Insomnia
Conditions
Brief summary
The present study examines the short- and long-term clinical efficacy of cognitive-behavior therapy and pharmacological treatment in patients suffering from late-life primary insomnia. 46 subjects suffering from chronic primary insomnia were randomized into either cognitive-behavior therapy (CBT, n=18), hypnotics (7.5 mg Zopiclone, n=16), or placebo treatment (n=12). All active treatments lasted 6 weeks with follow-ups conducted at 6 months. Ambulant clinical polysomnography (PSG) and sleep diaries were used on all three assessment points.
Interventions
BEHAVIORALCognitive behavior therapy (CBT)
DRUGZopiclone
Sponsors
University of Bergen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* age 55 years or older * fulfilment of the DMS-IV criteria for insomnia, including difficulties initiating sleep, maintaining sleep, and/or early morning awakenings with no ability of return to sleep * duration of at least 3 months * complaints of impaired daytime functioning.
Exclusion criteria
* use of hypnotic medication the last 4 weeks before project start * use of antidepressive or antipsychotic medications * signs of dementia or other serious cognitive impairment defined by a score under 25 on the Mini-Mental State Examination * presence of a major depressive disorder or other severe mental disorder as identified by a clinical assessment based on The Structured Clinical Interview for DSM-IV (SCID-I) * presence of sleep apnea defined as (A/H index \> 15) or periodic limb movements during sleep (PLM index with arousal \> 15), * working nightshifts and unable or unwilling to discontinue this work pattern, * willingness or inability to stop taking sleep medication before start * having a serious somatic conditions preventing further participation
Countries
Norway
Outcome results
None listed