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

NCT02678702 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2023-01-12

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

CBT-I

CBT-I

BEHAVIORAL

Treatment as usual

Treatment as usual

Sponsors & Collaborators

  • TrygFonden, Denmark

    collaborator INDUSTRY

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Erik Roj Larsen, PhD · Psychiatry in the Region of Southern Denmark, Odense, Department of Psychiatry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
67 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • Denmark

Study Locations

More Related Trials

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 NCT02678702 on ClinicalTrials.gov