Rest to Overcome Loss and Reduce Risk

Quality of Life Clinical Trial

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Official title:

Developing a Targeted Intervention for Sleep Disturbance in Spousal Bereavement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05803499
• Other study ID #: SP0058437
• Secondary ID: STU002125145K01H
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: May 2025

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: Diana A. Chirinos, PhD
• Phone: 312-503-6621
• Email: diana.chirinos[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bereavement
• Dyssomnias
• Inflammation
• Parasomnias
• Quality of Life
• Sleep Disturbance
• Spouses

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of recruitment	Feasibility of recruitment will be demonstrated by an enrollment benchmark of 2 participants per month.	Approximately 18 months
Primary	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
Primary	Adherence to the intervention	Adherence to the intervention will be measured by the number of sessions attended by participants.	Approx. 6 months
Primary	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
Primary	Acceptability	The acceptability of the intervention will be demonstrated by = 85% completion of the study protocol across the sample.	Approx. 6 months
Primary	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
Primary	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
Primary	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	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-a]) and will be assessed from baseline to post-intervention (6-8 weeks later).	Approx. 8 weeks
Secondary	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