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

NCT01641263 | Completed DMC

• 2 other identifiers: NIA-RO1-AG026364R01AG026364
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Keywords

Depression Prevention; Sleep Disturbances; Inflammatory Markers; Treatments for Sleep Problems

Outcome Measures

Primary Outcomes (1)

• Change in depression from baseline

  Depressive symptom severity and depressive episodes.

  Up to 3 years

Secondary Outcomes (6)

• Change in inflammation from baseline

  Up to 3 years

• Change in Health and Daily Function from baseline

  Up to 3 years

• Change in Mental Health from baseline

  Up to 3 years

• Change in Physical Activity from baseline

  Up to 3 years

• Change in Social Function from baseline

  Up to 3 years

Study Arms (2)

Cognitive Behavioral Therapy

EXPERIMENTAL

For each 2-hour session held once a week for 8 weeks, the CBT treatment manual will outline objectives, patient skills, and treatment activities. Therapists will direct role-playing and other skill-development exercises that will be designed to increase patients' self-efficacy in managing their insomnia. Homework assignments will be planned weekly to ensure practice and skill application.

Behavioral: Cognitve Behavioral Therapy for Insomnia

Sleep Seminar

ACTIVE COMPARATOR

Each 2-hour session, held once a week for 8 weeks, consists of a 60-minute video presentation followed by a 60-minute question-and-answer discussion

Behavioral: Sleep Education Therapy

Interventions

Sleep Education Therapy BEHAVIORAL

Each 2-hour session, held once a week for 8 weeks, consists of a 60-minute video presentation followed by a 60-minute question-and-answer discussion

Also known as: Sleep seminar

Sleep Seminar

Cognitve Behavioral Therapy for Insomnia BEHAVIORAL

For each 2-hour session held once a week for 8 weeks, the CBT treatment manual will outline objectives, patient skills, and treatment activities. Therapists will direct role-playing and other skill-development exercises that will be designed to increase patients' self-efficacy in managing their insomnia. Homework assignments will be planned weekly to ensure practice and skill application.

Also known as: Cognitive Behavioral Therapy

Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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;

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UCLA Cousins Center for Psychoneuroimmunology

Los Angeles, California, 90095, United States

Location

Related Publications (5)

• Cho HJ, Lavretsky H, Olmstead R, Levin M, Oxman MN, Irwin MR. Prior depression history and deterioration of physical health in community-dwelling older adults--a prospective cohort study. Am J Geriatr Psychiatry. 2010 May;18(5):442-51. doi: 10.1097/JGP.0b013e3181ca3a2d.

  PMID: 20220581 BACKGROUND

• Cho HJ, Lavretsky H, Olmstead R, Levin MJ, Oxman MN, Irwin MR. Sleep disturbance and depression recurrence in community-dwelling older adults: a prospective study. Am J Psychiatry. 2008 Dec;165(12):1543-50. doi: 10.1176/appi.ajp.2008.07121882. Epub 2008 Sep 2.

  PMID: 18765482 BACKGROUND

• Meeks TW, Wetherell JL, Irwin MR, Redwine LS, Jeste DV. Complementary and alternative treatments for late-life depression, anxiety, and sleep disturbance: a review of randomized controlled trials. J Clin Psychiatry. 2007 Oct;68(10):1461-71. doi: 10.4088/jcp.v68n1001.

  PMID: 17960959 BACKGROUND

• Bjurstrom MF, Olmstead R, Irwin MR. Insomnia remission and improvement of bodily pain in older adults: a randomized clinical trial. Pain Rep. 2025 Feb 5;10(2):e1243. doi: 10.1097/PR9.0000000000001243. eCollection 2025 Apr.

  PMID: 39917321 DERIVED

• Irwin MR, Carrillo C, Sadeghi N, Bjurstrom MF, Breen EC, Olmstead R. Prevention of Incident and Recurrent Major Depression in Older Adults With Insomnia: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Jan 1;79(1):33-41. doi: 10.1001/jamapsychiatry.2021.3422.

  PMID: 34817561 DERIVED

Related Links

• The UCLA Cousins Center Website

MeSH Terms

Conditions

Depression; Parasomnias

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Michael R Irwin, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Residence

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: July 16, 2012
• Study Start: July 1, 2012
• Primary Completion: April 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 30, 2020

Record last verified: 2020-09

Locations

US (1)