Sleep Initiation and Maintenance Disorders Clinical Trial
Official title:
Cognitive Behavior Therapy for Insomnia: Analysis of Components, Mediators and Moderators
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
| Recruiting |
NCT05000528 -
Evaluation of the Effectiveness of Patient Therapeutic Education on Chronic Insomnia
|
N/A | |
| Completed |
NCT04661306 -
The Better Sleep for Supporters With Insomnia Study
|
N/A | |
| Completed |
NCT03673397 -
The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression
|
N/A | |
| Completed |
NCT01784614 -
A Study of LY2624803 in Japanese Participants With Transient Insomnia
|
Phase 1 | |
| Completed |
NCT00380003 -
Efficacy Study of EVT 201 to Treat Insomnia
|
Phase 2 | |
| Completed |
NCT00365261 -
Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer
|
Phase 4 | |
| Completed |
NCT00183378 -
Using Behavioral Programs to Treat Sleep Problems in Individuals With Alzheimer's Disease
|
N/A | |
| Completed |
NCT00946530 -
Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease
|
N/A | |
| Completed |
NCT00097604 -
Effects of Valerian on Sleep in Healthy Older Adults
|
Phase 2 | |
| Completed |
NCT00630175 -
Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia
|
Phase 3 | |
| Completed |
NCT00079664 -
Comparing Tai Chi Training to a Low-Stress Physical Activity to Enhance Sleep in Older Adults
|
Phase 1 | |
| Completed |
NCT00044629 -
Combined Behavioral/Pharmacological Therapy for Insomnia
|
Phase 2 | |
| Completed |
NCT01154023 -
Behavioral Intervention for Insomnia in Older Adults
|
N/A | |
| Recruiting |
NCT04417153 -
Who Benefits More? Optimising Mindfulness Based Interventions for Improved Psychological Outcomes
|
||
| Completed |
NCT04560595 -
Remote Guided Caffeine Reduction
|
N/A | |
| Recruiting |
NCT04986007 -
Addressing Nocturnal Sleep/Wake Effects on Risk of Suicide in Older Adults
|
N/A | |
| Completed |
NCT03852966 -
Better Sleep in Psychiatric Care - ADHD Pilot Study
|
N/A | |
| Terminated |
NCT00750919 -
Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007)
|
Phase 3 | |
| Recruiting |
NCT04550507 -
Mind-Body Interventions to Mitigate Effects of Media Use on Sleep in Early Adolescents
|
N/A |