Transdiagnostic Sleep and Anxiety Treatment

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03664310
• Other study ID #: 2018.23848
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: May 12, 2018

Study information

• Verified date: January 2021
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 12, 2018
• Est. primary completion date: May 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Other:
• FSET Anxiety and Sleep Treatment
Computerized anxiety and insomnia intervention.
• Control
Physical health control

Locations

Country	Name	City	State
United States	Anxiety and Behavioral Health Clinic	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Aid Scale	safety aids. Total score (79-445). Higher score indicates worsened symptoms.	Month 1
Secondary	Sleep Related Behavior Questionnaire	sleep safety aids. Total score (32-128). Higher scores indicate worse symptoms.	Month 1
Secondary	Penn State Worry Questionnaire	worry. Total score (16-80). Higher scores indicate worse symptoms.	Month 1
Secondary	Dimensional Obsessive Compulsive Scale	OC symptoms. Total score (0-80). Higher scores indicate worse symptoms.	Month 1
Secondary	Insomnia Severity Index	insomnia. Total score (0-28). Higher scores indicate worse symptoms.	Month 1