DepressionNCT05406414
The Efficacy of a Transdiagnostic Sleep and Circadian Intervention for Patients With Mental Disorders and Sleep Problems
A study testing Transdiagnostic sleep and circadian treatment in people with Depression and Bipolar Affective Disorder, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of this study is to examine the effect of a non-pharmacological transdiagnostic sleep intervention as add on to standard treatment for bipolar disorder, depression and attention deficit disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Bipolar Affective Disorder, Attention Deficit Disorder
- What is being tested?
- Transdiagnostic sleep and circadian treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteDenmark
- Study dates
- 23 May 2022to 31 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Better Sleep Without Medicine - a Cross-sectoral, Quantitative and Qualitative Study for Adult Patients With Mental Disorders and Sleep Problems
The aim of this study is to examine the effect of a non-pharmacological transdiagnostic sleep intervention as add on to standard treatment for bipolar disorder, depression and attention deficit disorder. Our hypothesis is that the intervention will reduce the severity of the sleep problem and increase sleep quality compared to a control group receiving sleep hygiene education.
Read the detailed description
Sleep problems include insomnia, circadian rhythm disorders, hypersomnia, and inadequate sleep hygiene. Patients suffering from mental illness are more likely to suffer from sleep problems than the general population. Sleep problems can aggravate the underlying disorder, cause relapse and suicidal ideation. Sleep problems often persist after the mental disorder is successfully treated. Sleep medication is often used but not recommended for long term use. Non-pharmacological treatment of sleep problems is in demand by patients, but treatment options are few. The present intervention is based on a transdiagnostic manual combining Cognitive Behavioral Therapy for Insomnia with chronotherapy, but more research on the efficacy is warranted.
The aim of this study is to investigate whether the intervention reduces the severity of the sleep problem, increases sleep quality, leads to increased sleep efficiency, reduces sleep latency and awakenings, provides better quality of life, increases personal recovery, provides greater readiness to take on a job or reduces consumption of sleep medication.
- Being tested
- Transdiagnostic sleep and circadian treatment, Active waitlist control group
- Medical subject headings
- Depression, Bipolar Disorder, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdiagnostic sleep and circadian treatmentBehavioural
The intervention group receives sleep treatment consisting of 6 sessions of 60 minutes each over 6 weeks. The sessions are delivered individually and have the following content:
- Assessment and introduction to the sleep diary
- Review of sleep diary - agreements on behavior changes and goals.
- Information on normal sleep, sleep problems and circadian rhythm
- Cognitive techniques
- Introduction to relaxation training
- Follow-up on goals and plan for prevention relapse of sleep problems
Active waitlist control groupBehavioural
The control group receives sleep hygiene education consisting of a single session in which 10 points of sleep advice are presented. They receive a booklet on how to promote good sleep practice and must work on their own for the next 6 weeks to implement this while waiting for the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Transdiagnostic sleep and circadian treatment | Experimental | The intervention group receives sleep treatment consisting of 6 sessions of 60 minutes each over 6 weeks. Receives: Behavioral: Transdiagnostic sleep and circadian treatment |
| Active waitlist control group | Active comparator | The control group receives sleep hygiene education Receives: Behavioral: Active waitlist control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the severity of the sleep problem
Is measured by Insomnia Severity Index. A self-report instrument measuring the patient's perception of insomnia. The scale ranges from 0 to 28. The higher the score the more severe the insomnia.
Measured: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint)
Change in sleep quality.
Measured by Pittsburgh Sleeping Quality Index (PSQI). The score is between 0 and 21, "0" indicating no difficulty and "21" indicating severe difficulties.
Measured: Is measured at inclusion (baseline/ week 0) and at week 6 (endpoint).
Secondary outcomes (8)
Change in well-being
Measured on The WHO-5 Well-Being Index (WHO-5). A questionnaire which measures well-being on a scale ranging from 0 to 100, the higher the score the more well-being.
Measured: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint
Level of personal recovery
Measured by the questionnaire INSPIRE-O. A questionnaire which measures personal recovery on a scale ranging from 5 to 25, the higher the score the more recovery.
Measured: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint).
Change in readiness to take on a job
Measured by the questionnaire, The Work Ability Index. A score of 0 shows the lowest possibility that the person would take on a job, the score 10 is the highest possibility
Measured: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint)
Changes in health-related items.
The International EQ-5D-5L questionnaire is applied to estimate quality-adjusted years of life.
Measured: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint)
Change in consumption of sleep medications
Daily use of sedatives and hypnotics will be measured by medication registration use in sleep diaries during the study period.
Measured: Is registered daily during the 6 week study period
Changes in sleep efficiency
Is calculated based on the participant's registrations in sleep diaries and by measurements from actigraphs.
Measured: Is measured daily during the 6 week study period.
Changes in sleep latency
Is calculated based on the participant's registrations in sleep diaries and by measurements from actigraphs.
Measured: Is measured daily during the 6 week study period
Changes in sleep nocturnal awakenings
Is calculated based on the participant's registrations in sleep diaries and by measurements from actigraphs.
