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Completed

NCT Number: NCT03684057

Targeting Worry to Improve Sleep

The purpose of this study is to test an app-based mindfulness training program for worry to see if it can help individuals decrease worry and improve sleep.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Nervous System Diseases Parasomnias Sleep Disturbance Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brown University

Providence, Rhode Island, 02903, United States

About this study

In this study, 80 individuals with worry interfering with sleep will be randomized to receive Unwinding Anxiety or to Treatment as Usual (50/50 chance). The active intervention period will last 2 months, with an optional 2-month follow-up period in which the intervention remains available. Changes in mindfulness, emotional reactivity, cognition and sleep behavior at specified time points will be measured. The primary engagement targets will be non-reactivity and worry. The primary behavioral outcome target will be sleep.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Score > 40 on the Penn State Worry Questionnaire (PSWQ)
  • Score ≥ to 40% on Worry Interfering with Sleep Scale (WISS)
  • Owns a smartphone
  • Willing to wear a sleep tracker for at least 1 week

Exclusion criteria

  • Any usage of psychotropic medication: not on a stable dosage 6+ weeks
  • Medical disorder of the severity that would interfere with ability to attend visits and complete study milestones
  • Use of benzodiazepine or hypnotic sleep aid on as needed (i.e. prn)
  • Known sleep disorder
  • Psychotic disorder
  • Post-traumatic Stress Disorder
  • Severe depression (Score > 3 on PHQ-2)
  • Current shift work employment
  • BMI > 35
  • Evening caffeine use
  • Pregnant women

Treatment and study plan

App-Delivered Mindfulness Training (MT)

Behavioral

Unwinding Anxiety is an app-delivered mindfulness training program which includes a progression through 30+ daily modules. Each module's training is delivered via short video tutorials and animations (~10 min/day). Each training builds on the previous one; modules are 'locked' so that they can only be viewed at a pace of 1/day (previous modules can be reviewed at any time). A built-in self-assessment is taken after every seven modules to ensure key concepts are learned before moving on with automated suggestions on which modules to repeat based on the self-assessment results. User-initiated guided practices range from short exercises (30 seconds) to manage anxiety the moment it arises to formal guided meditations (up to 15 minutes), and can be accessed at any time

Primary outcomes

  1. Change in Worry-related Sleep Disturbances

    Time frame: Baseline, 2 months

    5 questions from the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS-29) pertaining to anxiety and sleep will be used to assess worry-related sleep disturbances over the past 7 days. These questions are on a 5-point Likert scale where 1 is "Not at all" and 5 is "Very much". Scores can range from 5 to 25 and higher scores indicate a worse outcome.

Secondary outcomes

  1. Change in Worry

    Time frame: Baseline, 2 months

    Penn State Worry Questionnaire (PSWQ) will be used to assess worry. The PSWQ is a 16-item questionnaire that uses a 5-point Likert scale where 1 is "Not at all typical of me" and 5 is "Very typical of me". Scores can range from 16 to 80 and higher scores indicate a worse outcome

  2. Change in Total Sleep Time (TST)

    Time frame: Baseline, 2 months

    A Fitbit will be used to assess sleep trends over a 1 week period

  3. Changes in Non-reactivity

    Time frame: Baseline, 2 months

    Non-reactivity subscale from the 15-item Five Facet Mindfulness Questionnaire (FFMQ) will be used to measure changes in emotional reactivity. This subscale is based on responses to 3 questions measured on a 5-point Likert scale where 1 is "Never or rarely" and 5 is "Very often or always true". Scores can range from 3 to 15 and higher scores indicate a better outcome.

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Targeting Worry to Improve Sleep Using App-Based Mindfulness Training

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 25, 2018
Registry last updated
Oct 10, 2022

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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