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Behavioral Sleep Program for Sleep Disturbances

N/A

Waitlist Available

Led By Ulrich Kirk, PhD

Research Sponsored by University of Southern Denmark

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to immediately post-intervention and 2-week follow-up

Awards & highlights

Study Summary

This trial will test if an 18-day smartphone-based sleep program combining CBTi and mindfulness concepts can improve sleep quality among US adults with sleep disturbances.

Who is the study for?

This trial is for English-speaking adults who have trouble sleeping, own a smartphone, and score 11 or higher on the Insomnia Severity Index. It's not for those who've done CBTi recently or have severe insomnia with risks like depression or self-harm.Check my eligibility

What is being tested?

The study tests an app-based sleep program from Headspace Health that uses cognitive behavioral therapy and mindfulness to improve sleep quality. Participants will use the app for 18 days, tracking their sleep and learning techniques to reduce nighttime disturbances.See study design

What are the potential side effects?

Since this is a non-pharmacological intervention focusing on behavior and mindfulness, significant side effects are not expected. However, participants may experience frustration if they do not see immediate improvements in their sleep patterns.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to immediately post-intervention and 2-week follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to immediately post-intervention and 2-week follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to immediately post-intervention and 2-week follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Actigraphy

Insomnia Severity Index (ISI)

Sleep Diary

Secondary outcome measures

General Anxiety Disorder-7 (GAD-7)

Mindful Attention Awareness Scale (MAAS)

Patient Health Questionnaire-8 (PHQ8)

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: WaitlistExperimental Treatment1 Intervention

Group II: Sleep ProgramActive Control1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Southern DenmarkLead Sponsor

529 Previous Clinical Trials

1,930,834 Total Patients Enrolled

Virginia Polytechnic Institute and State UniversityOTHER

141 Previous Clinical Trials

27,634 Total Patients Enrolled

Ulrich Kirk, PhDPrincipal InvestigatorUniversity of Southern Denmark

1 Previous Clinical Trials

225 Total Patients Enrolled

Media Library

Sleep Disorder Research Study Groups: Sleep Program, Waitlist

Sleep Disorder Clinical Trial 2023: Headspace Health Sleep Program Highlights & Side Effects. Trial Name: NCT05872672 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any enrollment slots available for this research project?

"According to the data hosted on clinicaltrials.gov, this medical research is not actively seeking participants at present. The trial was initiated July 1st 2023 and last updated May 23rd 2023. At present there are 140 other studies recruiting patients across the globe."

Answered by AI

What are the key goals of this experiment?

"The primary measure of success for this trial, which will span from baseline to immediately post-intervention and two weeks afterwards, is Sleep Diary. Secondary metrics include the Perceived Stress Scale (PSS-10), Patient Health Questionnaire-8 (PHQ8) and General Anxiety Disorder-7 (GAD-7). PSS assesses stress with a 0 - 40 score range where higher values indicate greater perceived stress while PHQ8 grades depression on a scale ranging from 0 - 24. GAD 7 evaluates anxiety through an ordinal rating system between 0 - 3."

Answered by AI

Recent research and studies

Journal of Affective DisordersJournal

The PHQ-8 as a Measure of Current Depression in the General Population

Kroenke, Kurt, Tara W. Strine, Robert L. Spitzer, Janet B.W. Williams, Joyce T. Berry, and Ali H. Mokdad. 2009. “The PHQ-8 as a Measure of Current Depression in the General Population”. Journal of Affective Disorders. Elsevier BV. doi:10.1016/j.jad.2008.06.026.

clinicaltrials.govStudy

Assessment of a Behavioral Sleep Program in a Population With Sleep Disturbances

Ulrich Kirk 2023. "Assessment of a Behavioral Sleep Program in a Population With Sleep Disturbances". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05872672.