- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01913366
Senior Peer Alliance for Rural Research On Wellness (SPARROW)
Case Management and Problem Solving Therapy for Depressed Older Adults
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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California
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Sonora, California, Verenigde Staten, 95370
- Catholic Charities Motherlode Office- Sonora
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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;
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Experimenteel: 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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Hamilton Rating Scale for Depression (HRSD)
Tijdsspanne: Baseline
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A multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
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Baseline
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Hamilton Rating Scale for Depression (HRSD)
Tijdsspanne: Week 3
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A multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
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Week 3
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Hamilton Rating Scale for Depression (HRSD)
Tijdsspanne: Week 6
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A multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
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Week 6
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Hamilton Rating Scale for Depression (HRSD)
Tijdsspanne: Week 12
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A multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
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Week 12
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WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Tijdsspanne: Week 0
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Generic assessment instrument for health and disability
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Week 0
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WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Tijdsspanne: Week 3
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Generic assessment instrument for health and disability
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Week 3
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WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Tijdsspanne: Week 6
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Generic assessment instrument for health and disability
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Week 6
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WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Tijdsspanne: Week 12
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Generic assessment instrument for health and disability
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Week 12
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Brooke Hollister, Ph.D., University of California, San Francisco
- Hoofdonderzoeker: Patricia Arean, Ph.D., University of California, San Francisco
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- R01AG043584-01A1 (Subsidie/contract van de Amerikaanse NIH)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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