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.|
|ClinicalTrials.gov Identifier: NCT03664310|
Recruitment Status : Active, not recruiting
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Disorders||Other: FSET Anxiety and Sleep Treatment Other: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
Physical health control
- Safety Aid Scale [ Time Frame: Month 1 ]safety aids. Total score (79-445). Higher score indicates worsened symptoms.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03664310
|United States, Florida|
|Anxiety and Behavioral Health Clinic|
|Tallahassee, Florida, United States, 32306|