The Efficacy of a Transdiagnostic Sleep and Circadian Intervention for Patients With Mental Disorders and Sleep Problems

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.

Study Overview

• Status: Completed
• Conditions: Depression; Attention Deficit Disorder; Bipolar Affective Disorder
• Intervention / Treatment: Behavioral: Transdiagnostic sleep and circadian treatment; Behavioral: Active waitlist control group

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 Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus C, Denmark, 8000
    • Mette Kragh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transdiagnostic sleep and circadian treatment; The intervention group receives sleep treatment consisting of 6 sessions of 60 minutes each over 6 weeks.	Behavioral: Transdiagnostic sleep and circadian treatment; 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 Comparator: Active waitlist control group; The control group receives sleep hygiene education	Behavioral: Active waitlist control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Is measured at inclusion (baseline/ week 0) and at week 6 (endpoint).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	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.	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.	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.	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.	Is measured daily during the 6 week study period.

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Mette Kragh, Department of affective disorders

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2022
• Primary Completion (Actual): May 30, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Mental Disorders; Behavioral Symptoms; Mood Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Behavior; Depression; Bipolar Disorder; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: ADA_1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No