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Dyadic Intervention for Controlled
N/A
Waitlist Available
Led By Jennifer L Steel, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline in depressive symptoms at 12 months
Awards & highlights
Study Summary
This trial will test a sleep intervention specifically designed to help cancer patients and their intimate partners get a better night's sleep.
Eligible Conditions
- Controlled
- Intervention
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline in insomnia reduction at 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline in insomnia reduction at 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Insomnia Severity Index
Secondary outcome measures
Pittsburgh Sleep Quality Index (PSQI)
Other outcome measures
Patient-reported Outcomes Measurement Information System (PROMIS-29)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Modified Cognitive Behavioral Therapy Intervention Patient OnlyExperimental Treatment1 Intervention
The patient in the patient only intervention arm will receive 5 sessions of Modified CBTi. The patient and caregiver will complete the assessment at 3- and 6 months follow up
Group II: Modified Cognitive Behavioral Therapy Intervention DyadicExperimental Treatment1 Intervention
The patient and caregiver in the dyadic intervention will have 5 sessions of Modified CBTi. The patient and caregiver will complete the assessment at 3- and 6 months follow up.
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Who is running the clinical trial?
University of PittsburghLead Sponsor
1,719 Previous Clinical Trials
16,342,291 Total Patients Enrolled
Jennifer L Steel, PhDPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
512 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You sleep in the same bed as your caregiver or significant other.You have trouble sleeping (score of 5 or higher on the PSQI).You or your caregiver do not have sleep problems.You have been diagnosed with narcolepsy or restless legs syndrome.You have been diagnosed with cancer.You have sleep apnea and use a CPAP machine.The person who takes care of you or your close partner has sleep problems based on a questionnaire score.
Research Study Groups:
This trial has the following groups:- Group 1: Modified Cognitive Behavioral Therapy Intervention Dyadic
- Group 2: Modified Cognitive Behavioral Therapy Intervention Patient Only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are actively engaging in this clinical research?
"Indeed, the information available on clinicaltrials.gov displays that this research is actively recruiting participants. The trial was created August 16th 2021 and last modified October 12th 2022; 50 patients are needed from a single site."
Answered by AI
Is enrollment currently available for this research study?
"Affirmative, the clinical trial is actively seeking participants. The study was initiated on August 16th 2021 and last updated October 12nd 2022. It requires 50 patients to be recruited from 1 site."
Answered by AI
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