- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01913366
Senior Peer Alliance for Rural Research On Wellness (SPARROW)
Case Management and Problem Solving Therapy for Depressed Older Adults
Study Overview
Detailed Description
If you are eligible to participate in the study after completing the screening assessment, and if you choose to continue on, we will randomize you (like a flip of a coin) to receive either 12 weeks of case management combined with problem solving therapy (CM-PST) with a social worker or 12 weeks of self-guided problem solving therapy (SG-PST) with support from a senior peer counselor.
As part of your participation in the study you will participate in three 1.5 hour assessment interviews of psychological and neuropsychological functioning (similar to your screening assessment) prior to your first week of treatment (baseline), two weeks after your final session (week 14), and three months after your final session (week 24). Additionally, you will participate in three shorter assessment interviews of psychological functioning, which will be conducted at weeks 3 and 6. These assessments will take approximately 30-45 minutes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
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Sonora, California, United States, 95370
- Catholic Charities Motherlode Office- Sonora
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Residence in rural Tuolumne, Calaveras, San Joaquin or Stanislaus Counties;
- Diagnosis: Major depression, unipolar (by SCID ascertained DSM-IV criteria);
- Severity of depression: A PHQ-9>10 or a 24-Item HDRS>19;
- Need for social services: CANE score> 2, i.e. at least one unmet need;
Exclusion Criteria:
- Psychotic depression by SCID-IV, i.e., presence of delusions;
- High suicide risk, i.e. intent or plan to attempt suicide in near future;
- Presence of any Axis I psychiatric disorder or substance abuse other than unipolar major depression;
- Axis II diagnosis of antisocial personality (by SCID-P and DSM-IV);
- History of psychiatric disorders other than unipolar major depression or generalized anxiety disorder (including bipolar disorder, hypomania, and dysthymia);
- Dementia: MMSE below 24 or clinical diagnosis of dementia by DSM-IV;
- Acute/severe medical illness (delirium, metastatic cancer, de-compensated cardiac, liver or kidney failure, stroke or myocardial infarction) 3 months prior to entry; or use of drugs causing depression, (steroids, reserpine, alphamethyl-dopa, tamoxiphen, vincristine);
- Inability to perform any of the ADLs (MAI: ADL subscale) even with assistance (walking with a cane is not an exclusion criterion)
- Inability to speak English;
- Aphasia interfering with communication;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CM-PST
If you are assigned to CM-PST, you will be working with the same care manager from your introductory session.
The care manager will continue to work with you on your problem-solving plan.
Additionally, you will receive case management services.
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|
Experimental: SG-PST
If you are assigned to SG-PST, you will continue to work on your problem-solving plan, using the self-guided materials provided to you during the introductory session.
Additionally, you will be partnered with a senior peer counselor who will support you in your SG-PST efforts.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hamilton Rating Scale for Depression (HRSD)
Time Frame: Baseline
|
A multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
|
Baseline
|
Hamilton Rating Scale for Depression (HRSD)
Time Frame: Week 3
|
A multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
|
Week 3
|
Hamilton Rating Scale for Depression (HRSD)
Time Frame: Week 6
|
A multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
|
Week 6
|
Hamilton Rating Scale for Depression (HRSD)
Time Frame: Week 12
|
A multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
|
Week 12
|
WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Time Frame: Week 0
|
Generic assessment instrument for health and disability
|
Week 0
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WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Time Frame: Week 3
|
Generic assessment instrument for health and disability
|
Week 3
|
WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Time Frame: Week 6
|
Generic assessment instrument for health and disability
|
Week 6
|
WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Time Frame: Week 12
|
Generic assessment instrument for health and disability
|
Week 12
|
Collaborators and Investigators
Investigators
- Principal Investigator: Brooke Hollister, Ph.D., University of California, San Francisco
- Principal Investigator: Patricia Arean, Ph.D., University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R01AG043584-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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