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NCT01641263 · ClinicalTrials.gov registry record · NA
Promoting Sleep and Healthy Aging Research Study (PRO-SHARE)
A NA study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- NA
- Development phase
- 308
- Enrollment target
NCT01641263 is a NA study that has completed, run by University of California, Los Angeles. The registered enrollment target is 308 participants.
The verdict
NCT01641263, a NA study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- NA
- Development phase
- 308 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the ability of a behavioral intervention, cognitive behavioral therapy for sleep quality (CBT-SQ) to reduce sleep complaints, depression recurrence, and cellular and genomic markers of inflammation in older adults with sleep complaints who have a prior history of depression. The investigators aim to: 1) evaluate the effects of CBT-SQ vs. Sleep Seminar (SS) on objective (actigraphy) and subjective (sleep diary; questionnaire) measures of sleep symptoms over a two-year follow-up; 2) determine the effects of CBT-SQ vs. SS on recurrence of depressive symptoms and depression episode(s) over a two-year follow-up. The investigators will also secondarily examine the effects of CBT-SQ vs. SS on cellular and genomic markers of inflammation over a two-year follow-up, and explore whether markers of inflammation and cytokine genes can explain variability in the risk of depression recurrence in those older adults receiving CBT-SQ vs. SS. The present study is highly significant by being the first study, to the investigators knowledge, to focus on the prevention of depression in community dwelling older adults who have a history of depression, and by targeting sleep disturbance, a modifiable risk factor to prevent depression recurrence.
Interventions
- BEHAVIORAL Sleep Education Therapy
- BEHAVIORAL Cognitve Behavioral Therapy for Insomnia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 308 participants |
| Start Date | 2012-07 |
| Est. Completion | 2018-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01641263
The ClinicalTrials.gov registry entry for NCT01641263 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 308 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sleep Education Therapy is the first listed.
NCT01641263 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01641263 about?
NCT01641263 is a clinical study titled "Promoting Sleep and Healthy Aging Research Study (PRO-SHARE)". The objective of this study is to evaluate the ability of a behavioral intervention, cognitive behavioral therapy for sleep quality (CBT-SQ) to reduce sleep complaints, depression recurrence, and cellular and genomic markers of inflammation in older adults with sleep complaints who have a prior hist...
What is the current status of trial NCT01641263?
This trial is currently completed. It is a NA study. The enrollment target is 308 participants. The study started on 2012-07. Estimated completion is 2018-07.
What interventions are being tested in trial NCT01641263?
The interventions under investigation include: Sleep Education Therapy (BEHAVIORAL), Cognitve Behavioral Therapy for Insomnia (BEHAVIORAL).
Who is sponsoring clinical trial NCT01641263?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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