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

Completed · Not applicable

Conditions studied: Depression

In brief

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.

Key facts

Study ID

NCT01641263

Run by

University of California, Los Angeles

People needed

308

Starts

2012-07-01

Expected to finish

2018-07-01

Last updated by the study team

2020-09-30

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Older adults >= 60 year of age
• Evidence of self-reported sleep disturbance as indexed by PSQI scores >5.

You may not qualify if…

• Psychiatric Disorders.
• current major depressive disorder or other DSM-IV psychiatric disorder (e.g. substance dependence) with the exception of a anxiety disorder;
• presence of psychotic symptoms
• acute suicidal or violent behavior or history of suicide attempt within the last year;
• Sleep Disorders.
• 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.
• 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,);
• severe pain disorders requiring daily pain management;
• 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;
• 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);
• 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.
• use of hormone containing medications including steroids;
• immune modifying drugs that target specific immune responses agents such as TNF antagonists;
• 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.

Where it is running

• UCLA Cousins Center for Psychoneuroimmunology — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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