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Cognitive Behavioral Therapy for Sleep Disorders Due to Loss (RESTore Plus Trial)

N/A

Recruiting

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approx. 18 months

Awards & highlights

RESTore Plus Trial Summary

This trial will study how a targeted sleep intervention for people who have lost a spouse/partner affects sleep and inflammation. Participants will attend 2 visits & complete 6 online sessions with a trained facilitator.

Who is the study for?

This trial is for adults who've lost a spouse or long-term partner within the last 3 months and are having sleep problems. They need internet access for online sessions and must score above a threshold on a sleep quality survey. Excluded are non-English speakers, pregnant/nursing women, those with certain medical conditions, long-term users of prescribed sleep meds, diagnosed with specific sleep disorders (except controlled OSA), drug users, and people on immunological medications.Check my eligibility

What is being tested?

The study tests whether targeted Cognitive Behavior Therapy for Insomnia (CBT-I) can improve sleep among recently bereaved spouses compared to just getting information. Participants will either join six weekly online CBT-I sessions or attend one informational session and have their sleep monitored through watches and diaries at different stages.See study design

What are the potential side effects?

Since this is a behavioral therapy trial focusing on insomnia after spousal loss rather than medication or invasive procedures, significant side effects aren't anticipated. However, discussing emotional topics during therapy could potentially cause temporary distress.

RESTore Plus Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

RESTore Plus Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approx. 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approx. 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approx. 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability

Adherence to the intervention

Attrition

+4 more

Secondary outcome measures

Preliminary change in inflammation

Preliminary change in quality of life

RESTore Plus Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Targeted Intervention for Sleep and Bereavement (Targeted CBT-I)Experimental Treatment1 Intervention

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.

Group II: Information-Only ControlPlacebo Group1 Intervention

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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,585 Previous Clinical Trials

917,191 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,539 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,834 Previous Clinical Trials

47,310,595 Total Patients Enrolled

Media Library

Targeted Cognitive Behavior Therapy for Insomnia Clinical Trial Eligibility Overview. Trial Name: NCT05803499 — N/A

Quality of Life Research Study Groups: Targeted Intervention for Sleep and Bereavement (Targeted CBT-I), Information-Only Control

Quality of Life Clinical Trial 2023: Targeted Cognitive Behavior Therapy for Insomnia Highlights & Side Effects. Trial Name: NCT05803499 — N/A

Targeted Cognitive Behavior Therapy for Insomnia 2023 Treatment Timeline for Medical Study. Trial Name: NCT05803499 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are enrolled in this investigation?

"Affirmative. Evidenced by the information available on clinicaltrials.gov, this research is actively recruiting subjects for participation in their study; it was first posted on March 1st of 2023 and most recently updated on March 27th of the same year. The investigation aims to acquire 40 persons from a single site."

Answered by AI

Does this investigation accept participants of over two decades old?

"This trial is seeking individuals who are younger than 80 years old and have surpassed the age of majority."

Answered by AI

Is it possible for me to join this medical research project?

"In order to qualify for this research study, applicants must be afflicted with inflammation and aged between 18 and 80. At present, the trial is expecting a cohort of 40 individuals."

Answered by AI

Is enrollment for this experiment still accessible to participants?

"Affirmative. According to clinicaltrials.gov, this research protocol is currently enrolling individuals for participation. The trial was initiated on March 1st 2023 and the last update occurred on March 27th of the same year. 40 subjects are needed from one single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Rest to Overcome Loss and Reduce Risk

Diana Chirinos-Downie 2023. "Rest to Overcome Loss and Reduce Risk". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05803499.

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