Improving sleep in adults with insomnia using modified cognitive behavioral therapy
Minimal Intervention Necessary for Change: a Pilot Randomized Clinical Trial Modifying Cognitive Behavioral Therapy for Insomnia to Improve Sleep and Cognitive Function
This study is testing a new way to help adults with insomnia sleep better using modified cognitive behavioral therapy techniques.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Idaho State University Academic / other |
| Locations | 1 site (Pocatello, Idaho) |
| Trial ID | NCT06600516 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of modified cognitive behavioral therapy for insomnia (CBTi) in adults suffering from insomnia disorder. The intervention includes techniques such as stimulus control, sleep restriction, and sleep compression to help participants improve their sleep quality. By addressing insomnia, the study aims to enhance cognitive functioning and overall health outcomes. Participants will be assessed for eligibility based on their insomnia complaints and cognitive health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are seeking treatment for insomnia and are stable on non-sedating medications.
Not a fit: Patients with moderate to severe brain damage, other untreated sleep disorders, or those unable to attend therapy sessions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve sleep quality and cognitive functioning in adults with insomnia.
How similar studies have performed: Previous studies have shown that cognitive behavioral therapy is effective for treating insomnia, suggesting potential success for this modified approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pocatello, Idaho
- Idaho State University Psychology Clinic — Pocatello, Idaho, United States (Recruiting)
Study contacts
- Principal investigator: Sarah Emert — Idaho State University
- Study coordinator: Sarah Emert
- Email: sarahemert@isu.edu
- Phone: 208-282-1221
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.