Promoting Sleep and Healthy Aging Research Study (PRO-SHARE)



Status:Completed
Conditions:Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:60 - Any
Updated:9/8/2018
Start Date:July 2012
End Date:July 2018

Use our guide to learn which trials are right for you!

Aging: Sleep and Inflammatory Mechanism in Depression Prevention

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.


Inclusion Criteria:

- Older adults >= 60 year of age

- Evidence of self-reported sleep disturbance as indexed by PSQI scores >5.

Exclusion Criteria:

Psychiatric Disorders.

1. current major depressive disorder or other DSM-IV psychiatric disorder (e.g. substance
dependence) with the exception of a anxiety disorder;

2. presence of psychotic symptoms

3. acute suicidal or violent behavior or history of suicide attempt within the last year;

Sleep Disorders.

4. current or lifetime history of sleep disorder (sleep apnea, nocturnal myoclonus,
phase-shift disorder) as identified by SCID-IV and the Duke Structured Interview for
Sleep Disorders (DSISD); persons with co-morbid insomnia will be included

Medical conditions.

5. severe or acute medical illness (e.g., major surgery, metastatic cancer, stroke, or
myocardial infarction) six months prior to study entry presence of co-morbid medical
conditions; 5) neurological diseases (e.g., Parkinson's diseases, multiple sclerosis;
neurodegenerative dementia,);

6. severe pain disorders requiring daily pain management;

7. presence of co-morbid inflammatory disorders such as rheumatoid arthritis and other
autoimmune disorders that would confound the assessment of sleep as well as
inflammatory markers;

8. presence of uncontrolled medical condition that is deemed by the investigators to
interfere with the proposed study procedures, or put the study participant at undue
risk (e.g., an active heart failure categorized as Class III or greater according to
New York Heart Association criteria; symptomatic cardiac arrhythmias; symptomatic,
hemodynamically significant mitral or aortic valvular disease);

9. presence of chronic infections, which may elevate proinflammatory cytokines. While we
will not exclude this individuals only behavioral outcomes will be measured on these
subjects. No analysis of blood will be performed. (If a history of an acute infectious
illness is identified within two weeks of a scheduled blood sampling, the session will
be rescheduled to occur outside this two week period);

Medication and substance use.

10. use of hormone containing medications including steroids;

11. immune modifying drugs that target specific immune responses agents such as TNF
antagonists;

12. daily use of analgesics such as opioids. We will include those taking psychotropic
medications (except for anti-psychotic medications or who have have been treated with
a depot-neuroleptic within 6 months prior to study entry) In regards to psychotropic
medication use, we will quantify past, current, and ongoing use of psychotropic
medications (e.g., selective serotonin reuptake inhibitors, other antidepressants,
anxiolytics, hypnotics, sedatives) and assess the effects of these medications on
primary outcomes during the intervention, and follow-up period.
We found this trial at
1
site
Los Angeles, California 91744
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials