Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600516
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Assessing Modified CBTi in Adults with Insomnia Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Minimal Intervention Necessary for Change a Pilot Randomized Clinical Trial Modifying Cognitive Behavioral Therapy for Insomnia to Improve Sleep and Cognitive Function
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sleep is a biological need crucial for maintaining overall health and resiliency Sleep disorders disrupt this normal functioning Insomnia disorder is the most prevalent sleep disorder and yields costs to the US Healthcare System in billions of dollars per year Chronic insomnia has been linked to numerous physical and psychological health outcomes as well as increased mortality
There is also evidence that insomnia is a risk factor for worse inflammation worse neurological functioning cognitive performance and mild cognitive impairment including cognitive decline Alzheimers disease and faster genetic and brain aging Moreover in patients with Alzheimers disease those with insomnia showed a faster progression to dementia Better sleep health provides neuroprotection against this decline Impairment in objective and subjective cognitive performance highlights the utility of treating insomnia to potentially improve cognitive outcomes during midlife and insomnia symptoms are a modifiable risk factor for cognitive decline mild cognitive impairment and Alzheimers disease and related dementia
Cognitive Behavioral Therapy for Insomnia CBTi is the gold-standard first line recommended treatment for insomnia and has considerably better long-term outcomes than medications CBTi decreases insomnia symptom severity by 50 CBTi also appears to improve cognitive functioning However CBTi is underutilized training is limited and medical professionals are implementing treatment approaches inconsistent with empirically supported guidelines Insomnia symptoms are being inadequately treated while misinformation and misconceptions about insomnia disorder CBTi and actual therapeutic effects are being propagated Moreover sedating medications are currently the most commonly used treatment for insomnia which is problematic because the potential side effects can have major implications for the aging population Additionally some patients continue to experience insomnia symptoms even when taking sleep medication which can lead to increase dosages dependence on and tolerance to these medications further emphasizing the importance of CBTi There is also a need for more readily accessible short-term modified treatments for insomnia disorder A modified format of CBTi may assist in dissemination of effective treatments while also providing the potential for adapting this treatment to specific client characteristics To address this need we will modify CBTi and conduct a pilot randomized clinical trial to test these modifications
The proposed project will include two primary aims in establishing a foundation needed to examine individual benefits of the components of CBTi These aims will aid in the continuation of investigation to better assess treatment outcomes create transdiagnostic treatment plans and provide individualized health care through accessible psychotherapy Obtaining a better understanding of the predictors of successful treatment may improve our understanding of the underlying mechanisms of successful treatment Ultimately this improved understanding may help to improve treatment for insomnia disorder improve cognitive functioning and potentially reduced risk for cognitive decline associated with mild cognitive impairment Alzheimers disease and related dementias Improved treatment outcomes utilizing specific core components of CBTi may result in improvements of insomnia disorder and cognitive functioning and would provide a major step forward in understanding the mechanisms underlying the etiology and maintenance of insomnia as well as how risks associated with mild cognitive impairment and cognitive decline might be mitigated Lastly this proposed project allows for proof of concept and for collaborations to be made within the medical and mental health communities in Pocatello ID and surrounding areas decreasing barriers to treatment and improving treatment dissemination
There is also evidence that insomnia is a risk factor for worse inflammation worse neurological functioning cognitive performance and mild cognitive impairment including cognitive decline Alzheimers disease and faster genetic and brain aging Moreover in patients with Alzheimers disease those with insomnia showed a faster progression to dementia Better sleep health provides neuroprotection against this decline Impairment in objective and subjective cognitive performance highlights the utility of treating insomnia to potentially improve cognitive outcomes during midlife and insomnia symptoms are a modifiable risk factor for cognitive decline mild cognitive impairment and Alzheimers disease and related dementia
Cognitive Behavioral Therapy for Insomnia CBTi is the gold-standard first line recommended treatment for insomnia and has considerably better long-term outcomes than medications CBTi decreases insomnia symptom severity by 50 CBTi also appears to improve cognitive functioning However CBTi is underutilized training is limited and medical professionals are implementing treatment approaches inconsistent with empirically supported guidelines Insomnia symptoms are being inadequately treated while misinformation and misconceptions about insomnia disorder CBTi and actual therapeutic effects are being propagated Moreover sedating medications are currently the most commonly used treatment for insomnia which is problematic because the potential side effects can have major implications for the aging population Additionally some patients continue to experience insomnia symptoms even when taking sleep medication which can lead to increase dosages dependence on and tolerance to these medications further emphasizing the importance of CBTi There is also a need for more readily accessible short-term modified treatments for insomnia disorder A modified format of CBTi may assist in dissemination of effective treatments while also providing the potential for adapting this treatment to specific client characteristics To address this need we will modify CBTi and conduct a pilot randomized clinical trial to test these modifications
The proposed project will include two primary aims in establishing a foundation needed to examine individual benefits of the components of CBTi These aims will aid in the continuation of investigation to better assess treatment outcomes create transdiagnostic treatment plans and provide individualized health care through accessible psychotherapy Obtaining a better understanding of the predictors of successful treatment may improve our understanding of the underlying mechanisms of successful treatment Ultimately this improved understanding may help to improve treatment for insomnia disorder improve cognitive functioning and potentially reduced risk for cognitive decline associated with mild cognitive impairment Alzheimers disease and related dementias Improved treatment outcomes utilizing specific core components of CBTi may result in improvements of insomnia disorder and cognitive functioning and would provide a major step forward in understanding the mechanisms underlying the etiology and maintenance of insomnia as well as how risks associated with mild cognitive impairment and cognitive decline might be mitigated Lastly this proposed project allows for proof of concept and for collaborations to be made within the medical and mental health communities in Pocatello ID and surrounding areas decreasing barriers to treatment and improving treatment dissemination
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None