Clinical trial NCT06600516: Assessing Modified CBTi in Adults with Insomnia Disorder
Official title: Minimal Intervention Necessary for Change: a Pilot Randomized Clinical Trial Modifying Cognitive Behavioral Therapy for Insomnia to Improve Sleep and Cognitive Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia Disorder
Cognitive Functioning
Keywords: Modified CBTi
Adults
Insomnia Disorder
Cognitive Functioning
Lead sponsor: Idaho State University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot randomized clinical trial with 4 treatment groups: stimulus control, sleep restriction, sleep compression, waitlist control
Primary purpose: TREATMENT

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 U.S. 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, Alzheimer's disease, and faster genetic and brain aging. Moreover, in patients with Alzheimer's 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 Alzheimer's 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, Alzheimer's 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.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age;
* Seeking treatment for an insomnia complaint, assessed by self-report;
* Stable on any prescribed, non-sedating medications (≥ 1 month), assessed by self-report and structured clinical interview

Exclusion Criteria:

* Inability to speak and read English;
* Moderate to severe brain damage, assessed by the MoCA;
* Inability to attend weekly therapy sessions either in-person or via telehealth;
* Pregnancy, assessed by self-report, because sleep disturbances due to pregnancy may be the result of different processes;
* Other untreated sleep disorders (e.g., sleep apnea, periodic limb movement disorder), assessed by clinical interview. Participants meeting criteria for a sleep disorder requiring intervention will be referred for care through the local Medical Centers or their preferred sleep disorders center.

Primary outcomes:
measure: Sleep Efficiency
timeFrame: Baseline, Week 8, 1 Month Follow Up
measure: Insomnia Severity
timeFrame: Baseline, Weeks 1-6 of treatment, Week 8, 1 Month Follow Up
measure: Multidimensional Sleep Health
timeFrame: Baseline, Weeks 1-6 of treatment, Week 8, 1 Month Follow Up
Secondary outcomes:
measure: Cognitive Functioning
timeFrame: Baseline, Week 8
Other outcomes:
measure: Improvements in Subjective Sleep
timeFrame: Baseline, Weeks 1-6 of treatment, Week 8, 1 Month Follow Up
measure: Improvements in Objective Sleep
timeFrame: Baseline, Week 8
measure: Treatment Adherence and Attendance
timeFrame: Weeks 1-6 of treatment
Locations:
city: Pocatello
country: United States
facility: Idaho State University Psychology Clinic
state: Idaho
Study officials:
affiliation: Idaho State University
name: Sarah Emert
role: PRINCIPAL_INVESTIGATOR
References: