled Trial of Transdiagnostic Sleep and Anxiety Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
May 12, 2018 (Actual)
Study Completion Date
May 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FSET Anxiety and Sleep Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
FSET Anxiety and Sleep Treatment
Intervention Description
Computerized anxiety and insomnia intervention.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Physical health control
Primary Outcome Measure Information:
Title
Safety Aid Scale
Description
safety aids. Total score (79-445). Higher score indicates worsened symptoms.
Time Frame
Month 1
Secondary Outcome Measure Information:
Title
Sleep Related Behavior Questionnaire
Description
sleep safety aids. Total score (32-128). Higher scores indicate worse symptoms.
Time Frame
Month 1
Title
Penn State Worry Questionnaire
Description
worry. Total score (16-80). Higher scores indicate worse symptoms.
Time Frame
Month 1
Title
Dimensional Obsessive Compulsive Scale
Description
OC symptoms. Total score (0-80). Higher scores indicate worse symptoms.
Time Frame
Month 1
Title
Insomnia Severity Index
Description
insomnia. Total score (0-28). Higher scores indicate worse symptoms.
Time Frame
Month 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Anxiety and Behavioral Health Clinic
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States

12. IPD Sharing Statement

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Transdiagnostic Sleep and Anxiety Treatment

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