NCT00540865

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2007

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

December 10, 2014

Status Verified

December 1, 2014

Enrollment Period

6.2 years

First QC Date

October 4, 2007

Last Update Submit

December 9, 2014

Conditions

Depression

Keywords

Homebound PersonsCase ManagementProblem Solving Therapy

Outcome Measures

Primary Outcomes (1)

  • Depression

    Measured at pretreatment and Weeks 3, 6, 9, 12, and 24

Secondary Outcomes (1)

  • Disability

    Measured at pretreatment and Weeks 3, 6, 9, 12, and 24

Study Arms (2)

A

EXPERIMENTAL

Participants will receive problem-solving therapy and case management

Behavioral: Problem-solving therapy (PST)Behavioral: Case management (CM)

B

ACTIVE COMPARATOR

Participants will receive case management

Behavioral: Case management (CM)

Interventions

Problem-solving therapy (PST)BEHAVIORAL

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.

A
Case management (CM)BEHAVIORAL

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.

AB

Eligibility Criteria

Age60 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California - San Francisco

San Francisco, California, 94143, United States

Location

Weill Medical College of Cornell University

White Plains, New York, 10605, United States

Location

Related Publications (5)

  • 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.

    PMID: 40960814DERIVED

  • 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.

    PMID: 27998876DERIVED

  • 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.

    PMID: 27019745DERIVED

  • 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.

    PMID: 26628206DERIVED

  • 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.

    PMID: 25794636DERIVED

MeSH Terms

Conditions

Depression

Interventions

Case Management

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • George S. Alexopoulos, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

  • Patricia A. Arean, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2007

First Posted

October 8, 2007

Study Start

May 1, 2007

Primary Completion

July 1, 2013

Study Completion

October 1, 2013

Last Updated

December 10, 2014

Record last verified: 2014-12

Locations

US(2)