Cognitive Behavioral Therapy for Sleep and Circadian Disturbances (CBT-I) in Treatment-Resistant Schizophrenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorJimmi Nielsen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with ICD-10 schizophrenia (DF20), chronic paranoid psychosis (DF22), schizo-affective disorder (DF25) or other non-organic psychosis (DF28-DF29)
Treatment resistance according to TRRIP criteria
Sleeping difficulties (minimum duration 3 months)
ISI score >14
Disqualifiers
Psychiatric admission last six months (more than 1 week or resulted in significant changes in psychopharmacological treatment)
Substance abuse to a degree that will interfere with participation.
Diagnoses of sleep apnea/CPAP use
Trial design
Design model
Parallel
Treatments tested in this trial
CBT-I
Other interventionCognitive therapy tailored for insomnia symptoms.
CBT
Other interventionCognitive behavioral therapy for general psychopathology
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Cognitive Behavioral Therapy for insomniaExperimental treatment 1 intervention
Group B: Cognitive Behavioral TherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Insomnia 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.Secondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jimmi Nielsen
Lead sponsor
Copenhagen University Hospital, Hvidovre
Sponsor institution
Source ClinicalTrials.gov