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

University of Aarhus88 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Depression Bipolar Affective Disorder Attention Deficit Disorder

Interventions

Transdiagnostic sleep and circadian treatmentBEHAVIORAL

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 groupBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mette Kragh

Aarhus C, Denmark

Outcomes

Primary Outcomes

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.

Time frame: 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.

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

Secondary Outcomes

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.

Time frame: 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.

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

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

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.