Transdiagnostic Sleep and Anxiety Treatment

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03664310

Enrollment

Registered

2018-09-10

Start date

2017-08-01

Completion date

2018-05-12

Last updated

2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders

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.

Interventions

OTHERFSET Anxiety and Sleep Treatment

Computerized anxiety and insomnia intervention.

OTHERControl

Physical health control

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026