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Rest to Overcome Loss and Reduce Risk (RESTore Plus)

Primary Purpose

Sleep Disturbance, Inflammation, Quality of Life

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Targeted Cognitive Behavior Therapy for Insomnia
Information-Only Control
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disturbance focused on measuring sleep disturbance, inflammation, quality of life, bereavement, spouses

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Northwestern University Feinberg School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Targeted Intervention for Sleep and Bereavement (Targeted CBT-I)

Information-Only Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Feasibility of recruitment
Feasibility of recruitment will be demonstrated by an enrollment benchmark of 2 participants per month.
Feasibility of recruitment
Feasibility of recruitment will also be measured by the proportion of eligible participants who are enrolled (consented) and randomized.
Adherence to the intervention
Adherence to the intervention will be measured by the number of sessions attended by participants.
Treatment-specific retention rates
Treatment-specific retention will be measured by the percentage of participants who complete the post-treatment assessment in each arm.
Acceptability
The acceptability of the intervention will be demonstrated by ≥ 85% completion of the study protocol across the sample.
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.
Treatment-specific acceptability
Treatment-specific acceptability will be measured by preference ratings gathered during the post-treatment debriefing session for each arm.
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.

Secondary Outcome Measures

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).
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.

Full Information

First Posted
February 21, 2023
Last Updated
March 27, 2023
Sponsor
Northwestern University
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05803499
Brief Title
Rest to Overcome Loss and Reduce Risk
Acronym
RESTore Plus
Official Title
Developing a Targeted Intervention for Sleep Disturbance in Spousal Bereavement
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance, Inflammation, Quality of Life, Bereavement, Spouses
Keywords
sleep disturbance, inflammation, quality of life, bereavement, spouses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This pilot will test the targeted intervention for feasibility, acceptability, and preliminary effects. Participants will be randomized to either 1) the targeted intervention for bereavement and sleep disturbance based on Cognitive Behavior Therapy for Insomnia (CBT-I), and 2) an information-only control. Participants will complete self-report measures and an in-person visit at baseline and post-treatment, and a 6-month follow-up (psychosocial measures only).
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Participants will not be informed which arm they have been randomized into. Research assistants will also be blinded to randomization. Only the control and intervention session facilitators and Principal Investigator will be aware of participants' study arm.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Targeted Intervention for Sleep and Bereavement (Targeted CBT-I)
Arm Type
Experimental
Arm Description
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.
Arm Title
Information-Only Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Targeted Cognitive Behavior Therapy for Insomnia
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Information-Only Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of recruitment
Description
Feasibility of recruitment will be demonstrated by an enrollment benchmark of 2 participants per month.
Time Frame
Approximately 18 months
Title
Feasibility of recruitment
Description
Feasibility of recruitment will also be measured by the proportion of eligible participants who are enrolled (consented) and randomized.
Time Frame
Approx. 18 months
Title
Adherence to the intervention
Description
Adherence to the intervention will be measured by the number of sessions attended by participants.
Time Frame
Approx. 6 months
Title
Treatment-specific retention rates
Description
Treatment-specific retention will be measured by the percentage of participants who complete the post-treatment assessment in each arm.
Time Frame
Approx. 6 months
Title
Acceptability
Description
The acceptability of the intervention will be demonstrated by ≥ 85% completion of the study protocol across the sample.
Time Frame
Approx. 6 months
Title
Attrition
Description
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.
Time Frame
Approx. 6 months
Title
Treatment-specific acceptability
Description
Treatment-specific acceptability will be measured by preference ratings gathered during the post-treatment debriefing session for each arm.
Time Frame
Approx. 6 months
Title
Preliminary change in sleep disturbance
Description
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.
Time Frame
Approx. 6 months
Secondary Outcome Measure Information:
Title
Preliminary change in inflammation
Description
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).
Time Frame
Approx. 8 weeks
Title
Preliminary change in quality of life
Description
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.
Time Frame
Approx. 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diana A. Chirinos, PhD
Phone
312-503-6621
Email
diana.chirinos@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica L. Thomas, MA
Phone
312-503-3225
Email
jessica.thomas@northwestern.edu
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana A. Chirinos, PhD
Phone
312-503-6621
Email
diana.chirinos@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Jessica L. Thomas, MA
Phone
312-503-3225
Email
jessica.thomas@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Diana A. Chirinos, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Rest to Overcome Loss and Reduce Risk

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