Cognitive Behavioral Therapy for Insomnia
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Idaho State University
Must not be taking: Sedating medications
Disqualifiers: Brain damage, Pregnancy, Untreated sleep disorders, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must be stable on any prescribed, non-sedating medications for at least one month before participating.
What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Insomnia (CBTi)?
Research shows that Cognitive Behavioral Therapy for Insomnia (CBTi) is an effective treatment for insomnia, with strong evidence supporting its use as a first-line treatment. It has been shown to improve sleep onset, reduce wakefulness after sleep, and enhance overall sleep quality, with benefits that last longer than those from sleep medications.
12345Is Cognitive Behavioral Therapy for Insomnia (CBTi) safe for humans?
Cognitive Behavioral Therapy for Insomnia (CBTi) is considered a safe treatment for insomnia, with strong empirical support and recognition as a standard treatment by health organizations. It is a non-drug approach that avoids the adverse effects associated with medication.
12346How is the treatment Cognitive Behavioral Therapy for Insomnia (CBTi) unique compared to other treatments for insomnia?
Cognitive Behavioral Therapy for Insomnia (CBTi) is unique because it focuses on changing sleep-related behaviors and thoughts, rather than using medication. It is recognized as the first-line treatment for chronic insomnia and can be delivered in various ways, including online, making it more accessible to people who may not have access to trained therapists.
23678Eligibility Criteria
This trial is for adults with insomnia disorder, aiming to improve their sleep and cognitive functioning. Participants should have a diagnosis of insomnia and be interested in non-medication therapy. Those currently on sedatives or with inconsistent treatment histories may not qualify.Inclusion Criteria
I am seeking help for my trouble sleeping.
I have been on the same non-sedating medication for at least a month.
I am 18 years old or older.
Exclusion Criteria
Inability to speak and read English
Moderate to severe brain damage, assessed by the MoCA
I cannot attend weekly therapy sessions, neither in-person nor online.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Waitlist Control
Participants assigned to the waitlist control group will wait 4 weeks before starting treatment, maintaining their regular schedule
4 weeks
1 visit (in-person) for post-waitlist assessment
Treatment
Participants receive modified Cognitive Behavioral Therapy for Insomnia (CBTi) to improve sleep and cognitive function
6 weeks
Weekly sessions (in-person or virtual)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
1 visit (in-person) at 1 month follow-up
Participant Groups
The study tests modified Cognitive Behavioral Therapy for Insomnia (CBTi), which includes techniques like stimulus control, sleep restriction, and sleep compression. It's designed to see if these methods can help people sleep better without medication and potentially protect against cognitive decline.
4Treatment groups
Active Control
Group I: Waitlist ControlActive Control1 Intervention
Waitlist Control. Those randomly assigned to the WLC group will be told that they must wait 4 weeks for treatment, which is a fraction of the typical wait period in routine clinical care. During this time the participants are asked to maintain their regular schedule. At the end of 4 weeks, they will complete the baseline assessments again, which will serve as the post-waitlist assessment and then scheduled with a clinician to receive CBTi.
Group II: Stimulus ControlActive Control1 Intervention
Stimulus control.45 People with insomnia may fail to associate the bedroom with sleep, and instead may associate it with worrying, planning, or recreation. Stimulus control includes the following instructions: (1) go to bed only when sleepy; (2) only use your bed or bedroom for sleep (or sex); (3) if you do not fall asleep quickly (i.e., 15 minutes), leave the bed, do something in another room, and return to bed only when you feel a strong sleep urge; (4) if you do not fall asleep quickly upon returning to bed, repeat instruction 3; (5) use your alarm to awaken at the same time every morning regardless of duration of sleep obtained; and (6) do not take long naps.
Group III: Sleep RestrictionActive Control1 Intervention
Sleep restriction.46 People with insomnia often spend too much time awake in bed. Sleep restriction modifies the participant's sleep window so total time in bed is no more than 30 minutes beyond their average total sleep time to consolidate sleep, thus improving depth, continuity, and consistency. As the participant's sleep efficiency improves with treatment (i.e., the percentage of total time spent asleep within the sleep window), their sleep window is also increased. However, the shortened sleep window often causes increased anxiety.
Group IV: Sleep CompressionActive Control1 Intervention
Sleep compression.47,48 Sleep compression encourages time-in-bed restrictions. Unlike sleep restriction, sleep compression allows a gradual reduction in time-in-bed over the course of multiple weeks. Typically, average total sleep time and total time in bed values are calculated from one or more weeks of daily sleep diaries. The difference between these two values is then divided by the number of weeks remaining and the allotted time in bed duration is compressed by this calculated value weekly, by delaying bedtime or advancing wake time.
CBTi: Sleep Compression Core is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Cognitive Behavioral Therapy for Insomnia for:
- Insomnia disorder
- Chronic insomnia
🇪🇺 Approved in European Union as Cognitive Behavioural Therapy for Insomnia for:
- Insomnia disorder
- Chronic insomnia
🇨🇦 Approved in Canada as Cognitive Behavioral Therapy for Insomnia for:
- Insomnia disorder
- Chronic insomnia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Idaho State University Psychology ClinicPocatello, ID
Loading ...
Who Is Running the Clinical Trial?
Idaho State UniversityLead Sponsor
References
Cognitive Behavioral Therapy in the Treatment of Insomnia. [2018]Insomnia disorder is present in as much as 30% of the general adult population. Given the significant adverse effects of pharmacotherapy, cognitive behavioral therapy (CBT) has been found to be an effective alternative in individuals with insomnia. CBT for insomnia (CBTi) encompasses sleep hygiene, stimulus control, sleep restriction, cognitive therapy, and relaxation training. In this article we review evidence that establishes CBTi as a useful treatment affecting remission, sleep onset latency, wakefulness after sleep, sleep efficiency, and sleep quality in adults with insomnia to include older adults and adolescents. In addition, we briefly highlight various CBTi delivery methods as well as barriers to accessing this safe and effective therapy.
