Clinical trial NCT00326677: Primary Prevention of Major Depression in Later Life
Official title: Primary Prevention of Major Depression in Later Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
First posted: 2006-05-17
Enrollment: 306
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.)

Primary outcomes:
measure: BDI, Hamilton, FDI scores, SCID diagnosis of major depression
timeFrame: Over the course of 2 years
Secondary outcomes:
measure: 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
timeFrame: over the course of 2 years
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Charles Reynolds III, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.