What is the mechanism of action of this treatment?

Common treatments for improving Quality of Life (QoL) often involve behavioral interventions like Cognitive Behavioral Therapy for Insomnia (CBT-I). These treatments work by modifying thought patterns and behaviors that disrupt sleep, using techniques such as sleep hygiene education, cognitive restructuring, and relaxation exercises. By improving sleep quality, these interventions can reduce insomnia-related symptoms, which in turn can alleviate mood disturbances, fatigue, and impaired daily functioning. This is crucial for QoL patients as better sleep can lead to enhanced physical and mental health, thereby significantly improving their overall quality of life.

What side effects are associated with this type of intervention?

Cognitive-behavioral therapy for insomnia (CBT-I) and similar behavioral interventions generally have minimal side effects compared to pharmacological treatments. Commonly reported side effects include temporary increases in anxiety or stress as patients confront and modify maladaptive sleep behaviors and thoughts. Some individuals may experience initial sleep disturbances as they adjust to new sleep patterns. Overall, these side effects are typically mild and transient, with the benefits of improved sleep quality and reduced insomnia outweighing the temporary discomfort.

What prior FDA approvals exist?

The FDA has approved several treatments aimed at improving quality of life by addressing sleep disturbances and insomnia. Cognitive Behavioral Therapy for Insomnia (CBT-I) is a non-pharmacological intervention that has shown efficacy in improving sleep patterns and reducing insomnia through cognitive and behavioral techniques. While CBT-I itself is not a drug, it is a widely recognized and recommended treatment for insomnia. Additionally, the FDA has approved medications such as melatonin and certain antidepressants (e.g., trazodone) that can aid in sleep improvement and are sometimes used in conjunction with behavioral therapies. These treatments collectively aim to enhance sleep quality, thereby improving overall quality of life.

What other types of research exist?

Promising novel alternatives to Targeted Cognitive Behavior Therapy for Insomnia (CBT-I) for improving quality of life in patients include: 1) Light Therapy, which has shown effectiveness in improving sleep patterns and reducing fatigue, particularly in cancer patients and those with circadian rhythm disorders. 2) Hypnosis, which has demonstrated benefits in reducing hot flashes and improving sleep quality, although further standardization and research are needed. 3) Mindfulness-Based Cognitive Therapy (MBCT), which has been effective in managing treatment-resistant depression and may offer benefits for sleep disturbances through stress reduction and cognitive restructuring.

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Cognitive Behavioral Therapy for Sleep Disorders Due to Loss (RESTore Plus Trial)

N/A

Waitlist Available

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approx. 18 months

Summary

This trial aims to help people who have recently lost a spouse or partner improve their sleep through a special type of therapy called Cognitive Behavior Therapy for Insomnia (CBT-I). Participants will have several online sessions with a trained therapist to learn better sleep habits. The study will compare this therapy to another group that only receives one informational session.

Who is the study for?

This trial is for adults who've lost a spouse or long-term partner within the last 3 months and are having sleep problems. They need internet access for online sessions and must score above a threshold on a sleep quality survey. Excluded are non-English speakers, pregnant/nursing women, those with certain medical conditions, long-term users of prescribed sleep meds, diagnosed with specific sleep disorders (except controlled OSA), drug users, and people on immunological medications.

What is being tested?

The study tests whether targeted Cognitive Behavior Therapy for Insomnia (CBT-I) can improve sleep among recently bereaved spouses compared to just getting information. Participants will either join six weekly online CBT-I sessions or attend one informational session and have their sleep monitored through watches and diaries at different stages.

What are the potential side effects?

Since this is a behavioral therapy trial focusing on insomnia after spousal loss rather than medication or invasive procedures, significant side effects aren't anticipated. However, discussing emotional topics during therapy could potentially cause temporary distress.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approx. 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approx. 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approx. 18 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Acceptability

Adherence to the intervention

Attrition

+4 more

Secondary study objectives

Preliminary change in inflammation

Preliminary change in quality of life

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Targeted Intervention for Sleep and Bereavement (Targeted CBT-I)Experimental Treatment1 Intervention

This intervention consists of 6, 50-60-minute online individual sessions delivered via video conference. Content will include a CBT-I based program adapted to the specific needs of spousally bereaved individuals.

Group II: Information-Only ControlPlacebo Group1 Intervention

The information-only control consists of 1, 50-60-minute online individual session delivered via video conference. Content will provide basic psychoeducation about sleep and aging.

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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

Common treatments for improving Quality of Life (QoL) often involve behavioral interventions like Cognitive Behavioral Therapy for Insomnia (CBT-I). These treatments work by modifying thought patterns and behaviors that disrupt sleep, using techniques such as sleep hygiene education, cognitive restructuring, and relaxation exercises. By improving sleep quality, these interventions can reduce insomnia-related symptoms, which in turn can alleviate mood disturbances, fatigue, and impaired daily functioning. This is crucial for QoL patients as better sleep can lead to enhanced physical and mental health, thereby significantly improving their overall quality of life.