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OpenTrials
Completed

NCT Number: NCT03664310

Transdiagnostic Sleep and Anxiety Treatment

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anxiety and Behavioral Health Clinic

Tallahassee, Florida, 32306, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FSET Anxiety and Sleep Treatment

Other

Computerized anxiety and insomnia intervention.

Control

Other

Physical health control

Primary outcomes

  1. Safety Aid Scale

    Time frame: Month 1

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

Secondary outcomes

  1. Sleep Related Behavior Questionnaire

    Time frame: Month 1

    sleep safety aids. Total score (32-128). Higher scores indicate worse symptoms.

  2. Penn State Worry Questionnaire

    Time frame: Month 1

    worry. Total score (16-80). Higher scores indicate worse symptoms.

  3. Dimensional Obsessive Compulsive Scale

    Time frame: Month 1

    OC symptoms. Total score (0-80). Higher scores indicate worse symptoms.

  4. Insomnia Severity Index

    Time frame: Month 1

    insomnia. Total score (0-28). Higher scores indicate worse symptoms.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 10, 2018
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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