Cognitive Behavioral Therapy for Treatment of Insomnia in Patients With Major Depression

January 11, 2023 updated by: University of Aarhus

Treatment of Insomnia in Patients With Major Depression Disorder Using Cognitive Behavioral Therapy, Sleep Restriction and Stimulus Control Therapy. A Randomized, Controlled 8 Week Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants are included from an Outpatient clinic and GPs in Aarhus. Initial assessment is carried out through a personal interview with the participants who are screened with Hamilton Depression Rating Scale, MINI (Mini International Neuropsychiatric Interview) and instructed to fill out an ISI-form (Insomnia Severity Index (Morin, 1993)), DBAS-16, Dysfunctional Beliefs and Attitudes about Sleep Scale, (Morin, 1993) and to keep a sleep diary for two weeks.

All participants go through an objective examination of their sleep through a polysomnography measuring brain activity (EEG), eye activity (EOG), muscular activity (EMG), heart rate, respiration a.o. during sleep. This happens on an outpatient basis with assistance of an experienced sleep technician. Data is analysed by an experienced sleep physician.

After assessment participants are randomized receiving either treatment as usual or CBT-I.

CBT-I includes: Sleep Restriction Therapy, Stimulus Control Therapy, Relaxation Training, Identification and analyzation of negative thoughts and cognitive distortion, Modification of negative thoughts about sleep, Reattribution, Implementation of "Scheduled worry", Relapse prevention.

Post-treatment participants undergo polysomnographic evaluation and screening with HDRS, ISI and DBAS. Again they keep a sleep diary.

Categorical variables are analysed with a chi-square test. Ordinal variables are analysed with non-parametrical tests (Wilcoxon-Mann-Whitney U-test) and variance analysis (ANOVA). Possible confounders as differences in demographics or other treatment, which may affect the target outcome, will be analysed in part with non-parametrical tests and in part in a logistic regression analysis. As secondary effect targets total sleep time and changes in polysomnography as well as changes in HDRS, dysfunctional assumptions on sleep and life quality are measured. STATA is used for data processing with SPSS as a possible alternative solution.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Midtjylland
      • Aarhus, Region Midtjylland, Denmark, 8200
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBT-I
Behavioral intervention: CBT-I
Behavioral: CBT-I
CBT-I
Behavioral: Treatment as usual
Treatment as usual
Active Comparator: Treatment as usual
Intervention: Control group receiving treatment as usual
Behavioral: Treatment as usual
Treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients Total sleep time (minutes).
Time Frame: 8 weeks
Obtained through sleep diary
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score on HamD17 (points)
Time Frame: 8 weeks
Obtained through semistructured interview
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

TrygFonden, Denmark

Investigators

  • Study Chair: Erik Roj Larsen, PhD, Psychiatry in the Region of Southern Denmark, Odense, Department of Psychiatry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

October 23, 2015

First Submitted That Met QC Criteria

February 5, 2016

First Posted (Estimate)

February 10, 2016

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109566

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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