Cognitive Behavioral Therapy for Sleep and Circadian Disturbances (CBT-I) in Treatment-Resistant Schizophrenia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Insomnia severity index
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Sleep laboratory employees
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Stable psychopharmacological treatment the last month
- •Only legal competent patient can participant
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Insomnia severity index
Time Frame: Baseline, after 12-weeks and 24-weeks.
Patient-entered questionnaire measuring sleep difficulties. Seven items. Range of score 0-28. Higher scores indicate more severe insomnia.
Secondary Outcomes
- Positive and negative syndrome scale (PANSS)(Baseline, after 12-weeks and 24-weeks.)
- WHO well being index(Baseline, after 12-weeks and 24-weeks.)
- Global Assessment of Functioning (GAF)(Baseline, after 12-weeks and 24-weeks.)
- Functioning Assessment Short Test (FAST)(Baseline, after 12-weeks and 24-weeks.)
- Personal and Social Performance scale(Baseline, after 12-weeks and 24-weeks.)
- Process of recovery questionnaire (QPR)(Baseline, after 12-weeks and 24-weeks.)
- Sleep onset latency (PSG)(Baseline and after 12-weeks.)
- Sleep efficiency (PSG)(Baseline and after 12-weeks.)
- Positive and negative syndrome scale (PANSS)(Baseline, after 12-weeks and 24-weeks.)
- WHO well being index(Baseline, after 12-weeks and 24-weeks.)
- Global Assessment of Functioning (GAF)(Baseline, after 12-weeks and 24-weeks.)
- Functioning Assessment Short Test (FAST)(Baseline, after 12-weeks and 24-weeks.)
- Personal and Social Performance scale(Baseline, after 12-weeks and 24-weeks.)
- Process of recovery questionnaire (QPR)(Baseline, after 12-weeks and 24-weeks.)
- Sleep onset latency (PSG)(Baseline and after 12-weeks.)
- Sleep efficiency (PSG)(Baseline and after 12-weeks.)
- Wake after sleep onset, number of awakenings (PSG)(Baseline and after 12-weeks.)
- Wake after sleep onset, duration of wake periods (PSG)(Baseline and after 12-weeks.)
Investigators
Jimmi Nielsen
Professor
Copenhagen University Hospital, Hvidovre