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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
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.
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.
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Feasibility of recruitment
Feasibility of recruitment will be demonstrated by an enrollment benchmark of 2 participants per month.
Time frame: 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.
Time frame: Approx. 18 months
Adherence to the intervention
Adherence to the intervention will be measured by the number of sessions attended by participants.
Time frame: 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.
Time frame: Approx. 6 months
Acceptability
The acceptability of the intervention will be demonstrated by ≥ 85% completion of the study protocol across the sample.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Approx. 6 months
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).
Time frame: 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.
Time frame: Approx. 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.