NCT02984670

Cognitive Behavior Therapy for Insomnia: Analysis of Components, Mediators and Moderators

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: Stockholm University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Sleep Initiation and Maintenance Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Therapy	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.
BEHAVIORAL	Behavior Therapy	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.
BEHAVIORAL	Waitlist.	The waitlist serves as a passive control which will receive the same measures administered to the cognitive and behaviour therapy groups.

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2016-12-07
• Last updated: 2018-04-19

Locations

1 site across 1 country: Sweden