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Senior Peer Alliance for Rural Research On Wellness (SPARROW)

30. juli 2019 opdateret af: University of California, San Francisco

Case Management and Problem Solving Therapy for Depressed Older Adults

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

105

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Sonora, California, Forenede Stater, 95370
        • Catholic Charities Motherlode Office- Sonora

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

60 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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;

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: CM-PST
Eksperimentel: 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.
Adfærdsmæssigt: SG-PST

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hamilton Rating Scale for Depression (HRSD)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Week 0
Generic assessment instrument for health and disability
Week 0
WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Tidsramme: Week 3
Generic assessment instrument for health and disability
Week 3
WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Tidsramme: Week 6
Generic assessment instrument for health and disability
Week 6
WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Tidsramme: Week 12
Generic assessment instrument for health and disability
Week 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, San Francisco

Efterforskere

  • Ledende efterforsker: Brooke Hollister, Ph.D., University of California, San Francisco
  • Ledende efterforsker: Patricia Arean, Ph.D., University of California, San Francisco

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2013

Primær færdiggørelse (Faktiske)

1. august 2018

Studieafslutning (Faktiske)

31. marts 2019

Datoer for studieregistrering

Først indsendt

29. juli 2013

Først indsendt, der opfyldte QC-kriterier

29. juli 2013

Først opslået (Skøn)

1. august 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. juli 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juli 2019

Sidst verificeret

1. juli 2019

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • R01AG043584-01A1 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner