Sleep DisturbanceRESTore PlusNCT05803499
Rest to Overcome Loss and Reduce Risk
A study testing Targeted Cognitive Behavior Therapy for Insomnia in people with Sleep Disturbance and Inflammation, run by Northwestern University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance, Inflammation, Quality of Life
- What is being tested?
- Targeted Cognitive Behavior Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: Developing a Targeted Intervention for Sleep Disturbance in Spousal Bereavement
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).
- Conditions
- Sleep Disturbance, Inflammation, Quality of Life, Bereavement, Spouses
- Being tested
- Targeted Cognitive Behavior Therapy for Insomnia, Information-Only Control
- Keywords
- sleep disturbance, inflammation, quality of life, bereavement, spouses
- Medical subject headings
- Parasomnias, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Cognitive Behavior Therapy for InsomniaBehavioural
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.
Information-Only ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Targeted Intervention for Sleep and Bereavement (Targeted CBT-I) | Experimental | 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. Receives: Behavioral: Targeted Cognitive Behavior Therapy for Insomnia |
| Information-Only Control | Placebo comparator | 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. Receives: Other: Information-Only Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
Feasibility of recruitment will be demonstrated by an enrollment benchmark of 2 participants per month.
Measured: 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.
Measured: Approx. 18 months
Adherence to the intervention
Adherence to the intervention will be measured by the number of sessions attended by participants.
Measured: 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.
Measured: Approx. 6 months
Acceptability
The acceptability of the intervention will be demonstrated by ≥ 85% completion of the study protocol across the sample.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approx. 6 months
Secondary outcomes (2)
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).
Measured: 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.
Measured: Approx. 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 Mar 2023
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Diana Chirinos-Downie, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803499
- Sponsor's protocol ID
- SP0058437
- Other IDs
- STU00212514, 5K01HL149987-02
- Acronym
- RESTore Plus
- Status last verified
- Jan 2026
- First submitted
- 21 Feb 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the primary results of the trial after deidentification will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Targeted Intervention for Sleep Disturbance in Spousal Bereavement
- ClinicalTrials.gov ID
- NCT05803499
- Acronym / sponsor ID
- RESTore Plus / SP0058437
- Conditions
- Sleep Disturbance, Inflammation, Quality of Life, Bereavement, Spouses
- Keywords
- sleep disturbance, inflammation, quality of life, bereavement, spouses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Targeted Intervention for Sleep and Bereavement (Targeted CBT-I) | Experimental | Behavioral: Targeted Cognitive Behavior Therapy for InsomniaThis 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. |
| Information-Only Control | Placebo comparator | Other: Information-Only ControlThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted Cognitive Behavior Therapy for InsomniaThis 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. | Behavioural | Targeted Intervention for Sleep and Bereavement (Targeted CBT-I) |
| Information-Only ControlThe 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. | Other | Information-Only Control |
Primary outcome
Feasibility of recruitment
Time frame: Approximately 18 months
Feasibility of recruitment will be demonstrated by an enrollment benchmark of 2 participants per month.
Feasibility of recruitment
Time frame: Approx. 18 months
Feasibility of recruitment will also be measured by the proportion of eligible participants who are enrolled (consented) and randomized.
Adherence to the intervention
Time frame: Approx. 6 months
Adherence to the intervention will be measured by the number of sessions attended by participants.
Treatment-specific retention rates
Time frame: Approx. 6 months
Treatment-specific retention will be measured by the percentage of participants who complete the post-treatment assessment in each arm.
Acceptability
Time frame: Approx. 6 months
The acceptability of the intervention will be demonstrated by ≥ 85% completion of the study protocol across the sample.
Attrition
Time frame: Approx. 6 months
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
Time frame: Approx. 6 months
Treatment-specific acceptability will be measured by preference ratings gathered during the post-treatment debriefing session for each arm.
Preliminary change in sleep disturbance
Time frame: Approx. 6 months
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.
2 secondary outcomes
Preliminary change in inflammation
Time frame: Approx. 8 weeks
Preliminary change in quality of life
Time frame: Approx. 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the primary results of the trial after deidentification will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Cognitive Behavior Therapy for Insomnia in people with Sleep Disturbance and Inflammation, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment (time frame: Approximately 18 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.