Measured: Is measured daily during the 6 week study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start23 May 2022
- Primary completion30 May 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mette Kragh, Principal investigator, Department of affective disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406414
- Sponsor's protocol ID
- ADA_1
- Status last verified
- Dec 2024
- First submitted
- 1 Jun 2022
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kragh M, Dyrberg H, Speed M, Pedersen P, Kristiansen ST, Martiny K. The efficacy of a transdiagnostic sleep intervention for outpatients with sleep problems and depression, bipolar disorder, or attention deficit disorder: study protocol for a randomized controlled trial. Trials. 2024 Jan 16;25(1):57. doi: 10.1186/s13063-024-07903-6.
PubMed 38229181
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Sleep Without Medicine - a Cross-sectoral, Quantitative and Qualitative Study for Adult Patients With Mental Disorders and Sleep Problems
- ClinicalTrials.gov ID
- NCT05406414
- Acronym / sponsor ID
- ADA_1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 23 May 2022 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 6 Jun 2022 (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 aim of this study is to examine the effect of a non-pharmacological transdiagnostic sleep intervention as add on to standard treatment for bipolar disorder, depression and attention deficit disorder. Our hypothesis is that the intervention will reduce the severity of the sleep problem and increase sleep quality compared to a control group receiving sleep hygiene education.
Detailed description
Sleep problems include insomnia, circadian rhythm disorders, hypersomnia, and inadequate sleep hygiene. Patients suffering from mental illness are more likely to suffer from sleep problems than the general population. Sleep problems can aggravate the underlying disorder, cause relapse and suicidal ideation. Sleep problems often persist after the mental disorder is successfully treated. Sleep medication is often used but not recommended for long term use. Non-pharmacological treatment of sleep problems is in demand by patients, but treatment options are few. The present intervention is based on a transdiagnostic manual combining Cognitive Behavioral Therapy for Insomnia with chronotherapy, but more research on the efficacy is warranted.
The aim of this study is to investigate whether the intervention reduces the severity of the sleep problem, increases sleep quality, leads to increased sleep efficiency, reduces sleep latency and awakenings, provides better quality of life, increases personal recovery, provides greater readiness to take on a job or reduces consumption of sleep medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transdiagnostic sleep and circadian treatment | Experimental | Behavioral: Transdiagnostic sleep and circadian treatmentThe intervention group receives sleep treatment consisting of 6 sessions of 60 minutes each over 6 weeks. |
| Active waitlist control group | Active comparator | Behavioral: Active waitlist control groupThe control group receives sleep hygiene education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (7 listed)
- 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)
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 |
|---|---|---|
| Transdiagnostic sleep and circadian treatmentThe intervention group receives sleep treatment consisting of 6 sessions of 60 minutes each over 6 weeks. The sessions are delivered individually and have the following content: 1. Assessment and introduction to the sleep diary 2. Review of sleep diary - agreements on behavior changes and goals. 3. Information on normal sleep, sleep problems and circadian rhythm 4. Cognitive techniques 5. Introduction to relaxation training 6. Follow-up on goals and plan for prevention relapse of sleep problems | Behavioural | Transdiagnostic sleep and circadian treatment |
| Active waitlist control groupThe control group receives sleep hygiene education consisting of a single session in which 10 points of sleep advice are presented. They receive a booklet on how to promote good sleep practice and must work on their own for the next 6 weeks to implement this while waiting for the intervention. | Behavioural | Active waitlist control group |
Primary outcome
Change in the severity of the sleep problem
Time frame: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint)
Is measured by Insomnia Severity Index. A self-report instrument measuring the patient's perception of insomnia. The scale ranges from 0 to 28. The higher the score the more severe the insomnia.
Change in sleep quality.
Time frame: Is measured at inclusion (baseline/ week 0) and at week 6 (endpoint).
Measured by Pittsburgh Sleeping Quality Index (PSQI). The score is between 0 and 21, "0" indicating no difficulty and "21" indicating severe difficulties.
8 secondary outcomes
Change in well-being
Time frame: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint
Level of personal recovery
Time frame: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint).
Change in readiness to take on a job
Time frame: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint)
Changes in health-related items.
Time frame: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint)
Change in consumption of sleep medications
Time frame: Is registered daily during the 6 week study period
Changes in sleep efficiency
Time frame: Is measured daily during the 6 week study period.
Changes in sleep latency
Time frame: Is measured daily during the 6 week study period
Changes in sleep nocturnal awakenings
Time frame: Is measured daily during the 6 week study period.
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 30 Sep 2025.
- Derived from this study: PubMed 38229181Kragh M, Dyrberg H, Speed M, Pedersen P, Kristiansen ST, Martiny K. The efficacy of a transdiagnostic sleep intervention for outpatients with sleep problems and depression, bipolar disorder, or attention deficit disorder: study protocol for a randomized controlled trial. Trials. 2024 Jan 16;25(1):57. doi: 10.1186/s13063-024-07903-6.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Mette Kragh principal investigator
Department of affective disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdiagnostic sleep and circadian treatment in people with Depression and Bipolar Affective Disorder, run by University of Aarhus at 1 site in Denmark.
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 9 inclusion and 7 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 30 Sep 2025. 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 Denmark. 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 the severity of the sleep problem (time frame: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05406414, which also lists 1 linked publication.
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 30 Sep 2025.