This trial is active, not recruiting.

Condition depression
Treatments problem solving therapy, dietary education
Sponsor University of Pittsburgh
Start date May 2006
End date June 2012
Trial size 306 participants
Trial identifier NCT00326677, 0601117


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention

Primary Outcomes

BDI, Hamilton, FDI scores, SCID diagnosis of major depression
time frame: Over the course of 2 years

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 50 years old.

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.)

Additional Information

Official title Primary Prevention of Major Depression in Later Life
Principal investigator Charles Reynolds III, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2011.
Information provided to ClinicalTrials.gov by University of Pittsburgh.