Using a randomized controlled design, the project aims to test if cognitive behavioral therapy interventions specifically targeting sleep disorders can significantly lessen the burden of the disrupted sleep in patients with treatment resistant schizophrenia (TRS) and by proxy lead to a reduction in psychotic symptoms and improvement in quality of life. We are including treatment-resistant patients with schizophrenia other nonorganic and chronic psychoses and in addition meeting the criteria of a sleep or circadian disorder. Included patients will be block randomized to either 8-10 sessions of CBT-I (active treatment) with a specific focus on sleep or 8-10 sessions of regularCBT with a specific focus on patients' psychopathology (treatment as usual) approx.1 session/week. After 12 weeks the full battery of assessments will be repeated forboth groups. Primary analyses will be to identify group-difference in changes using repeated measure ANOVA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Mental Health Centre Glostrup
Glostrup, Denmark, Denmark
RECRUITINGInsomnia severity index
Patient-entered questionnaire measuring sleep difficulties. Seven items. Range of score 0-28. Higher scores indicate more severe insomnia.
Time frame: Baseline, after 12-weeks and 24-weeks.
Positive and negative syndrome scale (PANSS)
32-items clinician administered rating scale measuring psychopathology. Range of score 30-210. Higher scores indicate higher level of symptoms
Time frame: Baseline, after 12-weeks and 24-weeks.
WHO well being index
5-five items patient-entered questionnaire. Measuring quality of life. Range of score 0-100. Higher scores indicate better quality of life.
Time frame: Baseline, after 12-weeks and 24-weeks.
Global Assessment of Functioning (GAF)
Rating scale measuring level of functioning. Clinician administered. Range of score 0-100. Higher scores indicate higher level of functioning.
Time frame: Baseline, after 12-weeks and 24-weeks.
Functioning Assessment Short Test (FAST)
Clinician administered rating scale measuring level of functioning. Range of score 0-72. Higher scores indicate lower level of functioning.
Time frame: Baseline, after 12-weeks and 24-weeks.
Personal and Social Performance scale
Semi-structured interview. Measuring level of functioning. Range of score 0-100. Higher scores indicate higher level of functioning.
Time frame: Baseline, after 12-weeks and 24-weeks.
Process of recovery questionnaire (QPR)
Questionnaire. Range 0-60. Higher scores indicate better outcome.
Time frame: Baseline, after 12-weeks and 24-weeks.
Sleep onset latency (PSG)
Time until sleep verified by polysomnography. Measured in minutes. Increasing number is associated with poorer sleep.
Time frame: Baseline and after 12-weeks.
Sleep efficiency (PSG)
Time with verified sleep divided by Time spent in bed and multiplied by 100. Measured by polysomnography. Higher percentage is associated with better sleep quality.
Time frame: Baseline and after 12-weeks.
Wake after sleep onset, number of awakenings (PSG)
Number of wake periods after initial onset of sleep. Measured in number of awakenings . Higher number is associated with poorer sleep quality.
Time frame: Baseline and after 12-weeks.
Wake after sleep onset, duration of wake periods (PSG)
Duration of wake periods after initial onset of sleep. Measured in minutes of duration. Longer duration is associated with poorer sleep quality.
Time frame: Baseline and after 12-weeks.
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