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NCT05803499 · ClinicalTrials.gov registry record · NA
Rest to Overcome Loss and Reduce Risk
A NA study, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT05803499 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 40 participants.
The verdict
NCT05803499, a NA study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
The purpose of this study is to develop and optimize a targeted behavioral intervention for sleep disturbance among individuals who have recently lost a spouse/long-term cohabitating partner. In the first phase of this study, patient focus groups were conducted to gather information about the unique sleep challenges experienced by spousally bereaved individuals and the kinds of support they would like to receive from a program based on Cognitive Behavior Therapy for Insomnia (CBT-I). In the second phase of the study, a two-arm randomized controlled trial will be conducted to compare changes in sleep and inflammation among participants in the targeted CBT-I intervention to those in an information-only control. Participants will be asked to attend two in-person visits (at baseline and, approx. 8 weeks later, at post-treatment) to provide a blood sample and have vital signs and basic anthropometric measurements (height, weight, waist circumference) taken. After their baseline visit, participants will be randomized into either the targeted CBT-I intervention or the information-only control. The targeted CBT-I intervention will entail 6 online sessions (approx. 50 mins. each) delivered via videoconference by a trained facilitator, once per week over the course of approx. 6 weeks. The information-only control will entail 1 online session (approx. 50 mins.) delivered via videoconference by a trained facilitator. Sleep data (collected via both actigraphy watches and patient self-report sleep diaries) and data on mood, grief, and sleep habits will be collected from participants at three timepoints (baseline, post-treatment, and then again at a 6-month follow-up).
Interventions
- BEHAVIORAL Targeted Cognitive Behavior Therapy for Insomnia
- OTHER Information-Only Control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-03-01 |
| Est. Completion | 2025-08-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05803499
The ClinicalTrials.gov registry entry for NCT05803499 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Targeted Cognitive Behavior Therapy for Insomnia is the first listed.
NCT05803499 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05803499 about?
NCT05803499 is a clinical study titled "Rest to Overcome Loss and Reduce Risk". The purpose of this study is to develop and optimize a targeted behavioral intervention for sleep disturbance among individuals who have recently lost a spouse/long-term cohabitating partner. In the first phase of this study, patient focus groups were conducted to gather information about the unique...
What is the current status of trial NCT05803499?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2023-03-01. Estimated completion is 2025-08-31.
What interventions are being tested in trial NCT05803499?
The interventions under investigation include: Targeted Cognitive Behavior Therapy for Insomnia (BEHAVIORAL), Information-Only Control (OTHER).
Who is sponsoring clinical trial NCT05803499?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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