Cognitive Behavioral Therapy for Suicidal Thoughts in Older Adults

(ANSWERS-OA Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Michael A Grandner, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: MICHAEL A GRANDNER

Must not be taking: Psychotropics

Disqualifiers: Bipolar, Psychotic disorders, Untreated apnea, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing an online therapy to help older adults with insomnia and suicidal thoughts. The therapy aims to improve sleep by changing negative thoughts and habits around sleep. By doing so, it may also reduce suicidal thoughts and improve cognitive function.

Will I have to stop taking my current medications?

If you are taking psychotropic medications (like antidepressants or sleep aids), you must not have changed the dose in the past 6 weeks and agree not to change it during the trial. If you are not on such medications, you need to be medication-free for at least 6 weeks before starting the trial and agree not to start any new medications during the trial.

What data supports the effectiveness of the treatment Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) for suicidal thoughts in older adults?

Research shows that Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) is effective in reducing insomnia severity, improving sleep quality, and enhancing overall well-being. Additionally, it has been found to reduce symptoms of depression, anxiety, and suicidal thoughts, which suggests it may be beneficial for older adults experiencing suicidal thoughts. ^{1 2 3 4 5}

Is digital cognitive behavioral therapy for insomnia safe for humans?

Digital cognitive behavioral therapy for insomnia (dCBT-I) has been studied in various trials and is generally considered safe for humans, as it is a non-invasive treatment that focuses on improving sleep and well-being. ^{1 2 3 6 7}

How is Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) unique in treating suicidal thoughts in older adults?

Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) is unique because it is a scalable, internet-based treatment that not only addresses insomnia but also improves depression, anxiety, and suicidal thoughts, which are often linked to poor sleep. Unlike traditional therapies, dCBT-I can be accessed online, making it more accessible and convenient for older adults. ^{1 3 8 9 10}

Research Team

Michael A Grandner, PhD

Principal Investigator

University of Arizona

Eligibility Criteria

This trial is for English-speaking individuals aged 65 or older with insomnia and recent suicidal thoughts. They must be willing to share information between the research team and their mental health provider, not work night shifts, have internet access, and not plan to change psychotropic medications during the trial.

Inclusion Criteria

English speaking

All participants must consent to a release of information between the research team and their treatment provider (either their prescribing psychiatrist, their masters-level non-trainee therapist, or their doctoral-level psychologist)

I currently have trouble sleeping.

Exclusion Criteria

Cognitive impairment sufficient to impair delivery or retention of dCBT-I as indicated by the Short Blessed Test

I do not have bipolar, psychotic disorders, or other serious mental illnesses.

Life expectancy of less than 1 year as determined by record review and intake interview

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 8 weeks of digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) or are placed in a waitlist control group with weekly monitoring

8 weeks

Weekly monitoring

Crossover Treatment

Participants in the waitlist control group crossover to receive 8 weeks of dCBT-I, while those initially receiving dCBT-I undergo active monitoring

8 weeks

Weekly monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6- and 12-months post-treatment

12 months

Treatment Details

Interventions

• Digital Cognitive Behavioral Therapy for Insomnia (Behavioral Intervention)

Trial Overview The study tests digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in older adults to see if it reduces suicidal thinking. It's a preliminary investigation into whether treating sleep problems can help alleviate suicide risk factors without necessarily improving cognition.

Participant Groups

Group I: digital Cognitive Behavioral Therapy for Insomnia Experimental Treatment 1 Intervention

Following baseline evaluation, participants in this group will receive 8 weeks of digital Cognitive Behavioral Therapy for Insomnia delivered using Sleep Healthy Using the Internet (SHUTi). After the interim assessment, participants will then crossover to 8 weeks of active monitoring.

Group II: Waitlist Control Active Control 1 Intervention

Following baseline evaluation, participants in this group will undergo weekly monitoring of insomnia and suicidal ideation for 8 weeks. Participants will continue whatever treatments they are currently receiving, but will receive no specific instructions or behavioral interventions for insomnia. After the interim assessment, participants will then crossover to receive digital Cognitive Behavioral Therapy for Insomnia.

Digital Cognitive Behavioral Therapy for Insomnia is already approved in Canada for the following indications:

Approved in Canada as CBT-I for:

• Insomnia

Who Is Running the Clinical Trial?

MICHAEL A GRANDNER

Lead Sponsor

Trials

1

Recruited

70+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Dr. Joan Lau

University of Pennsylvania

Chief Executive Officer since 2020

PhD in Neuroscience from the University of Cincinnati College of Medicine, MBA from the Wharton School of Business, BS in Bioengineering from the University of Pennsylvania

Dr. Robert Iannone

University of Pennsylvania

Chief Medical Officer since 2019

MD from Yale University, MSCE from the University of Pennsylvania

Findings from Research

Digital cognitive behavioral therapy (dCBT) significantly improves functional health, psychological well-being, and sleep-related quality of life in individuals with insomnia, based on a study of 1711 participants over 24 weeks.

The reduction in insomnia symptoms was a key factor mediating these improvements, highlighting that dCBT effectively addresses both daytime and nighttime issues related to poor sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. Espie, CA., Emsley, R., Kyle, SD., et al.[2023]

Digital cognitive behavior therapy for insomnia (dCBT-I) significantly improves sleep quality in patients with insomnia, particularly in those with anxiety disorders, as shown in a study of 6,002 patients over a 12-week period.

