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Drug-Free sleep program shows promise for mental health patients

NCT ID NCT05406414

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

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a non-medication sleep program for 88 adults with depression, bipolar disorder, or ADHD who also had insomnia. Participants received either the sleep program or standard sleep hygiene advice. The goal was to see if the program could improve sleep quality and reduce insomnia severity without using sleeping pills.

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

88 people

The number who actually took part.

Started

May 2022

Finished

Jul 2024

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: * Age ≥18 years * F31 Bipolar disorder, F32 unipolar depression or F90 attention deficit disorder * Insomnia Severity Index (ISI) ≥ 14 (exceeding the threshold for a sleep problem) * Sleep problems for 3 months: 3 times a week at least one of the following: * Sleep onset latency ≥ 30 minutes * Wake after sleep onset ≥ 30 minutes * Total sleep time ≥ 11 hours per day * Displaced circadian rhythm; sleeps earlier than 8 P.M. or later than 02 A.M. * Irregular circadian rhythm; bedtime varies ≥ 3 hours throughout the week Exclusion Criteria: * Acutely increased suicide risk (Central Regions guideline for assessment of suicide risk) * Active substance abuse (F10-19) * The sleep problem can be significantly explained by insufficient treatment of physical * disease affecting sleep (documented in patients electronic journal) * Unstable social situation (does not have a permanent residence) * Shift work (≥ 2 times a week for the last 2 months) * Pregnancy and breast-feeding

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Conditions

The condition(s) this trial relates to.

attention deficit hyperactivity disorder, inattentive type bipolar disorder Depression depressive disorder endogenous depression major affective disorder 6

As listed by the trial registrant

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

Attention deficit disorder Bipolar affective disorder Depression

Contacts and locations

Locations

  • Mette Kragh

    Aarhus C, 8000, Denmark

More trials for these conditions

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