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

NCT05406414 | Completed DMC

• 1 other identifier: ADA_1
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Bipolar Affective Disorder; Attention Deficit Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Change in well-being

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

• Level of personal recovery

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

• Change in readiness to take on a job

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

• Changes in health-related items.

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

• Change in consumption of sleep medications

  Is registered daily during the 6 week study period

Study Arms (2)

Transdiagnostic sleep and circadian treatment

EXPERIMENTAL

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

Behavioral: Transdiagnostic sleep and circadian treatment

Active waitlist control group

ACTIVE COMPARATOR

The control group receives sleep hygiene education

Behavioral: Active waitlist control group

Interventions

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: 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

Transdiagnostic sleep and circadian treatment

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.

Active waitlist control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Mette Kragh

Aarhus C, 8000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 38229181 DERIVED

MeSH Terms

Conditions

Depression; Bipolar Disorder; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Study Officials

• Mette Kragh

  Department of affective disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 6, 2022
• Study Start: May 23, 2022
• Primary Completion: May 30, 2024
• Study Completion: July 31, 2024
• Last Updated: September 30, 2025

Record last verified: 2024-12

Locations

DK (1)