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

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Behavioral: CBT-I; Behavioral: Treatment as usual

• Registration Number: NCT02678702
• Lead Sponsor: University of Aarhus

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.

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 Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-10-23
• Study First Submitted QC: 2016-02-05
• Study First Posted: 2016-02-10
• Status Verified: 2016-11
• Primary Completion: 2020-04
• Study Completion: 2020-04
• Last Update Submitted: 2023-01-11
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT-I	Treatment as usual	Behavioral intervention: CBT-I
Treatment as usual	Treatment as usual	Intervention: Control group receiving treatment as usual
CBT-I	CBT-I	Behavioral intervention: CBT-I

Primary Outcome Measures

Name	Time	Method
Patients Total sleep time (minutes).	8 weeks	Obtained through sleep diary

Secondary Outcome Measures

Name	Time	Method
Score on HamD17 (points)	8 weeks	Obtained through semistructured interview

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Region Midtjylland, Denmark