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

University of Aarhus

Status: Completed

Conditions: Attention Deficit Disorder; Bipolar Affective Disorder; Depression

Treatments: Behavioral: Transdiagnostic sleep and circadian treatment; Behavioral: Active waitlist control group

Study type: Interventional

Funder types: Other

Identifiers

NCT05406414

ADA_1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Transdiagnostic sleep and circadian treatment

Experimental group

Description:

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

Treatment:

Behavioral: Transdiagnostic sleep and circadian treatment

Active waitlist control group

Active Comparator group

Description:

The control group receives sleep hygiene education

Treatment:

Behavioral: Active waitlist control group