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

NCT ID: NCT02678702

Last Updated: 2023-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2020-04-30

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.

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBT-I

Behavioral intervention: CBT-I

Group Type: EXPERIMENTAL

CBT-I

Intervention Type: BEHAVIORAL

CBT-I

Treatment as usual

Intervention Type: BEHAVIORAL

Treatment as usual

Treatment as usual

Intervention: Control group receiving treatment as usual

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: BEHAVIORAL

Treatment as usual

Interventions

CBT-I

CBT-I

Intervention Type: BEHAVIORAL

Treatment as usual

Treatment as usual

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 67 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TrygFonden, Denmark

INDUSTRY

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erik Roj Larsen, PhD

Role: STUDY_CHAIR

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

Locations

Aarhus University Hospital

Aarhus, Central Jutland, Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 36233712 (View on PubMed)

Other Identifiers

109566

Identifier Type: -

Identifier Source: org_study_id