Rest to Overcome Loss and Reduce Risk (RESTore Plus)

Developing a Targeted Intervention for Sleep Disturbance in Spousal Bereavement

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).

Study Overview

• Status: Completed
• Conditions: Quality of Life; Inflammation; Sleep Disturbance; Bereavement; Spouses
• Intervention / Treatment: Behavioral: Targeted Cognitive Behavior Therapy for Insomnia; Other: Information-Only Control

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 years or older
• Has experienced the loss of a spouse/long-term cohabitating partner (i.e., partner who lived with participant for at least 1 year before passing) within the past 3 months
• Scores 5 or above on the Pittsburgh Sleep Quality Inventory (PSQI; administered by research staff during phone screening call)
• Must have access to an internet-enabled device (e.g., smartphone, computer, tablet) to take part in the online intervention

Exclusion Criteria:

• Under age 18
• Non-English speakers
• Those with a previously diagnosed sleep disorder (e.g., restless leg syndrome; note: individuals with obstructive sleep apnea (OSA) will be eligible as long as they use a continuous positive airway pressure (CPAP) machine at least 5 days a week for at least 5 hours per day)
• Those who have been taking prescribed sleep medication(s) for 6 months or more
• Those with autoimmune or inflammatory diseases (such as: acute or chronic immune system medical conditions, medications or other conditions that impact immune function (e.g., chronic fatigue syndrome [CFS], lupus, rheumatoid arthritis, Sjogren's disease, systemic lupus erythematosus [SLE], Hepatitis C, or any other immunosuppressive treatment requiring conditions, per investigator discretion).
• Those who regularly use illegal substances.
• Those who are on medications with major immunological consequences (e.g. steroids)
• Women who are pregnant or nursing
• Those who have been vaccinated in the past two weeks (note: these individuals may simply delay enrollment by two weeks if otherwise eligible)
• Those with significant visual or auditory impairment, medical or psychiatric condition that is unstable, requires immediate treatment or is judged to interfere with study protocol (e.g., substance abuse, psychotic disorder, cognitive disorder, current suicidal ideation)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Targeted Intervention for Sleep and Bereavement (Targeted CBT-I); 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.	Behavioral: Targeted Cognitive Behavior Therapy for Insomnia; This intervention consists of six, 50-min. online individual sessions delivered via video conference. Content was developed by tailoring standard cognitive behavioral therapy for insomnia (CBT-I) to the specific needs of people who recently lost spouses/long-term partners, by using qualitative data gathered in focus groups. The intervention incorporates key concepts of CBT-I (sleep restriction; stimulus control) and positive emotion psychology (everyday mindfulness; gratitude and self-compassion). Individualized sleep plans (including weekly sleep windows) will be created for intervention participants, and each weekly session will involve a discussion about participants' progress in improving sleep disturbance. Support and recommended coping skills for loss and bereavement will also be provided.
Placebo Comparator: Information-Only Control; 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.	Other: Information-Only Control; The control session (approx. 50-min. in length) will be delivered online in a one-to-one format (participant and facilitator) via videoconference. Educational brochures based on recommendations provided by the American Academy of Sleep Medicine focused on sleep and health and sleep hygiene education will be used. No specific or individualized recommendations will be given to control participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of recruitment	Feasibility of recruitment will be demonstrated by an enrollment benchmark of 2 participants per month.	Approximately 18 months
Feasibility of recruitment	Feasibility of recruitment will also be measured by the proportion of eligible participants who are enrolled (consented) and randomized.	Approx. 18 months
Adherence to the intervention	Adherence to the intervention will be measured by the number of sessions attended by participants.	Approx. 6 months
Treatment-specific retention rates	Treatment-specific retention will be measured by the percentage of participants who complete the post-treatment assessment in each arm.	Approx. 6 months
Acceptability	The acceptability of the intervention will be demonstrated by ≥ 85% completion of the study protocol across the sample.	Approx. 6 months
Attrition	Attrition will be measured at each follow-up visit (post intervention and 6-month follow-up) and will be defined by the percentage of randomized participants who did not attend the follow-up visit. Causes of attrition will be measured by analyzing reasons for participant drop-out as documented over the course of the study.	Approx. 6 months
Treatment-specific acceptability	Treatment-specific acceptability will be measured by preference ratings gathered during the post-treatment debriefing session for each arm.	Approx. 6 months
Preliminary change in sleep disturbance	Using the previously validated Pittsburgh Sleep Quality Index (PSQI), change in sleep disturbance will be assessed from baseline to 1. post-intervention (6-8 weeks later), and a 2. six-month follow-up. Global scores on the PSQI range from 0 to 21, with a higher score indicating more severe sleep disturbance.	Approx. 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preliminary change in inflammation	Changes in inflammation will be measured via inflammatory marker values in participant blood samples (interleukin 6 [IL-6], interleukin 8 [IL-8], interleukin 10 [IL-10], tumor necrosis factor alpha [TNF-α]) and will be assessed from baseline to post-intervention (6-8 weeks later).	Approx. 8 weeks
Preliminary change in quality of life	Using the previously validated Research and Development (RAND) Corporation 36-Item Short Form Health Survey (SF-36), change in self-reported quality of life (General Health Subscale) will be assessed from baseline to 1. post-intervention (6-8 weeks later), and a 2. six-month follow-up. The General Health Subscale of the SF-36 ranges from 0 to 100 with higher scores indicating more favorable quality of life.	Approx. 6 months

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): August 31, 2025
• Study Completion (Actual): August 31, 2025

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; inflammation; sleep disturbance; bereavement; spouses
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Pathologic Processes; Sleep Wake Disorders; Pathological Conditions, Signs and Symptoms; Parasomnias; Inflammation
• Other Study ID Numbers: SP0058437; STU00212514 (Other Identifier: Northwestern University Institutional Review Board); 5K01HL149987-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the primary results of the trial after deidentification will be shared.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following publication of the primary results.
• IPD Sharing Access Criteria: Data will be available for individual participant data meta-analysis. Proposals may be submitted up to 36 months following publication of the primary results and should be directed to diana.chirinos@northwestern.edu.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No