NCT00318864

Brief Summary

The purpose of this study is to determine if improvements in mood will ameliorate autonomic dysregulation, HPA dysfunction and typical (e.g. lipids) and atypical risk factors in depressed patients with elevated cardiovascular risk (CVD). Up to 70, depressed participants with elevated cardiovascular risk factors were randomized to a cognitive behavioral intervention (CBT) or a waiting list control (WLC) condition. Twenty non-depressed age and risk-matched controls will also recruited. Traditional risk factors (e.g. lipids, blood pressure, heart rate), atypical risk factors (endothelial function, asymmetric dimethylarginine, C-reactive protein) will be measured pre and post treatment six months later Subjects will undergo a psychophysiological stress test while cardiovascular physiology was measured. Salivary cortisol will be measured during the day and during the psychological stress test. Depressed subjects will be randomized to a 16 week cognitive behavior therapy intervention or to a wait-list control. It is hypothesized that reduction in mood will be associated with reduction in typical and atypical risk factors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Jun 2002

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
Last Updated

April 27, 2006

Status Verified

April 1, 2006

First QC Date

April 25, 2006

Last Update Submit

April 25, 2006

Conditions

DepressionHypertensionHypercholesterolemia

Keywords

depressioncardiovascular riskmechanisms

Outcome Measures

Primary Outcomes (1)

  • Change in depression

Secondary Outcomes (1)

  • Change in typical and atypical risk factors

Interventions

Cognitive behavioral therapyBEHAVIORAL

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 55 years, hypertensive or hypercholesterolemic, depressed

You may not qualify if:

  • suicidal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Medical Center

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

DepressionHypertensionHypercholesterolemia

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorVascular DiseasesCardiovascular DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Craig B Taylor

    Stanford Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 25, 2006

First Posted

April 27, 2006

Study Start

June 1, 2002

Study Completion

July 1, 2005

Last Updated

April 27, 2006

Record last verified: 2006-04

Locations

US(1)