The overall purpose with this investigation is to further our knowledge about cognitive behavioral therapy (CBT) for insomnia by examining treatment components, mediators, and moderators. The first aim that will be addressed is to explore the efficacy of the CBT components with a dismantling-treatment strategy. Two active CBT interventions, intended to define its components - cognitive therapy and behavior therapy - will be compared with one another as well as with a waitlist condition on a broad range of outcomes at five to nine assessment points depending on the measures. The design will thus enable us to examine what CBT component or components are necessary, sufficient and facilitative of therapeutic change. The second aim that will be explored is to investigate what processes occur in CBT that may contribute to treatment outcome with a treatment-mediator strategy. To examine mediators for CBT, the following mediators will be assessed; Anxiety and Preoccupation about sleep Questionnaire (APSQ), Dysfunctional Beliefs and Attitudes about Sleep (DBAS), Sleep Associated Monitoring Index (SAMI), Sleep-Related Behavior Questionnaire (SRBQ), time in bed, napping, bedtime variability, and rise time variability. The hypothesis is that cognitive processes will mediate cognitive therapy outcomes, and that behavioral factors will have a mediating role for behavior therapy improvements. The third aim that will be addressed is to examine what patient characteristics does CBT depend on to be effective with a treatment-moderator strategy. To investigate moderators for CBT, the following moderators will be assessed; age, gender, occupational status, level of education, initial insomnia severity, dysfunction, medication use, chronic pain, psychiatric co-morbidity, medical co-morbidity, behavioral and cognitive processes used as mediators will also be employed as moderators.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
219
Cognitive Therapy involves challenging negative automatic thoughts about sleep and the use of behavioral experiments to challenge and test five cognitive processes (i.e., worry, dysfunctional thoughts, monitoring, safety behaviours, misperception) proposed to perpetuate insomnia.
Behavior Therapy involves the use of stimulus control and sleep restriction in order to reverse maladaptive sleep habits (time in bed, napping, bedtime variability, rise time variability) proposed to maintain insomnia. It also involves the practice of sleep hygiene principles.
The waitlist serves as a passive control which will receive the same measures administered to the cognitive and behaviour therapy groups.
Stockholm University
Stockholm, Sweden
Changes on the insomnia severity index (ISI).
Time frame: Pretreatment (week 0), during treatment (i.e., at week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
Changes on the Work and Social Adjustment Scale (WSAS).
Time frame: Pretreatment (week 0), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
Changes in sleep onset latency (SOL).
Time frame: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10).
Changes in wake time after sleep onset (WASO).
Time frame: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10).
Changes in early morning awakenings (EMA).
Time frame: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10).
Changes in total sleep time (TST).
Time frame: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10).
Changes in Hospital Anxiety and Depression Scale (HADS)
Time frame: Pretreatment (week 0), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
Changes in nighttime symptoms, by using item 1 - 3 from the primary outcome measure.
Time frame: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
Changes in impairment, by using item 5 and 6 from the primary outcome measure.
Time frame: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
Changes in distress, by using item 4 and 7 from the primary outcome measure.
Time frame: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
Changes in Brunnsviken Brief Quality of life index (BBQ)
Time frame: Pretreatment (week 0), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
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