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Cognitive Behavioral Therapy for Sleep Disorders Due to Loss (RESTore Plus Trial)
N/A
Recruiting
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
Awards & highlights
RESTore Plus Trial Summary
This trial will study how a targeted sleep intervention for people who have lost a spouse/partner affects sleep and inflammation. Participants will attend 2 visits & complete 6 online sessions with a trained facilitator.
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.Check my eligibility
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.See study design
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.
RESTore Plus Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approx. 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approx. 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability
Adherence to the intervention
Attrition
+4 moreSecondary outcome measures
Preliminary change in inflammation
Preliminary change in quality of life
RESTore Plus 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.
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.
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,601 Previous Clinical Trials
915,619 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,406 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,848 Previous Clinical Trials
47,818,222 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I have a sleep disorder but use a CPAP machine if it's OSA.I have been on sleep medication for over 6 months.I am not pregnant or nursing.I am 18 years old or older.I am taking medication that significantly affects my immune system.
Research Study Groups:
This trial has the following groups:- Group 1: Targeted Intervention for Sleep and Bereavement (Targeted CBT-I)
- Group 2: Information-Only Control
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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