Clinical trial NCT05803499: Rest to Overcome Loss and Reduce Risk
Official title: Developing a Targeted Intervention for Sleep Disturbance in Spousal Bereavement
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sleep Disturbance
Inflammation
Quality of Life
Bereavement
Spouses
Keywords: sleep disturbance
inflammation
quality of life
bereavement
spouses
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-04-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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).


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)

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: Approximately 18 months
measure: Feasibility of recruitment
timeFrame: Approx. 18 months
measure: Adherence to the intervention
timeFrame: Approx. 6 months
measure: Treatment-specific retention rates
timeFrame: Approx. 6 months
measure: Acceptability
timeFrame: Approx. 6 months
measure: Attrition
timeFrame: Approx. 6 months
measure: Treatment-specific acceptability
timeFrame: Approx. 6 months
measure: Preliminary change in sleep disturbance
timeFrame: Approx. 6 months
Secondary outcomes:
measure: Preliminary change in inflammation
timeFrame: Approx. 8 weeks
measure: Preliminary change in quality of life
timeFrame: Approx. 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
References: