Clinical trial NCT00540865: Effectiveness of Case Management Versus Case Management Plus Problem-solving Therapy to Treat Depression in Low-income Elders
Official title: Case Management and Problem Solving Therapy for Depressed, Homebound, Low-Income Elders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Homebound Persons
Case Management
Problem Solving Therapy
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2007-10-08
Enrollment: 187
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Depression
timeFrame: Measured at pretreatment and Weeks 3, 6, 9, 12, and 24
Secondary outcomes:
measure: Disability
timeFrame: Measured at pretreatment and Weeks 3, 6, 9, 12, and 24
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California - San Francisco
state: California
city: White Plains
country: United States
facility: Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: George S. Alexopoulos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Patricia A. Arean, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arean 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.
citation: Anguera 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.
citation: Arean 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.
citation: Alexopoulos 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.