CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 308 enrolled
Drug / intervention
Sleep Education Therapy +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01641263
NCT01641263N/ACompleted

Aging: Sleep and Inflammatory Mechanism in Depression Prevention

University of California, Los Angeles·interventional·Posted Jul 16, 2012·Updated Sep 30, 2020

In Brief

A clinical study evaluating Sleep Education Therapy and Cognitve Behavioral Therapy for Insomnia for Depression. Completed, enrolled 308 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesUnited States

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 16, 2012
Enrollment StartJul 1, 2012
Primary CompletionApr 1, 2018
Study CompletionJul 1, 2018
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 14.0 years ago

Interventions

Sleep Education Therapybehavioral

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

Cognitve Behavioral Therapy for Insomniabehavioral

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.