NCT01913366

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

5 years

First QC Date

July 29, 2013

Last Update Submit

July 30, 2019

Conditions

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (2)

CM-PST

EXPERIMENTAL

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

SG-PST

EXPERIMENTAL

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

Interventions

CM-PSTBEHAVIORAL
CM-PST
SG-PSTBEHAVIORAL
SG-PST

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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 speak English;
  • Aphasia interfering with communication;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic Charities Motherlode Office- Sonora

Sonora, California, 95370, United States

Location

Study Officials

  • Brooke Hollister, Ph.D.

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
  • Patricia Arean, Ph.D.

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2013

First Posted

August 1, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2018

Study Completion

March 31, 2019

Last Updated

July 31, 2019

Record last verified: 2019-07

Locations