DepressionNCT00540865
Effectiveness of Case Management Versus Case Management Plus Problem-solving Therapy to Treat Depression in Low-income Elders
A study testing Problem-solving therapy (PST) and Case management (CM) in people with Depression, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial summary
This study will compare the effectiveness of case management combined with problem-solving therapy (CM-PST) versus case management (CM) alone for assisting elderly people with depression. Read more about this study
- Who is it for?
- Ages 60 to 95 years
- Conditions the study is for
- Depression
- What is being tested?
- Problem-solving therapy (PST) and Case management (CM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2007to Oct 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 60 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receives home-delivered meal service
- Has at least one instrumental activity of daily living (IADL) impairment
- Meets Diagnostic and Statistical Manual of Mental Disorders (DSM)IV criteria for unipolar major depression
- Considered low income (30% of the local median income)
- Has a need for social services
- Experiences problem-solving difficulties
- Speaks English
Who cannot join
- Diagnosis of psychotic depression or experiences delusions
- Suicidal
- Diagnosed with any Axis I psychiatric disorder other than unipolar major depression
- History of substance abuse
- Axis II diagnosis of antisocial personality
- History of psychiatric disorders other than unipolar major depression or generalized anxiety disorder, such as bipolar disorder, hypomania, or dysthymia
Show all 13Show fewer
- Diagnosed with dementia
- Acute or severe medical illness, such as delirium, metastatic cancer, major surgery, stroke, heart attack, or decompensated heart, liver, or kidney failure within 3 months of study entry
- Use of drugs known to cause depression, such as steroids, reserpine, alpha-methyl-dopa, tamoxifen, or vincristine
- Use of antidepressants
- Currently receiving psychotherapy
- Inability to perform any of the activities of daily living (ADLs) even with assistance
- Aphasia interfering with communication
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California - San Francisco
San Francisco, California, 94143
Weill Medical College of Cornell University
White Plains, New York, 10605
About this study
Official title: Case Management and Problem Solving Therapy for Depressed, Homebound, Low-Income Elders
This study will compare the effectiveness of case management combined with problem-solving therapy (CM-PST) versus case management (CM) alone for assisting elderly people with depression.
Read the detailed description
Depression is a common mental disorder that affects many low-income elders. Many elders suffer from multiple chronic illnesses and often must deal with social and financial hardships as they continue to age. Rates of diagnosis and treatment for depression within the elderly population are low. This may be because elders are embarrassed to discuss their symptoms with their doctor and assume sadness and anxiety are a normal part of the aging process. However, depression is not a normal consequence of aging. Furthermore, it can severely impact people's lives, sleep patterns, concentration, and energy levels. This study will compare the effectiveness of case management combined with problem-solving therapy (CM-PST) versus case management (CM) alone for assisting elderly people diagnosed with depression.
CM involves identifying a person's particular needs and working with a case worker to plan and implement specific resources and services that will meet those needs. PST emphasizes the social context of an individual's situation through problem-solving and behavior change techniques. Recent studies have suggested that combining CM with PST may have a mutually beneficial effect on depressed, low-income elders. CM can help elders with their social and financial needs, and PST can improve their ability to cope with stressful events and utilize their new resources.
Participants in this open-label study will be randomly assigned to receive 12 sessions of either CM or CM-PST. Both treatments will be delivered at the participant's home by a trained case worker. Participants assigned to receive CM will focus on increasing their resources and reducing adversity. The case worker will help participants determine the causes of their unmet needs, create an action plan to meet those needs, encourage the use of services, and possibly advise their family members and health care providers to help facilitate the use of those services. Participants assigned to CM-PST will undergo a needs assessment during the first session to develop a problem-solving plan that will be implemented over the next 11 sessions. Each session will include instruction on how to use the PST approach to solve problems identified by both the therapist and participant. All participants will undergo a neuropsychological exam and complete psychological and physical functioning questionnaires prior to treatment and at Weeks 3, 6, 12, and 24.
- Conditions
- Depression
- Being tested
- Problem-solving therapy (PST), Case management (CM)
- Keywords
- Homebound Persons, Case Management, Problem Solving Therapy
- 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 therapy (PST)Behavioural
The premise of PST is that psychotherapies implicitly help people to become better managers of their lives, in effect, to become better at solving problems. Unlike Case Management (CM) that seeks to increase its clients' availability and utilization of resources, PST focuses on the patients themselves and helps them develop skills in identifying, prioritizing, and solving problems, and thereby creates a sense of empowerment. Although CM and PST have different theoretical premises, they both focus on the resolution of concrete problems promoting depression.
