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Can a phone app help veterans beat both insomnia and depression?

NCT ID NCT05456607

Symptom relief Sponsor: University of Rochester Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 4 times

Summary

This study tests whether a mobile app delivering cognitive behavioral therapy can help U.S. military veterans who have both insomnia and depression. 1,200 participants will receive either therapy for insomnia, depression, or both in sequence. The goal is to see which approach works best and for whom.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cognitive behavioral therapy delivered via a mobile app
What this could lead to
If successful, this could provide an effective, accessible digital treatment for veterans struggling with both insomnia and depression.
What could go wrong
This is a large trial, but it only includes U.S. military veterans, so results may not apply to everyone. The treatment is behavioral, not a drug, so benefits may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,200 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * English-speaking * U.S. Military Veterans * endorse depression (Patient Health Questionnaire-depression score \> 10) * endorse insomnia (Insomnia Severity Index score \> 10). Exclusion Criteria are limited in accordance with real world effectiveness trials, but will include: * pregnancy * history of bipolar disorder * history of psychosis * current use of anti-psychotic medications or mood stabilizers (e.g., lithium) * current suicidal ideation with active intent

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder insomnia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depression Insomnia

Contacts and locations

Locations

  • University of Rochester Sleep Research Laboratory

    Rochester, New York, 14642, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.