Patients receiving dCBT-I monotherapy and those with combined therapy showed notable improvements in sleep quality, with the most significant changes observed in the anxiety group, indicating that dCBT-I is a practical and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. Liang, S., Mao, H., Yang, J., et al.[2022]

Digital cognitive behavioral therapy (dCBT) significantly improves functional health, psychological well-being, and sleep-related quality of life in adults with chronic insomnia, with these benefits sustained up to 48 weeks after treatment.

dCBT also reduces the use of both prescription and non-prescription sleep medications compared to sleep hygiene education, indicating its effectiveness in managing insomnia without relying heavily on medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term benefits of digital cognitive behavioural therapy for insomnia: Follow-up report from a randomized clinical trial. Luik, AI., Marsden, A., Emsley, R., et al.[2021]

A randomized controlled trial involving 1149 Australian adults showed that self-guided digital Cognitive Behavioral Therapy for insomnia (CBT-I) significantly improved various sleep outcomes, including sleep-onset latency and sleep quality, compared to a control program.

These improvements were not only evident immediately after the intervention but were also sustained over 18 months, highlighting the long-term effectiveness of digital CBT-I for individuals with insomnia and depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep-specific outcomes attributable to digitally delivered cognitive behavioral therapy for insomnia in adults with insomnia and depressive symptoms. Batterham, PJ., Thorndike, FP., Gerwien, R., et al.[2023]

In a study involving 1720 adults with insomnia, digital cognitive behavioral therapy for insomnia (dCBT-I) significantly reduced intraindividual variability in sleep metrics, particularly in sleep onset latency, which is crucial for improving sleep quality.

The reduction in variability in sleep metrics was found to mediate significant improvements in both insomnia severity and psychological distress, highlighting the effectiveness of dCBT-I as a therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of sleep-wake intraindividual variability in digital cognitive behavioral therapy for insomnia: a mediation analysis of a large-scale RCT. Vestergaard, CL., Vedaa, Ø., Simpson, MR., et al.[2021]

A smartphone-based, culturally adapted digital cognitive behavioral therapy for insomnia (DCBT-I) significantly reduced insomnia severity compared to sleep education in a randomized trial with 82 participants over 6 weeks.

Participants in the DCBT-I group experienced greater improvements in total sleep time and sleep efficiency at both 3 and 6 months follow-up, indicating its efficacy in enhancing sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Cognitive Behavioral Therapy for Insomnia Using a Smartphone Application in China: A Pilot Randomized Clinical Trial. Zhang, C., Liu, Y., Guo, X., et al.[2023]

A brief cognitive behavioral therapy for insomnia (CBT-I) intervention delivered by public health nurses significantly improved depressive symptoms in community-dwelling older adults, as shown by a decrease in Geriatric Depression Scale scores over a 3-month follow-up.

The study, which used a randomized controlled design with a wait-list control group, found a small effect size (Cohen's d = 0.34), indicating that while effective, the intervention's impact on depression was modest.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Brief Cognitive Behavioral Therapy for Insomnia on Improving Depression Among Community-Dwelling Older Adults: A Randomized Controlled Comparative Study. Tanaka, M., Kusaga, M., Nyamathi, AM., et al.[2022]

In a study of 144 older veterans with insomnia, cognitive behavioral therapy for insomnia (CBTI) led to significant reductions in dysfunctional sleep-related beliefs, which were linked to improvements in various sleep and daytime functioning outcomes.

The CBTI group showed stronger associations between improved sleep-related beliefs and better scores on sleep quality and fatigue measures, indicating that addressing these beliefs is crucial for enhancing the effectiveness of CBTI in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Change in Dysfunctional Sleep-Related Beliefs is Associated with Changes in Sleep and Other Health Outcomes Among Older Veterans With Insomnia: Findings From a Randomized Controlled Trial. Song, Y., Kelly, MR., Fung, CH., et al.[2022]

The internet-based cognitive-behavioral therapy for insomnia (CBT-I) program significantly reduced symptoms of depression, anxiety, and insomnia within just 4 weeks, with these improvements lasting for over 18 months in a study of 1,149 adults.

While the CBT-I program effectively lowered depressive symptoms long-term, its impact on suicidal ideation was only temporary, indicating a need for additional support for individuals at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trajectories of change and long-term outcomes in a randomised controlled trial of internet-based insomnia treatment to prevent depression. Batterham, PJ., Christensen, H., Mackinnon, AJ., et al.[2020]

References

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

Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. [2022]

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

Long-term benefits of digital cognitive behavioural therapy for insomnia: Follow-up report from a randomized clinical trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Sleep-specific outcomes attributable to digitally delivered cognitive behavioral therapy for insomnia in adults with insomnia and depressive symptoms. [2023]

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

The effect of sleep-wake intraindividual variability in digital cognitive behavioral therapy for insomnia: a mediation analysis of a large-scale RCT. [2021]

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

Digital Cognitive Behavioral Therapy for Insomnia Using a Smartphone Application in China: A Pilot Randomized Clinical Trial. [2023]

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

Comparative Effectiveness of Digital Cognitive Behavioral Therapy vs Medication Therapy Among Patients With Insomnia. [2023]

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

Effects of Brief Cognitive Behavioral Therapy for Insomnia on Improving Depression Among Community-Dwelling Older Adults: A Randomized Controlled Comparative Study. [2022]

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

Change in Dysfunctional Sleep-Related Beliefs is Associated with Changes in Sleep and Other Health Outcomes Among Older Veterans With Insomnia: Findings From a Randomized Controlled Trial. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Trajectories of change and long-term outcomes in a randomised controlled trial of internet-based insomnia treatment to prevent depression. [2020]