NCT02678702

Brief Summary

Participants (N=47) are patients with major depression. Participants are assessed with clinical interview, polysomnographic evaluation and screening with Insomnia Severity Index (ISI), Dysfunctional Beliefs About Sleep-scale (DBAS), HDRS, MINI and Sleep Diary pre and post treatment. Participants are randomly assigned to either treatment as usual or CBT-I. The latter receives individual as well as group therapy with CBT-I during 6 sessions. Post-treatment: The investigators will compare changes in sleep diary parameters, HamD17, ISI and DBAS. Data are analyzed by using Chi-square test, Wilcoxon-Mann-Whitney U-test and ANOVA. STATA is used for data-processing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

January 12, 2023

Status Verified

November 1, 2016

Enrollment Period

4.7 years

First QC Date

October 23, 2015

Last Update Submit

January 11, 2023

Conditions

Insomnia

Keywords

SleepDepressionComorbid InsomniaCognitive Behavioral TherapySleep RestrictionStimulus Control therapyRelaxation

Outcome Measures

Primary Outcomes (1)

  • Patients Total sleep time (minutes).

    Obtained through sleep diary

    8 weeks

Secondary Outcomes (1)

  • Score on HamD17 (points)

    8 weeks

Study Arms (2)

CBT-I

EXPERIMENTAL

Behavioral intervention: CBT-I

Behavioral: CBT-IBehavioral: Treatment as usual

Treatment as usual

ACTIVE COMPARATOR

Intervention: Control group receiving treatment as usual

Behavioral: Treatment as usual

Interventions

CBT-IBEHAVIORAL

CBT-I

CBT-I
Treatment as usualBEHAVIORAL

Treatment as usual

CBT-ITreatment as usual

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unipolar depression, either as a single episode or as periodic depression.
  • HAM-D17 \> 18, i.e. moderate to severe depression.
  • Time spent on falling asleep: more than 30 minutes at least three nights a week or
  • Interrupted sleep with wake periods lasting more than 30 minutes at least three nights a week.
  • Symptoms must have lasted for at least a month.

You may not qualify if:

  • Other sleep disorder (e.g. moderat to severe Sleep apnoea and Periodic Limb Movements)
  • Physical disorder that affects sleep to a considerable degree.
  • Schizophrenia and bipolar disorder.
  • Subject to other ongoing psychological treatment besides standard treatment.
  • Suicidal to the equivalent of level 3 on HAM-D 17.
  • Active substance abuse problem.
  • Pregnancy.
  • Shift work.
  • Do not speak or understand danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, Central Jutland, 8200, Denmark

Location

Related Publications (1)

  • Dyrberg H, Bjorvatn B, Larsen ER. Cognitive Behavioral Therapy for Chronic Insomnia in Outpatients with Major Depression-A Randomised Controlled Trial. J Clin Med. 2022 Oct 1;11(19):5845. doi: 10.3390/jcm11195845.

    PMID: 36233712DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersDepression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Erik Roj Larsen, PhD

    Psychiatry in the Region of Southern Denmark, Odense, Department of Psychiatry

    STUDY CHAIR

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

October 23, 2015

First Posted

February 10, 2016

Study Start

August 1, 2015

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

January 12, 2023

Record last verified: 2016-11

Locations

DK(1)