Sleep Intervention + CBT for Insomnia

Overseen By Catherine Siengsukon, PT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Must not be taking: Benzodiazepines, Melatonin, others

Disqualifiers: Sleep apnea, Severe depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 6 weeks

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a sleep improvement program for older adults with insomnia. It aims to see if better sleep can enhance memory and reduce brain changes related to Alzheimer's disease.

Will I have to stop taking my current medications?

If you are currently taking medications like benzodiazepines, non-benzodiazepines, melatonin supplements, or agonists for insomnia, you will need to stop taking them to participate in this trial.

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Insomnia (CBT-I)?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective for improving sleep quality and reducing the need for sleep medications. It is considered the first-line treatment for both simple insomnia and insomnia that occurs alongside other chronic conditions. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy for Insomnia (CBT-I) safe for humans?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered safe and is recommended as the first-line treatment for insomnia, without the risks associated with sleeping medications. ^{3 4 6 7 8}

How is the treatment Cognitive Behavioral Therapy for Insomnia (CBT-I) unique compared to other treatments for insomnia?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is unique because it is a non-drug treatment that addresses the underlying behaviors and thoughts contributing to insomnia, making it the first-line treatment for both simple and complex cases of insomnia. Unlike medications, CBT-I involves techniques like sleep restriction, stimulus control, and cognitive therapy, and can be delivered in various formats, including workshops and online sessions, to overcome barriers like cost and access to trained clinicians. ^{3 4 9 10 11}

Research Team

Catherine Siengsukon, PT, PhD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

Adults aged 60-85 with insomnia symptoms, who have trouble sleeping at least three nights a week for six months and score high enough on mental state exams to show no severe cognitive impairment or dementia. Excluded are those with untreated sleep disorders, severe depression, substance abuse history, certain mental illnesses or learning disabilities, current shift workers, or those already in CBT-I treatment.

Inclusion Criteria

I have had trouble sleeping at least three nights a week for the past six months.

You have a score of 10 or more on the Insomnia Severity Index.

You have a score of 25 or higher on the Mini-Mental State Examination (MMSE).

Exclusion Criteria

You have had trouble learning or paying attention in the past.

I am currently taking medication or supplements for sleep problems.

I have an untreated sleep disorder like sleep apnea or restless leg syndrome.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo a six-week sleep intervention program, including CBT-I or Sleep and Lifestyle Education

6 weeks

6 sessions (in-person)

Follow-up

Participants are monitored for changes in cognitive function and Aβ deposition

1 year

Reassessments at 6 weeks and 1 year

Treatment Details

Interventions

• Cognitive Behavioral Therapy for Insomnia (CBT-I)
• Sleep and Lifestyle Education

Trial Overview The trial is testing whether a six-week program of Sleep and Lifestyle Education combined with Cognitive Behavioral Therapy for Insomnia (CBT-I) can improve cognitive function and reduce brain amyloid deposits in older adults with insomnia. Some participants will also undergo PET imaging to track changes in amyloid levels over one year.

Participant Groups

Group I: Six-Week CBT-I Program Experimental Treatment 1 Intervention

CBT-I, six sessions, forty-five to sixty minutes in duration. Session 1: set up sleep restriction and stimulus control, discuss strategies for how to stay awake to a prescribed hour and what to do with wake after onset sleep time, provide sleep hygiene education. Session 2: determine if upward titration of total sleep time is warranted, review sleep hygiene. Session 3: continue upward titration of total sleep time, cognitive therapy for negative sleep beliefs if indicated. Session 4: continue upward titration of total sleep time, follow-up regarding negative sleep beliefs. Session 5: continue upward titration of total sleep time, discuss relapse prevention. Session 6: assess global treatment gains, discuss questions regarding relapse prevention.

Group II: Six-Week Sleep and Lifestyle Education Program Active Control 1 Intervention

Sleep and Lifestyle Education, six sessions, forty-five to sixty minutes in duration. Session 1: Sleep education, Instruction/demonstration on stretching exercises. Session 2: Education on environmental factors \& sleeping positions that impact sleep. Session 3: Education on lifestyle factors that impact sleep. Session 4: Education on diet and sleep. Session 5: Education on exercises and sleep. Session 6: Discus maintaining achievements \& preventing relapses.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

Cognitive behavioral therapy for insomnia (CBT-I) was effective in improving insomnia symptoms over a 24-month follow-up among 59 media workers, with 62% of participants showing moderate improvement.

The study found that working hour arrangements did not impact the effectiveness of CBT-I, indicating that this treatment can benefit both daytime and shift workers with chronic insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for chronic insomnia in occupational health services: analyses of outcomes up to 24 months post-treatment. Järnefelt, H., Sallinen, M., Luukkonen, R., et al.[2018]

Cognitive-behavioral therapy for insomnia (CBT-I) significantly improved sleep in patients with chronic insomnia, with 46% achieving normal sleep ratings after 5 sessions, compared to those receiving standard treatment.

Despite the sleep improvements, CBT-I did not lead to changes in depression, anxiety, or quality of life, and none of the patients chose to stop their hypnotic medications, indicating that while CBT-I can enhance sleep, it may not address broader mental health issues in patients with severe psychiatric conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a CBT Intervention for Persistent Insomnia and Hypnotic Dependency in an Outpatient Psychiatry Clinic. Taylor, HL., Rybarczyk, BD., Nay, W., et al.[2022]

Cognitive behavioral therapy for insomnia (CBT-I) is recognized as the first-line treatment for both uncomplicated insomnia and insomnia associated with other chronic disorders, demonstrating its broad efficacy.

