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Primary Prevention of Major Depression in Later Life

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Problem Solving Therapy
Dietary Education
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring 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

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • University of Pittsburgh Medical Center
  • University of Pittsburgh

Outcomes

Primary Outcome Measures

BDI, Hamilton, FDI scores, SCID diagnosis of major depression

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

Full Information

First Posted
May 15, 2006
Last Updated
February 17, 2011
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT00326677
Brief Title
Primary Prevention of Major Depression in Later Life
Official Title
Primary Prevention of Major Depression in Later Life
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2006 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
306 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Problem Solving Therapy
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Dietary Education
Intervention Description
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
Primary Outcome Measure Information:
Title
BDI, Hamilton, FDI scores, SCID diagnosis of major depression
Time Frame
Over the course of 2 years
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Reynolds III, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25107318
Citation
Kasckow J, Morse J, Begley A, Anderson S, Bensasi S, Thomas S, Quinn SC, Reynolds CF 3rd. Treatment of post traumatic stress disorder symptoms in emotionally distressed individuals. Psychiatry Res. 2014 Dec 15;220(1-2):370-5. doi: 10.1016/j.psychres.2014.06.043. Epub 2014 Jun 28.
Results Reference
derived
PubMed Identifier
24788282
Citation
Stahl ST, Albert SM, Dew MA, Lockovich MH, Reynolds CF 3rd. Coaching in healthy dietary practices in at-risk older adults: a case of indicated depression prevention. Am J Psychiatry. 2014 May;171(5):499-505. doi: 10.1176/appi.ajp.2013.13101373.
Results Reference
derived
PubMed Identifier
24632760
Citation
Reynolds CF 3rd, Thomas SB, Morse JQ, Anderson SJ, Albert S, Dew MA, Begley A, Karp JF, Gildengers A, Butters MA, Stack JA, Kasckow J, Miller MD, Quinn SC. Early intervention to preempt major depression among older black and white adults. Psychiatr Serv. 2014 Jun 1;65(6):765-73. doi: 10.1176/appi.ps.201300216.
Results Reference
derived

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Primary Prevention of Major Depression in Later Life

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