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

NCT05406414 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-09-30

No results posted yet for this study

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

Interventions

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: 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

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.

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Mette Kragh · Department of affective disorders

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-23
Primary Completion
2024-05-30
Completion
2024-07-31

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05406414 on ClinicalTrials.gov