Transdiagnostic Sleep and Anxiety Treatment

Study Overview
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Brief Summary
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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.

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

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Other: FSET Anxiety and Sleep Treatment
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FSET Anxiety and Sleep Treatment<br>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<br>* Computerized anxiety and insomnia intervention.<br>|
| Active Comparator: Control<br>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<br>* Physical health control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Aid Scale | safety aids. Total score (79-445). Higher score indicates worsened symptoms. | Month 1 | 

Secondary Outcome Measures

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