Primary Prevention of Major Depression in Later Life

NCT00326677 | Completed

• 1 other identifier: 0601117
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  Over the course of 2 years

Secondary Outcomes (1)

• 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

  over the course of 2 years

Interventions

Problem Solving Therapy BEHAVIORAL

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

Dietary Education BEHAVIORAL

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Maryland, College Park: lead
• University of Pittsburgh: collaborator

Study Sites (2)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (4)

• Altmann HM, Gebara MA, Albert SM, Morse JQ, Reynolds CF, Thomas SB, Stahl ST. Interpersonal Support Domains Associated With Symptoms of Posttraumatic Stress Among Older Black and White Adults. J Clin Psychiatry. 2023 May 29;84(4):22m14634. doi: 10.4088/JCP.22m14634.

  PMID: 37256634 DERIVED

• 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.

  PMID: 25107318 DERIVED

• 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.

  PMID: 24788282 DERIVED

• 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.

  PMID: 24632760 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Charles Reynolds III, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Health Services Administration and Director, Maryland Center for Health Equity

Study Record Dates

• First Submitted: May 15, 2006
• First Posted: May 17, 2006
• Study Start: May 1, 2006
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

US (2)