Rest to Overcome Loss and Reduce Risk (RESTore Plus)

Northwestern University

Status: Active, not recruiting

Conditions: Inflammation; Quality of Life; Bereavement; Spouses; Sleep Disturbance

Treatments: Other: Information-Only Control; Behavioral: Targeted Cognitive Behavior Therapy for Insomnia

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05803499

5K01HL149987-02 (U.S. NIH Grant/Contract)

SP0058437

STU00212514 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

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

Experimental group

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.

Treatment:

Behavioral: Targeted Cognitive Behavior Therapy for Insomnia

Information-Only Control

Placebo Comparator group

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.

Treatment:

Other: Information-Only Control