What side effects are associated with this type of intervention?

Cognitive Behavioral Therapy for Insomnia (CBT-I) and its digital variant (dCBT-I) are generally well-tolerated with minimal side effects. The most common side effects include temporary increases in anxiety or stress as patients confront and change their sleep habits. Some individuals may experience initial difficulty in adhering to the new sleep schedule or discomfort from the behavioral changes required. In contrast, pharmacotherapy for insomnia, such as benzodiazepines or sedative-hypnotics, can have more significant side effects, including daytime drowsiness, dependency, and cognitive impairment. Melatonin, often used as a first-line treatment, is generally safe but can cause dizziness, headaches, or daytime sleepiness in some cases.

What prior FDA approvals exist?

The FDA has approved several treatments for sleep disorders, including pharmacological options like melatonin, which is often used for insomnia and sleep phase disorders, and non-benzodiazepine hypnotics such as zolpidem. Cognitive Behavioral Therapy for Insomnia (CBT-I), including its digital form (dCBT-I), is a non-pharmacological approach that has shown efficacy in improving sleep patterns and reducing symptoms of insomnia. While dCBT-I itself is not an FDA-approved 'drug,' it is a recognized therapeutic intervention that can be delivered digitally to enhance sleep quality and potentially reduce suicidal ideation in patients with insomnia.

What other types of research exist?

Promising novel alternatives to Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) for treating sleep disorders in 2024 include: 1) Internet-delivered insomnia interventions, which have shown improvements in sleep and quality of life, particularly in specific populations like cancer survivors. 2) Light therapy, which has been found feasible and acceptable for reducing fatigue and improving sleep in adolescents and young adults. 3) Systematic light exposure, which is being explored for its potential to treat cancer-related fatigue and improve sleep patterns. 4) Pharmacological advancements such as new insomnia medications relevant to mental health disorders, which are continually being developed and tested for efficacy and safety.

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Behavioral Intervention

Cognitive Behavioral Therapy for Suicidal Thoughts in Older Adults (ANSWERS-OA Trial)

N/A

Recruiting

Led By Michael A Grandner, PhD

Research Sponsored by MICHAEL A GRANDNER

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Current insomnia (Insomnia Severity Index score ≥ 8 during the baseline period)

Individuals 65 and older

Must not have

Diagnosis of bipolar disorder, any psychotic disorder, or other serious mental illness deemed a contraindication for dCBT-I

Suspicion or evidence of untreated sleep apnea, restless legs syndrome, or other untreated sleep disorder requiring treatment by a physician

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year.

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since dCBT-I is a non-pharmacological treatment involving behavioral changes and cognitive exercises through digital means, typical medication side effects are not expected. However, participants may experience frustration or discomfort adjusting to new sleep habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I currently have trouble sleeping.

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I am 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I might have a sleep disorder like sleep apnea or restless legs syndrome that hasn't been treated.

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I haven't taken any psychotropic drugs for 6 weeks and won't start any new ones during the trial.

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I do not have any uncontrolled or unstable chronic conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Aim 1a: Evaluate whether dCBT-I is a feasible intervention for older adults with insomnia and suicidal ideation.

Aim 1b: Evaluate whether dCBT-I is a feasible intervention for older adults with insomnia and suicidal ideation.

Aim 2: Investigate whether dCBT-I is safe for older adults with suicidal ideation.

Secondary study objectives

Aim 3: Explore whether dCBT-I can reduce suicidal ideation in older adults.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: digital Cognitive Behavioral Therapy for InsomniaExperimental Treatment1 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 ControlActive Control1 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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) works by addressing the underlying cognitive and behavioral factors that contribute to insomnia. It typically includes components such as sleep education, stimulus control, sleep restriction, cognitive restructuring, and relaxation techniques. These interventions help patients develop healthier sleep habits, reduce anxiety around sleep, and correct dysfunctional beliefs about sleep. For patients with sleep disorders, these mechanisms are crucial as they not only improve sleep quality and duration but also enhance overall psychological well-being. Improved sleep patterns can lead to better cognitive functioning and reduced symptoms of depression and anxiety, which are often comorbid with insomnia. This is particularly significant as it may also reduce suicidal ideation, providing a comprehensive approach to managing sleep disorders and associated mental health issues.

Insomnia disorder: State of the science and challenges for the future.