New developments in cognitive behavioral therapy as the first-line treatment of insomnia. [2022]Insomnia is the most common sleep disorder. Psychological, behavioral, and biological factors are implicated in the development and maintenance of insomnia as a disorder, although the etiology of insomnia remains under investigation, as it is still not fully understood. Cognitive behavioral therapy for insomnia (CBTI) is a treatment for insomnia that is grounded in the science of behavior change, psychological theories, and the science of sleep. There is strong empirical evidence that CBTI is effective. Recognition of CBTI as the first-line treatment for chronic insomnia (National Institutes of Health consensus, British Medical Association) was based largely on evidence of its efficacy in primary insomnia. The aim of this article is to provide background information and review recent developments in CBTI, focusing on three domains: promising data on the use of CBTI when insomnia is experienced in the presence of comorbid conditions, new data on the use of CBTI as maintenance therapy, and emerging data on the delivery of CBTI through the use of technology and in primary care settings.
Brief Behavioral Treatment of Insomnia. [2019]Cognitive behavioral treatment for insomnia (CBTI) is an effective treatment of insomnia; however, there are insufficient CBTI providers for the 10% to 25% of the population who have insomnia. Brief behavioral treatment for insomnia (BBTI) is a 4-session manualized treatment paradigm administrable in medical settings by nonpsychologist health professionals. BBTI is effective in reducing symptoms of insomnia, such as sleep onset latency, wake after sleep onset, and sleep efficiency. In some cases, BBTI resulted in full remission from insomnia. Ongoing clinical trials are further testing the efficacy of BBTI using alternative treatment deliveries and in primary medical care settings.
Insomnia and its effective non-pharmacologic treatment. [2018]Emerging data underscores the public health and economic burden of insomnia evidenced by increased health risks; increased health care utilization; and work domain deficits (absenteeism and reduced productivity). Cognitive behavioral therapy for insomnia (CBTi) is a brief and effective non-pharmacologic treatment for insomnia that is grounded in the science of sleep medicine and the science of behavior change and psychological theory, and in direct comparisons with sleep medication in randomized control trials that demonstrate that CBTi has comparable efficacy with more durable long-term maintenance of gains after treatment discontinuation. The high level of empirical support for CBTi has led the National Institutes of Health Consensus and the American Academy of Sleep Medicine Practice Parameters to make the recommendation that CBTi be considered standard treatment. The aim of this report is to increase awareness and understanding of health care providers of this effective treatment option.
Provider-supported self-management cognitive behavioral therapy for insomnia (Tele-Self CBTi): Protocol for a randomized controlled trial. [2023]Cognitive Behavioral Therapy for Insomnia (CBTi) is recommended as first-line treatment for insomnia, yet patient access to CBTi is limited. Self-help CBTi could increase patient access. Self-help CBTI with provider sup]port is more effective and is preferred by patients. Self-help CBTi has not been evaluated in veterans; a population with greater medical and mental health morbidity and more severe sleep difficulties than non-veterans. Moreover, those with mental health conditions have been largely excluded from prior CBTi self-help trials. Stablishing the efficacy of provider-supported Self-help CBTi is an important first step for expanding veteran access to CBTi.
The Anxiolytic Effects of Cognitive Behavior Therapy for Insomnia: Preliminary Results from a Web-delivered Protocol. [2022]Though the efficacy of cognitive behavior therapy for insomnia (CBTI) is well-established, the paucity of credentialed providers hinders widespread access. Further, the impact of alternatives such as web-delivered CBTI has not been adequately tested on common insomnia comorbidities such as anxiety. Therefore, we assessed the impact of an empirically validated web-delivered CBTI intervention on insomnia and comorbid anxiety symptoms. A sample of 22 adults (49.8±13.5 yo; 62.5% female) with DSM-5 based insomnia were randomized to either an active CBTI treatment group (n = 13) or an information-control (IC) group (n = 9). Participants in the CBTI group underwent a standard CBTI program delivered online by a 'virtual' therapist, whereas the IC group received weekly 'sleep tips' and general sleep hygiene education via electronic mail. All participants self-reported sleep parameters, including sleep onset latency (SOL), insomnia symptoms per the Insomnia Severity Index (ISI), and anxiety symptoms per the Beck Anxiety Inventory (BAI) at both baseline as well as follow- up assessment one week post-treatment. There were no significant differences between the CBTI and IC groups on baseline measures. The CBTI group showed significantly larger reductions in BAI scores (t = 2.6; p
[Cognitive-behavioral therapy and pharmacotherapy for chronic insomnia]. [2019]Cognitive-behavioral therapy for insomnia (CBT-I) is the treatment of choice for chronic insomnia. Together with advantages it has such limitations like shortage of trained staff and low response rate. That is why the alternative methods of CBT-I induce high interest: bibliotherapy, phone psychotherapy, brief behavioral therapy and online-CBT-I. Hypnotics administration is recommended as adjuvant to extent the CBT-I effect. It may also be used as monotherapy when CBT-I is unavailable.
In-person and telehealth treatment of veterans with insomnia disorder using cognitive behavioral therapy for insomnia during the COVID-19 pandemic. [2023]Cognitive behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment for insomnia disorder. The goal of this study was to evaluate clinical benefits of CBT-I to veterans with insomnia disorder during the early months of the COVID-19 pandemic using an uncontrolled observational design.