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

NCT ID: NCT05406414

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-23
• Study Completion Date: 2024-07-31

Brief 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. 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.

Conditions

Depression; Bipolar Affective Disorder; Attention Deficit Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transdiagnostic sleep and circadian treatment

The intervention group receives sleep treatment consisting of 6 sessions of 60 minutes each over 6 weeks.

Group Type: EXPERIMENTAL

Transdiagnostic sleep and circadian treatment

Intervention Type: 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:

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

Active waitlist control group

The control group receives sleep hygiene education

Group Type: ACTIVE_COMPARATOR

Active waitlist control group

Intervention Type: 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.

Interventions

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:

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mette Kragh

Role: PRINCIPAL_INVESTIGATOR

Department of affective disorders

Locations

Mette Kragh

Aarhus C, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 38229181 (View on PubMed)

Other Identifiers

ADA_1

Identifier Type: -

Identifier Source: org_study_id