Assessing Modified CBTi in Adults with Insomnia Disorder

NCT06600516 | Recruiting

• 1 other identifier: IRB-FY2024-124
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Disorder; Cognitive Functioning

Keywords

Modified CBTi; Adults; Insomnia Disorder; Cognitive Functioning

Outcome Measures

Primary Outcomes (3)

• Sleep Efficiency

  Sleep efficiency represents a ratio of total sleep time and total time in bed. Measured 0-100% with higher percentages indicating better sleep efficiency.

  Baseline, Week 8, 1 Month Follow Up

• Insomnia Severity

  Insomnia severity measured by the Insomnia Severity Index. Measured 0-28 with higher scores indicating worse insomnia severity.

  Baseline, Weeks 1-6 of treatment, Week 8, 1 Month Follow Up

• Multidimensional Sleep Health

  RU-SATED will be used to assess sleep health among adults. Measured 0-12 with higher scores indicating better sleep health.

  Baseline, Weeks 1-6 of treatment, Week 8, 1 Month Follow Up

Secondary Outcomes (1)

• Cognitive Functioning

  Baseline, Week 8

Other Outcomes (3)

• Improvements in Subjective Sleep

  Baseline, Weeks 1-6 of treatment, Week 8, 1 Month Follow Up

• Improvements in Objective Sleep

  Baseline, Week 8

• Treatment Adherence and Attendance

  Weeks 1-6 of treatment

Study Arms (4)

Stimulus Control

ACTIVE COMPARATOR

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.

Behavioral: CBTi: Stimulus Control Core

Sleep Restriction

ACTIVE COMPARATOR

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.

Behavioral: CBTi: Sleep Restriction Core

Sleep Compression

ACTIVE COMPARATOR

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.

Behavioral: CBTi: Sleep Compression Core

Waitlist Control

NO 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.

Interventions

CBTi: Stimulus Control Core BEHAVIORAL

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.

Stimulus Control

CBTi: Sleep Restriction Core BEHAVIORAL

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.

Sleep Restriction

CBTi: Sleep Compression Core BEHAVIORAL

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.

Sleep Compression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Idaho State University: lead

Study Sites (1)

Idaho State University Psychology Clinic

Pocatello, Idaho, 83201, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Sarah Emert

  Idaho State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Emert

CONTACT

208-282-1221; sarahemert@isu.edu

Cordell Stover

CONTACT

cordellstover@isu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot randomized clinical trial with 4 treatment groups: stimulus control, sleep restriction, sleep compression, waitlist control

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: September 6, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)