Assessing Modified CBTi in Adults With Insomnia Disorder

Running, not enrolling · Not applicable

Conditions studied: Insomnia Disorder, Cognitive Functioning

In brief

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. However, CBTi is underutilized, training is limited, and medical professionals are implementing treatment approaches inconsistent with empirically supported guidelines. 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. The proposed project will include two primary aims in establishing a foundation needed to examine individual benefits of the components of CBTi. 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.

Key facts

Study ID

NCT06600516

Run by

Idaho State University

People needed

37

Starts

2024-09-06

Expected to finish

2026-06-01

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age;
• Seeking treatment for an insomnia complaint, assessed by self-report;
• Probable insomnia disorder, assessed by the SCI, total score ≤ 16;
• Stable on any prescribed, non-sedating medications (≥ 1 month), assessed by self-report and structured clinical interview;
• Access to an Apple iPhone or iPad (iOS needed for daily sleep diaries app)

You may not qualify if…

• Inability to speak and read English;
• Moderate to severe brain damage/cognitive impairment, assessed by the MoCA. total score < 18;
• Inability to follow research protocol (e.g., cannot attend weekly therapy sessions, no-show for appointments, consistent failure to complete assessments, unwillingness to do home sleep study);
• Refraining from participation in other behavioral health treatment or medication(s) during participation (unless prescribed/referred by provider);
• High risk for suicide within the past 3 months, assessed by C-SSRS
• Diagnosed with a serious mental illness (i.e., psychotic disorder, bipolar disorder);
• Current 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), 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.);
• Residence >30 min driving time from university campus

Where it is running

• Idaho State University Psychology Clinic — Pocatello, Idaho, United States

Full record on ClinicalTrials.gov

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