{"type":"trials","record":{"id":32544,"source_id":"clinicaltrials-gov","external_id":"NCT01641263","title":"Promoting Sleep and Healthy Aging Research Study (PRO-SHARE)","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.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"University of California, Los Angeles","enrollment":308,"countries":["United States"],"start_date":"2012-07-01","completion_date":"2018-07-01","last_update_date":"2020-09-30","source_url":"https://clinicaltrials.gov/study/NCT01641263","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:20:02.68364+00:00","last_seen_at":"2026-09-25T06:05:15.478+00:00","metadata":{"sex":"ALL","acronym":"PRO-SHARE","age_range":"60 Years","comparator":"Sleep Seminar","organization":"University of California, Los Angeles","interventions":["Sleep Education Therapy","Cognitve Behavioral Therapy for Insomnia"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change in depression from baseline — Up to 3 years","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","Change in Sleep disturbance from baseline — Up to 3 years"],"design_description":"RANDOMIZED · PARALLEL · PREVENTION · SINGLE","source_has_results":false},"controlled_terms":["Depression","Sleep Education Therapy","Cognitve Behavioral Therapy for Insomnia"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Title contains controlled term: sleep.","quality_checked_at":"2026-09-25T06:05:18.114262+00:00","duplicate_cluster_key":"id:nct01641263","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2012-07-01 to 2018-07-01","comparator":"Sleep Seminar","confidence":"structured-source","population":"ALL · 60 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:05:15.509Z","intervention":["Sleep Education Therapy","Cognitve Behavioral Therapy for Insomnia"],"participants":308,"study_design":"RANDOMIZED · PARALLEL · PREVENTION · SINGLE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Change in depression from baseline — Up to 3 years","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","Change in Sleep disturbance from baseline — Up to 3 years"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"sleep","is_published":true,"match_reasons":["Title contains controlled term: sleep.","Abstract contains controlled term: sleep.","Source terminology contains: sleep.","Title supplies longevity context: aging.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Sleep","slug":"sleep"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/32544","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}