Case management (CM)Behavioural
Different types of CM exist, but all share the theme of helping individuals cope with their illnesses through linkage to social services, advocacy, rehabilitation, and ongoing support during recovery from illnesses. CM will consist of the following components: 1) socialization to treatment; 2) needs assessment; 3) psychoeducation about depression; 4) service planning; 5) linkage to social services; 6) help with access to health care; 7) advocacy; and 8) exploration of barriers that perpetuate unmet needs.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Participants will receive problem-solving therapy and case management Receives: Behavioral: Problem-solving therapy (PST); Behavioral: Case management (CM) |
| B | Active comparator | Participants will receive case management Receives: Behavioral: Case management (CM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Measured: Measured at pretreatment and Weeks 3, 6, 9, 12, and 24
Secondary outcomes (1)
Disability
Measured: Measured at pretreatment and Weeks 3, 6, 9, 12, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startMay 2007
- Primary completionJul 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- George S. Alexopoulos, MD, Principal investigator, Weill Medical College of Cornell UniversityPatricia A. Arean, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540865
- Sponsor's protocol ID
- R01MH075897
- Other IDs
- R01MH075897, 0604008461 DATR A4-GPS
- Status last verified
- Dec 2014
- First submitted
- 4 Oct 2007
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Solomonov N, Kerchner D, Bein O, Lee CE, Diaz JL, Ciarleglio A, Kim S, Sirey JA, Gunning FM, Raue PJ, Banerjee S, Arean PA, Alexopoulos GS. Precision Assignment to Psychosocial Interventions for Late-Life Depression: An Automated Treatment Decision Rule. JAMA Psychiatry. 2025 Nov 1;82(11):1075-1084. doi: 10.1001/jamapsychiatry.2025.2518.
PubMed 40960814Arean PA, Hallgren KA, Jordan JT, Gazzaley A, Atkins DC, Heagerty PJ, Anguera JA. The Use and Effectiveness of Mobile Apps for Depression: Results From a Fully Remote Clinical Trial. J Med Internet Res. 2016 Dec 20;18(12):e330. doi: 10.2196/jmir.6482.
PubMed 27998876Anguera JA, Jordan JT, Castaneda D, Gazzaley A, Arean PA. Conducting a fully mobile and randomised clinical trial for depression: access, engagement and expense. BMJ Innov. 2016 Jan;2(1):14-21. doi: 10.1136/bmjinnov-2015-000098.
PubMed 27019745Arean PA, Raue PJ, McCulloch C, Kanellopoulos D, Seirup JK, Banerjee S, Kiosses DN, Dwyer E, Alexopoulos GS. Effects of Problem-Solving Therapy and Clinical Case Management on Disability in Low-Income Older Adults. Am J Geriatr Psychiatry. 2015 Dec;23(12):1307-1314. doi: 10.1016/j.jagp.2015.04.005. Epub 2015 Apr 24.
PubMed 26628206Alexopoulos GS, Raue PJ, McCulloch C, Kanellopoulos D, Seirup JK, Sirey JA, Banerjee S, Kiosses DN, Arean PA. Clinical Case Management versus Case Management with Problem-Solving Therapy in Low-Income, Disabled Elders with Major Depression: A Randomized Clinical Trial. Am J Geriatr Psychiatry. 2016 Jan;24(1):50-59. doi: 10.1016/j.jagp.2015.02.007. Epub 2015 Feb 17.
PubMed 25794636
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Management and Problem Solving Therapy for Depressed, Homebound, Low-Income Elders
- ClinicalTrials.gov ID
- NCT00540865
- Acronym / sponsor ID
- R01MH075897
- Conditions
- Depression
- Keywords
- Homebound Persons, Case Management, Problem Solving Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2007
- Primary completion
- Jul 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 8 Oct 2007 (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.
This study will compare the effectiveness of case management combined with problem-solving therapy (CM-PST) versus case management (CM) alone for assisting elderly people with depression.
Detailed description
Depression is a common mental disorder that affects many low-income elders. Many elders suffer from multiple chronic illnesses and often must deal with social and financial hardships as they continue to age. Rates of diagnosis and treatment for depression within the elderly population are low. This may be because elders are embarrassed to discuss their symptoms with their doctor and assume sadness and anxiety are a normal part of the aging process. However, depression is not a normal consequence of aging. Furthermore, it can severely impact people's lives, sleep patterns, concentration, and energy levels. This study will compare the effectiveness of case management combined with problem-solving therapy (CM-PST) versus case management (CM) alone for assisting elderly people diagnosed with depression.
CM involves identifying a person's particular needs and working with a case worker to plan and implement specific resources and services that will meet those needs. PST emphasizes the social context of an individual's situation through problem-solving and behavior change techniques. Recent studies have suggested that combining CM with PST may have a mutually beneficial effect on depressed, low-income elders. CM can help elders with their social and financial needs, and PST can improve their ability to cope with stressful events and utilize their new resources.
