An interventional study of CBT-I and Treatment as usual in Insomnia, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years to 67 Years. Per ClinicalTrials.gov, last updated 2023-01-12.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
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.
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.
1,855 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 593 are open to participants now.
This study's enrollment of 47 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
Behavioral intervention: CBT-I
Behavioral: CBT-I · Behavioral: Treatment as usual
Intervention: Control group receiving treatment as usual
Behavioral: Treatment as usual
CBT-I
Treatment as usual
Patients Total sleep time (minutes).
Obtained through sleep diary
Time frame: 8 weeks
Score on HamD17 (points)
Obtained through semistructured interview
Time frame: 8 weeks
Plan to share: Undecided
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
University of Aarhus