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Completed

NCT Number: NCT05406414

The Efficacy of a Transdiagnostic Sleep and Circadian Intervention for 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.

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Key information

Conditions

Depression Attention Deficit Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Behavior Behavioral Symptoms Bipolar Affective Disorder Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders Neurodevelopmental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mette Kragh

Aarhus C, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transdiagnostic sleep and circadian treatment

Behavioral

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 group

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change in well-being

    Time frame: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint

    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.

  2. Level of personal recovery

    Time frame: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint).

    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.

  3. 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)

    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

  4. Changes in health-related items.

    Time frame: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint)

    The International EQ-5D-5L questionnaire is applied to estimate quality-adjusted years of life.

  5. Change in consumption of sleep medications

    Time frame: Is registered daily during the 6 week study period

    Daily use of sedatives and hypnotics will be measured by medication registration use in sleep diaries during the study period.

  6. Changes in sleep efficiency

    Time frame: Is measured daily during the 6 week study period.

    Is calculated based on the participant's registrations in sleep diaries and by measurements from actigraphs.

  7. Changes in sleep latency

    Time frame: Is measured daily during the 6 week study period

    Is calculated based on the participant's registrations in sleep diaries and by measurements from actigraphs.

  8. Changes in sleep nocturnal awakenings

    Time frame: Is measured daily during the 6 week study period.

    Is calculated based on the participant's registrations in sleep diaries and by measurements from actigraphs.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Better Sleep Without Medicine - a Cross-sectoral, Quantitative and Qualitative Study for Adult Patients With Mental Disorders and Sleep Problems

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 6, 2022
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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