Transdiagnostic Sleep and Anxiety Treatment

NCT03664310 | Completed

• 1 other identifier: 2018.23848
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders

Outcome Measures

Primary Outcomes (1)

• Safety Aid Scale

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

  Month 1

Secondary Outcomes (4)

• Sleep Related Behavior Questionnaire

  Month 1

• Penn State Worry Questionnaire

  Month 1

• Dimensional Obsessive Compulsive Scale

  Month 1

• Insomnia Severity Index

  Month 1

Study Arms (2)

FSET Anxiety and Sleep Treatment

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

FSET Anxiety and Sleep Treatment OTHER

Computerized anxiety and insomnia intervention.

FSET Anxiety and Sleep Treatment

Control OTHER

Physical health control

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• SD above the mean in anxiety and insomnia symptoms
• Interest in improving anxiety and sleep

You may not qualify if:

• Participating in another clinical trial

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Anxiety and Behavioral Health Clinic

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 10, 2018
• Study Start: August 1, 2017
• Primary Completion: May 12, 2018
• Study Completion: May 12, 2018
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

US (1)