Cognitive Behavioral Therapy for Treatment of Insomnia in Patients With Major Depression
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Depression
Study type: Interventional

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.
    

Intervention name(s): CBT-I; Treatment as usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): CBT-I; Treatment as usual
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sleep; Depression; Comorbid Insomnia; Cognitive Behavioral Therapy; Sleep Restriction; Stimulus Control therapy; Relaxation