Primary Prevention of Major Depression in Later Life

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00326677
First received: May 15, 2006
Last updated: February 17, 2011
Last verified: February 2011
  Purpose

The Institute of Medicine has called for studies of "indicated" preventive interventions to reduce the incidence of mental illness in persons already symptomatic but not yet presenting with fully developed clinical syndromes.

The investigators' Advanced Center for Interventions and Services Research in Late Life Mood Disorders has embraced the development and testing of preventive interventions as one of its key objectives. The investigators propose to test the following hypotheses related to primary prevention of major depressive episodes in old age, focusing on elderly patients who have symptoms of emotional distress but who are not yet presenting with the full syndrome of a major depressive episode.

Hypothesis 1: Problem solving therapy (PST) will be superior to an attention-only control (dietary education) in lowering the two-year incidence of episodes of syndromal major depression in already symptomatic elderly primary care patients.

Hypothesis 2: PST will also prevent higher levels of depressive symptoms and associated disabilities, over a two-year period of follow-up.


Condition Intervention
Depression
Behavioral: Problem Solving Therapy
Behavioral: Dietary Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Primary Prevention of Major Depression in Later Life

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • BDI, Hamilton, FDI scores, SCID diagnosis of major depression [ Time Frame: Over the course of 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CES-D, ISEL,Folstein Mini-Mental, MOS-SF8,BSI, EXIT, Hopkins Verbal Learning Test, PTSD Checklist, Social Problem Solving Inventory, PSQI, CIRS-G, RAND 12 [ Time Frame: over the course of 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 306
Study Start Date: May 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Problem Solving Therapy
    6 to 8 Problem Solving Therapy sessions over the course of 6 to 16 weeks followed by 3 booster PST sessions over the course of 2 years
    Behavioral: Dietary Education
    6 to 8 Diet Education sessions over the course of 6 to 16 weeks followed by 3 booster Diet Education sessions over the course of 2 years
Detailed Description:

306 participants will be randomly assigned to either problem solving therapy or to a dietary education control. PST will consist of 6 to 8 sessions, distributed over 6 to 16 weeks, teaching participants a structured process of problem definition, generation of potential solutions, evaluation and choice of solution, and its implementation. The dietary education control will consist of 6 to 8 sessions also, distributed over 6 to 16 weeks. Subjects assigned to the DIET condition will receive education in healthy eating practices (e.g., food pyramid, types of food and calories recommended for people age 60 and above, tips on shopping for healthy food, food preparation, and healthy eating behavior). Subjects will be followed up to 2 years. Length of study is 24 months.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 50 or greater
  • Center for Epidemiological Studies of Depression Scale (CES-D) score of 11 or higher
  • Folstein Mini-Mental State score of 24 or higher
  • Not currently receiving antidepressant medication or participating in other mental health treatment

Exclusion Criteria:

  • Episode of major depression within the past 12 months
  • Episode of alcohol or other substance abuse within the past 12 months
  • Life time history of bipolar disorder or other psychotic disorder
  • Diagnosis of any neurodegenerative disorder or of dementia (Alzheimer's, vascular, or frontotemporal dementia, etc.)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00326677

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Charles Reynolds III, MD University of Pittsburgh
  More Information

Additional Information:
No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Charles F. Reynolds III, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00326677     History of Changes
Other Study ID Numbers: 0601117
Study First Received: May 15, 2006
Last Updated: February 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Depression Prevention
Prevention of Depression
Depression in the Elderly
Late Life Depression
Depression in Old Age
Treatment of Depression in Primary Care Patients
Sub syndromal depression
Minor Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 01, 2014