Senior Peer Alliance for Rural Research On Wellness

Study Overview
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Brief Summary
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Dr. Brooke Hollister, Ph.D. from the department of Social and Behavioral Sciences at the University of California, San Francisco is conducting a study comparing two types of interventions for treating depression in rural older adults.

Detailed Description
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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.

Official Title
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Case Management and Problem Solving Therapy for Depressed Older Adults

Conditions
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MDD

Intervention / Treatment
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* Behavioral: CM-PST
* Behavioral: SG-PST


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CM-PST<br>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. | Behavioral: CM-PST<br> <br> |
| Experimental: SG-PST<br>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. | Behavioral: SG-PST<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for Depression (HRSD) | 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) | 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) | 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) | 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) | Generic assessment instrument for health and disability | Week 0 | 
| WHO Disability Assessment Schedule 2.0 (WHODAS-II) | Generic assessment instrument for health and disability | Week 3 | 
| WHO Disability Assessment Schedule 2.0 (WHODAS-II) | Generic assessment instrument for health and disability | Week 6 | 
| WHO Disability Assessment Schedule 2.0 (WHODAS-II) | Generic assessment instrument for health and disability | Week 12 |