This review aims to summarize efficacy data across various clinical and demographic factors and to outline future research and implementation strategies for CBT-I, highlighting its importance in treating sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

We know CBT-I works, now what? Muench, A., Vargas, I., Grandner, MA., et al.[2022]

Cognitive Behavioral Therapy for Insomnia (CBT-I) is an effective multi-component treatment for chronic insomnia, which affects 6-10% of the population and can lead to various health issues; it is recommended as the first-line intervention for insomnia.

Despite its proven efficacy and comprehensive evidence base, CBT-I is not widely disseminated, highlighting the need for increased awareness and training among clinicians and researchers to improve treatment access for those suffering from insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia (CBT-I): A Primer. Walker, J., Muench, A., Perlis, ML., et al.[2023]

Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly improved sleep quality, sleep onset, and sleep efficiency in 76 patients with primary insomnia over a 6-week group course in a clinical setting.

CBT-I also led to reductions in medication use and improvements in patients' overall health and cognitive functioning, highlighting its effectiveness beyond just sleep improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioural therapy for primary insomnia: effectiveness in a clinical setting]. Van Houdenhove, L., Buyse, B., Gabriels, L., et al.[2018]

Cognitive behavioral therapy for insomnia (CBT-I) is a safe and effective alternative to sleeping medications, but many patients are unaware or reluctant to engage with it, preferring sedative hypnotics instead.

Focus groups with 29 Veterans revealed that patients prefer a stepped-care approach to CBT-I, starting with self-management tools and progressing to provider-delivered therapy if necessary, highlighting the need for multiple outreach efforts and delivery options to increase engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Sign Me Up, I'm Ready!": Helping Patients Prescribed Sleeping Medication Engage with Cognitive Behavioral Therapy for Insomnia (CBT-I). Koffel, E., Branson, M., Amundson, E., et al.[2021]

Cognitive-behavioral therapy for insomnia (CBT-I) is recommended as the first-line treatment for chronic primary insomnia, which affects about 10% of adults and is associated with various health risks.

There is ongoing research into extending CBT-I to patients with insomnia related to medical and psychiatric conditions, but there is currently no consensus on the criteria for determining suitable candidates for this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Who is a candidate for cognitive-behavioral therapy for insomnia? Smith, MT., Perlis, ML.[2022]

A web-delivered cognitive behavior therapy for insomnia (CBTI) program significantly reduced anxiety and insomnia symptoms in a study of 22 adults, demonstrating its efficacy as a treatment option.

Participants in the CBTI group experienced greater improvements in sleep onset latency and overall sleep quality compared to those receiving general sleep hygiene information, suggesting that online CBTI can effectively address insomnia and its comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Anxiolytic Effects of Cognitive Behavior Therapy for Insomnia: Preliminary Results from a Web-delivered Protocol. Pillai, V., Anderson, JR., Cheng, P., et al.[2022]

A single 4-hour group workshop on cognitive behavioral treatment for insomnia (CBT-I) significantly improved insomnia symptoms in 45 participants, with Insomnia Severity Index scores dropping from an average of 20.09 to 11.89 after one month.

Participants also reported a reduction in sleep aid use, with 80% indicating better sleep quality and 20% achieving remission of insomnia, highlighting the effectiveness of this accessible treatment format.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of Insomnia Symptoms following a Single 4-Hour CBT-I Workshop. Okun, ML., Glidewell, RN.[2023]

Cognitive-behavioral therapy for insomnia (CBT-I) is the preferred treatment for chronic insomnia, but it faces challenges such as a lack of trained therapists and a low response rate among patients.

Alternative methods to CBT-I, including bibliotherapy, phone psychotherapy, brief behavioral therapy, and online CBT-I, are gaining interest, and hypnotics can be used alongside CBT-I to enhance its effectiveness or as a standalone treatment when CBT-I is not accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioral therapy and pharmacotherapy for chronic insomnia]. Pchelina, PV., Poluektov, MG.[2019]

Cognitive behavioral therapy for insomnia (CBT-I) significantly improves insomnia symptoms, with 36% of patients achieving remission compared to only 16.9% in control groups, indicating its efficacy for those with comorbid conditions.

CBT-I shows medium to large effect sizes for various sleep parameters, such as sleep efficiency and sleep onset latency, and has a small positive effect on comorbid symptoms, particularly benefiting patients with psychiatric conditions more than those with medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. Wu, JQ., Appleman, ER., Salazar, RD., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for chronic insomnia in occupational health services: analyses of outcomes up to 24 months post-treatment. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a CBT Intervention for Persistent Insomnia and Hypnotic Dependency in an Outpatient Psychiatry Clinic. [2022]

3. England pubmed.ncbi.nlm.nih.gov

We know CBT-I works, now what? [2022]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia (CBT-I): A Primer. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioural therapy for primary insomnia: effectiveness in a clinical setting]. [2018]

6. England pubmed.ncbi.nlm.nih.gov

"Sign Me Up, I'm Ready!": Helping Patients Prescribed Sleeping Medication Engage with Cognitive Behavioral Therapy for Insomnia (CBT-I). [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Who is a candidate for cognitive-behavioral therapy for insomnia? [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The Anxiolytic Effects of Cognitive Behavior Therapy for Insomnia: Preliminary Results from a Web-delivered Protocol. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Improvement of Insomnia Symptoms following a Single 4-Hour CBT-I Workshop. [2023]

10. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioral therapy and pharmacotherapy for chronic insomnia]. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. [2022]