InsomniaNCT03665337
The Reducing Risk Study
A study testing mTranS-C in people with Insomnia and Delayed Sleep Phase, run by University of California, San Francisco at 1 site in United States.
Trial summary
The present study will test an innovative mobile health adaptation of a behavioral intervention that improves sleep and mental health concerns among adolescents. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Insomnia, Delayed Sleep Phase
- What is being tested?
- mTranS-C
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 24 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- any current psychiatric illness
- currently use of medications or herbs with known effects on sleep
- hospitalization for substance use or suicide within the past 12 months
- known sleep apnea
- unstable major medical conditions
- current psychotherapy for depression, anxiety or sleep health deficits
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Reducing Risk: A Comprehensive mHealth Sleep Health Intervention for Adolescents at Risk for Depression and Anxiety Disorders
The present study will test an innovative mobile health adaptation of a behavioral intervention that improves sleep and mental health concerns among adolescents.
- Conditions
- Insomnia, Delayed Sleep Phase
- Being tested
- mTranS-C, Control
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mTranS-CBehavioural
MOBILE HEALTH
ControlBehavioural
MOBILE HEALTH
| Study group | Role | What they receive |
|---|---|---|
| mTranS-C | Experimental | Access to a mobile and computer accessible adaptation of Transdiagnostic Sleep and Circadian Intervention Receives: Behavioral: mTranS-C |
| Control | Active comparator | Access to a mobile and computer accessible control intervention that targets coping skills and sleep education. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pittsburgh Sleep Quality Index (PSQI)
Validated questionnaire; total score range between 0 and 21, with higher numbers representing worse sleep quality
Measured: baseline to end of treatment (anticipated average exposure 2 months), months 3 and 8
Secondary outcomes (3)
Change in the PHQ-9 (The 9 Item Patient Health Questionnaire For Depression)
A validated questionnaire measuring depressive symptom severity. The total score ranges between 0 and 19. Scores are rated as minimal (0-4), mild (5-9), moderate (10-14), and severe (15-19).
Measured: baseline to end of treatment (anticipated average exposure 2 months), months 3 and 8
Change in the SCARED (Screen for Child Anxiety Related Disorders) total score
A validated 41-item questionnaire assessing self-report of anxiety in children and adolescents. Individual items are rated 'Not True or Hardly Ever True' (Score 0), 'Somewhat True or Sometimes True' (Score 1), or 'Very True or Often True' (Score 2). Individual response scores are then summed and for a total score. Total scores range from 0 to 82.
Measured: baseline, and at months 1, 2, 3 and 8
Change in cortisol reactivity and recovery in response to a stress exposure
A validated biological measure of stress reactivity and recovery in response to a stress exposure. Changes in cortisol production at 15, 30 and 45 minutes following a stressor will be evaluated.
Measured: baseline and at month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start1 Sep 2020
- Primary completion24 Oct 2024
- Study completion24 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauren Asarnow, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665337
- Sponsor's protocol ID
- IRB-47676
- Status last verified
- Jul 2026
- First submitted
- 5 Sep 2018
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Risk: A Comprehensive mHealth Sleep Health Intervention for Adolescents at Risk for Depression and Anxiety Disorders
- ClinicalTrials.gov ID
- NCT03665337
- Acronym / sponsor ID
- IRB-47676
- Conditions
- Insomnia, Delayed Sleep Phase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study will test an innovative mobile health adaptation of a behavioral intervention that improves sleep and mental health concerns among adolescents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mTranS-C | Experimental | Behavioral: mTranS-CAccess to a mobile and computer accessible adaptation of Transdiagnostic Sleep and Circadian Intervention |
| Control | Active comparator | Behavioral: ControlAccess to a mobile and computer accessible control intervention that targets coping skills and sleep education. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- any current psychiatric illness
- currently use of medications or herbs with known effects on sleep
- hospitalization for substance use or suicide within the past 12 months
- known sleep apnea
- unstable major medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mTranS-CMOBILE HEALTH | Behavioural | mTranS-C |
| ControlMOBILE HEALTH | Behavioural | Control |
Primary outcome
Change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: baseline to end of treatment (anticipated average exposure 2 months), months 3 and 8
Validated questionnaire; total score range between 0 and 21, with higher numbers representing worse sleep quality
3 secondary outcomes
Change in the PHQ-9 (The 9 Item Patient Health Questionnaire For Depression)
Time frame: baseline to end of treatment (anticipated average exposure 2 months), months 3 and 8
Change in the SCARED (Screen for Child Anxiety Related Disorders) total score
Time frame: baseline, and at months 1, 2, 3 and 8
Change in cortisol reactivity and recovery in response to a stress exposure
Time frame: baseline and at month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Insomnia
Active, not recruitingObservational study
Association Between Polycystic Ovary Syndrome and Sleep Quality: A Questionnaire-Based Study
Sleep Disorder, Polycystic Ovarian Syndrome (PCOS)
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
Recruiting
Music Therapy in Post-Stroke Patients: A Clinical Trial
CVA (Cerebrovascular Accident), Ictus
Recruiting
Physical Activity, Sleep Quality, and Respiratory Function in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Sleep Quality
RecruitingObservational study
Night Pain Module for Rotator Cuff-Related Shoulder Pain
Shoulder Pain, Rotator Cuff Related Shoulder Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Asarnow, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mTranS-C in people with Insomnia and Delayed Sleep Phase, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pittsburgh Sleep Quality Index (PSQI) (time frame: baseline to end of treatment (anticipated average exposure 2 months), months 3 and 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.