CompletedNot Applicable

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

Denmark47 participantsStarted 2015-08

Plain-language 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.

Who can participate

Age range18 Years – 67 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Patients Total sleep time (minutes).

Timeframe: 8 weeks

Trial details

NCT IDNCT02678702

SponsorUniversity of Aarhus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04