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Completed

NCT Number: NCT01913366

Senior Peer Alliance for Rural Research On Wellness

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.

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Key information

Conditions

MDD

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic Charities Motherlode Office- Sonora

Sonora, California, 95370, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

CM-PST

Behavioral

SG-PST

Behavioral

Primary outcomes

  1. 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.

  2. 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.

  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.

  4. 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.

  5. WHO Disability Assessment Schedule 2.0 (WHODAS-II)

    Time frame: Week 0

    Generic assessment instrument for health and disability

  6. WHO Disability Assessment Schedule 2.0 (WHODAS-II)

    Time frame: Week 3

    Generic assessment instrument for health and disability

  7. WHO Disability Assessment Schedule 2.0 (WHODAS-II)

    Time frame: Week 6

    Generic assessment instrument for health and disability

  8. WHO Disability Assessment Schedule 2.0 (WHODAS-II)

    Time frame: Week 12

    Generic assessment instrument for health and disability

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Case Management and Problem Solving Therapy for Depressed Older Adults

Acronym: SPARROW

Important dates

Study start
2013
Primary completion
2018
Study completion
2019
First posted
Aug 1, 2013
Registry last updated
Jul 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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