DepressionNCT00326677
Primary Prevention of Major Depression in Later Life
A study testing Problem Solving Therapy and Dietary Education in people with Depression, run by University of Maryland, College Park at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Problem Solving Therapy and Dietary Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 306 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2006to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Problem Solving Therapy, Dietary Education
- 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
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Solving TherapyBehavioural
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 EducationBehavioural
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
What is being measured
The primary outcome is the main question the study is designed to answer.
BDI, Hamilton, FDI scores, SCID diagnosis of major depression
Measured: 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
Measured: over the course of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2006 (estimated)
- Study startMay 2006
- Primary completionDec 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh
- Responsible party
- Principal investigator, Stephen Thomas, University of Maryland, College Park
- Investigators
- Charles Reynolds III, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326677
- Sponsor's protocol ID
- 0601117
- Status last verified
- Jan 2025
- First submitted
- 15 May 2006
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37256634Kasckow 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.
PubMed 25107318Stahl 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.
PubMed 24788282Reynolds 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.
PubMed 24632760
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Prevention of Major Depression in Later Life
- ClinicalTrials.gov ID
- NCT00326677
- Acronym / sponsor ID
- 0601117
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Collaborators
- University of Pittsburgh
- Study start
- May 2006 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Problem Solving Therapy6 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 | Behavioural | – |
| Dietary Education6 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 | Behavioural | – |
Primary outcome
BDI, Hamilton, FDI scores, SCID diagnosis of major depression
Time frame: Over the course of 2 years
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Derived from this study: PubMed 37256634Altmann 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.
- Derived from this study: PubMed 25107318Kasckow 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.
- Derived from this study: PubMed 24788282Stahl 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.
- Derived from this study: PubMed 24632760Reynolds 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Reynolds III, MD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem Solving Therapy and Dietary Education in people with Depression, run by University of Maryland, College Park at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BDI, Hamilton, FDI scores, SCID diagnosis of major depression (time frame: Over the course of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00326677, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.