Senior Peer Alliance for Rural Research On Wellness

MDD Clinical Trial

— SPARROW  

Official title:

Case Management and Problem Solving Therapy for Depressed Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01913366
• Other study ID #: R01AG043584-01A1
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: March 31, 2019

Study information

• Verified date: July 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: March 31, 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• MDD

Intervention

Behavioral:
• CM-PST

• SG-PST

Locations

Country	Name	City	State
United States	Catholic Charities Motherlode Office- Sonora	Sonora	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	WHO Disability Assessment Schedule 2.0 (WHODAS-II)	Generic assessment instrument for health and disability	Week 0
Primary	WHO Disability Assessment Schedule 2.0 (WHODAS-II)	Generic assessment instrument for health and disability	Week 3
Primary	WHO Disability Assessment Schedule 2.0 (WHODAS-II)	Generic assessment instrument for health and disability	Week 6
Primary	WHO Disability Assessment Schedule 2.0 (WHODAS-II)	Generic assessment instrument for health and disability	Week 12