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Sleep and Mental Health App for Insomnia

N/A
Recruiting
Led By Lauren Asarnow, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current psychotherapy for depression, anxiety or sleep health deficits
Unstable major medical conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, and at months 1, 2, 3 and 8
Awards & highlights

Study Summary

This trial will test a phone app that helps improve sleep and mental health in adolescents.

Who is the study for?
This trial is for adolescents with sleep issues like insomnia or delayed sleep phase syndrome. Participants should not be using medications or herbs affecting sleep, have no recent hospitalization for substance use or suicide attempts, and should not have known sleep apnea or unstable medical conditions.Check my eligibility
What is being tested?
The study is examining a mobile health adaptation of a behavioral intervention aimed at improving sleep and mental health in adolescents. It involves comparing the effects of this new method (mTranS-C) against a control group to see which is more effective.See study design
What are the potential side effects?
Since the trial involves behavioral interventions rather than medication, side effects are minimal but may include discomfort from changing sleeping habits or stress from participation in regular sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently receiving therapy for depression, anxiety, or sleep issues.
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I do not have any unstable major medical conditions.
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I have been diagnosed with sleep apnea.
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I am taking medication or herbs that affect my sleep.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, and at months 1, 2, 3 and 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, and at months 1, 2, 3 and 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Pittsburgh Sleep Quality Index (PSQI)
Secondary outcome measures
Change in cortisol reactivity and recovery in response to a stress exposure
Change in the PHQ-9 (The 9 Item Patient Health Questionnaire For Depression)
Change in the SCARED (Screen for Child Anxiety Related Disorders) total score

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: mTranS-CExperimental Treatment1 Intervention
Access to a mobile and computer accessible adaptation of Transdiagnostic Sleep and Circadian Intervention
Group II: ControlActive Control1 Intervention
Access to a mobile and computer accessible control intervention that targets coping skills and sleep education.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mTranS-C
2019
N/A
~60

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,506 Previous Clinical Trials
15,238,495 Total Patients Enrolled
8 Trials studying Insomnia
1,033 Patients Enrolled for Insomnia
Lauren Asarnow, PhDPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
72 Total Patients Enrolled
2 Trials studying Insomnia
72 Patients Enrolled for Insomnia

Frequently Asked Questions

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

Is this experiment currently seeking participants?

"Confirmed, this medical trial is on the hunt for recruits. The initial post was published September 1st 2020, with an update made August 10th 2022. 60 patients need to join from a single site."

Answered by AI

How many participants are presently enrolled in this clinical investigation?

"Affirmative. The documentation on clinicaltrials.gov confirms that this experiment, which was initially launched September 1st 2020, is actively recruiting participants. Approximately 60 people are necessary to be recruited from one centre of care."

Answered by AI

Is the participant base of this experiment restricted to those who are over 45 years old?

"This clinical trial is seeking to enrol children between the ages of 12 and 18. Altogether, there are 25 trials for minors and 180 trials targeting senior citizens."

Answered by AI

Who is eligible to participate in this research project?

"This medical trial is accepting 60 participants between the ages of 12 and 18 with insomnia."

Answered by AI

Who else is applying?

What site did they apply to?
University of California, San Francisco
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
The Reducing Risk Study
2020. "The Reducing Risk Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03665337.
All > Delayed Sleep Phase Syndrome
~4 spots leftby Aug 2024
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