- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01913366
Senior Peer Alliance for Rural Research On Wellness (SPARROW)
Case Management and Problem Solving Therapy for Depressed Older Adults
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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California
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Sonora, California, Stati Uniti, 95370
- Catholic Charities Motherlode Office- Sonora
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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;
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Hamilton Rating Scale for Depression (HRSD)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: Week 0
|
Generic assessment instrument for health and disability
|
Week 0
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WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Lasso di tempo: Week 3
|
Generic assessment instrument for health and disability
|
Week 3
|
|
WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Lasso di tempo: Week 6
|
Generic assessment instrument for health and disability
|
Week 6
|
|
WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Lasso di tempo: Week 12
|
Generic assessment instrument for health and disability
|
Week 12
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Brooke Hollister, Ph.D., University of California, San Francisco
- Investigatore principale: Patricia Arean, Ph.D., University of California, San Francisco
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- R01AG043584-01A1 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .