The Association Between CBT-I Dose and Innate Immunity in Insomnia and Fatigue in Prostate Cancer Patients
NCT ID: NCT06604247
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2020-09-30
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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4-session
Participants randomized to this condition received 4 weekly CBT-I sessions.
Cognitive Behavioral therapy for insomnia (CBT-I)
Cognitive Behavioral Therapy for Insomnia includes evaluation and orientation; data acquisition and delivery of sleep restriction therapy \& stimulus control instructions; review of sleep hygiene; cognitive therapy \[decatastrophization\]; managing nonadherence and relapse prevention), and, finally, the final sessions will be largely focused on time-in-bed titration.
8-session
Participants randomized to this condition received 8 weekly CBT-I sessions.
Cognitive Behavioral therapy for insomnia (CBT-I)
Cognitive Behavioral Therapy for Insomnia includes evaluation and orientation; data acquisition and delivery of sleep restriction therapy \& stimulus control instructions; review of sleep hygiene; cognitive therapy \[decatastrophization\]; managing nonadherence and relapse prevention), and, finally, the final sessions will be largely focused on time-in-bed titration.
10-session
Participants randomized to this condition received 10 weekly CBT-I sessions.
Cognitive Behavioral therapy for insomnia (CBT-I)
Cognitive Behavioral Therapy for Insomnia includes evaluation and orientation; data acquisition and delivery of sleep restriction therapy \& stimulus control instructions; review of sleep hygiene; cognitive therapy \[decatastrophization\]; managing nonadherence and relapse prevention), and, finally, the final sessions will be largely focused on time-in-bed titration.
12-session
Participants randomized to this condition received 12 weekly CBT-I sessions.
Cognitive Behavioral therapy for insomnia (CBT-I)
Cognitive Behavioral Therapy for Insomnia includes evaluation and orientation; data acquisition and delivery of sleep restriction therapy \& stimulus control instructions; review of sleep hygiene; cognitive therapy \[decatastrophization\]; managing nonadherence and relapse prevention), and, finally, the final sessions will be largely focused on time-in-bed titration.
Interventions
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Cognitive Behavioral therapy for insomnia (CBT-I)
Cognitive Behavioral Therapy for Insomnia includes evaluation and orientation; data acquisition and delivery of sleep restriction therapy \& stimulus control instructions; review of sleep hygiene; cognitive therapy \[decatastrophization\]; managing nonadherence and relapse prevention), and, finally, the final sessions will be largely focused on time-in-bed titration.
Eligibility Criteria
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Inclusion Criteria
* Received radiation treatment
* Willing and able to provide informed consent
* Endorse problem with both insomnia and cancer-related fatigue, as measured by the insomnia severity index, Multidimensional Fatigue Symptom Inventory (short form) and the Brief Fatigue Inventory
Exclusion Criteria
* History of narcolepsy
* Night shift work
* Distant metastatic disease at presentation
* Active drug/alcohol dependence
40 Years
85 Years
ALL
No
Sponsors
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Abramson Cancer Center at Penn Medicine
OTHER
Responsible Party
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Locations
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University Of Pennsylvania, Behavioral Sleep Medicine Program
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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834620
Identifier Type: -
Identifier Source: org_study_id
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