Participants in this open-label study will be randomly assigned to receive 12 sessions of either CM or CM-PST. Both treatments will be delivered at the participant's home by a trained case worker. Participants assigned to receive CM will focus on increasing their resources and reducing adversity. The case worker will help participants determine the causes of their unmet needs, create an action plan to meet those needs, encourage the use of services, and possibly advise their family members and health care providers to help facilitate the use of those services. Participants assigned to CM-PST will undergo a needs assessment during the first session to develop a problem-solving plan that will be implemented over the next 11 sessions. Each session will include instruction on how to use the PST approach to solve problems identified by both the therapist and participant. All participants will undergo a neuropsychological exam and complete psychological and physical functioning questionnaires prior to treatment and at Weeks 3, 6, 12, and 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Problem-solving therapy (PST), Behavioral: Case management (CM)Participants will receive problem-solving therapy and case management |
| B | Active comparator | Behavioral: Case management (CM)Participants will receive case management |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Receives home-delivered meal service
- Has at least one instrumental activity of daily living (IADL) impairment
- Meets Diagnostic and Statistical Manual of Mental Disorders (DSM)IV criteria for unipolar major depression
- Considered low income (30% of the local median income)
- Has a need for social services
Key exclusion criteria (13 listed)
- Diagnosis of psychotic depression or experiences delusions
- Suicidal
- Diagnosed with any Axis I psychiatric disorder other than unipolar major depression
- History of substance abuse
- Axis II diagnosis of antisocial personality
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 therapy (PST)The premise of PST is that psychotherapies implicitly help people to become better managers of their lives, in effect, to become better at solving problems. Unlike Case Management (CM) that seeks to increase its clients' availability and utilization of resources, PST focuses on the patients themselves and helps them develop skills in identifying, prioritizing, and solving problems, and thereby creates a sense of empowerment. Although CM and PST have different theoretical premises, they both focus on the resolution of concrete problems promoting depression. | Behavioural | A |
| Case management (CM)Different types of CM exist, but all share the theme of helping individuals cope with their illnesses through linkage to social services, advocacy, rehabilitation, and ongoing support during recovery from illnesses. CM will consist of the following components: 1) socialization to treatment; 2) needs assessment; 3) psychoeducation about depression; 4) service planning; 5) linkage to social services; 6) help with access to health care; 7) advocacy; and 8) exploration of barriers that perpetuate unmet needs. | Behavioural | A, B |
Primary outcome
Depression
Time frame: Measured at pretreatment and Weeks 3, 6, 9, 12, and 24
1 secondary outcome
Disability
Time frame: Measured at pretreatment and Weeks 3, 6, 9, 12, and 24
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 10 Dec 2014.
- Derived from this study: PubMed 40960814Solomonov N, Kerchner D, Bein O, Lee CE, Diaz JL, Ciarleglio A, Kim S, Sirey JA, Gunning FM, Raue PJ, Banerjee S, Arean PA, Alexopoulos GS. Precision Assignment to Psychosocial Interventions for Late-Life Depression: An Automated Treatment Decision Rule. JAMA Psychiatry. 2025 Nov 1;82(11):1075-1084. doi: 10.1001/jamapsychiatry.2025.2518.
- Derived from this study: PubMed 27998876Arean PA, Hallgren KA, Jordan JT, Gazzaley A, Atkins DC, Heagerty PJ, Anguera JA. The Use and Effectiveness of Mobile Apps for Depression: Results From a Fully Remote Clinical Trial. J Med Internet Res. 2016 Dec 20;18(12):e330. doi: 10.2196/jmir.6482.
- Derived from this study: PubMed 27019745Anguera JA, Jordan JT, Castaneda D, Gazzaley A, Arean PA. Conducting a fully mobile and randomised clinical trial for depression: access, engagement and expense. BMJ Innov. 2016 Jan;2(1):14-21. doi: 10.1136/bmjinnov-2015-000098.
- Derived from this study: PubMed 26628206Arean PA, Raue PJ, McCulloch C, Kanellopoulos D, Seirup JK, Banerjee S, Kiosses DN, Dwyer E, Alexopoulos GS. Effects of Problem-Solving Therapy and Clinical Case Management on Disability in Low-Income Older Adults. Am J Geriatr Psychiatry. 2015 Dec;23(12):1307-1314. doi: 10.1016/j.jagp.2015.04.005. Epub 2015 Apr 24.
- Derived from this study: PubMed 25794636Alexopoulos GS, Raue PJ, McCulloch C, Kanellopoulos D, Seirup JK, Sirey JA, Banerjee S, Kiosses DN, Arean PA. Clinical Case Management versus Case Management with Problem-Solving Therapy in Low-Income, Disabled Elders with Major Depression: A Randomized Clinical Trial. Am J Geriatr Psychiatry. 2016 Jan;24(1):50-59. doi: 10.1016/j.jagp.2015.02.007. Epub 2015 Feb 17.
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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.
George S. Alexopoulos, MD principal investigator
Weill Medical College of Cornell University
Patricia A. Arean, PhD principal investigator
University of California, San Francisco
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 (PST) and Case management (CM) in people with Depression, run by Weill Medical College of Cornell University 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 7 inclusion and 13 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 10 Dec 2014. 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?
Depression (time frame: Measured at pretreatment and Weeks 3, 6, 9, 12, and 24). 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 NCT00540865, which also lists 5 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 10 Dec 2014.