Clinical trial NCT01913366: Senior Peer Alliance for Rural Research On Wellness
Official title: Case Management and Problem Solving Therapy for Depressed Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: MDD
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2013-08-01
Enrollment: 105
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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;

Primary outcomes:
measure: Hamilton Rating Scale for Depression (HRSD)
timeFrame: Baseline
measure: Hamilton Rating Scale for Depression (HRSD)
timeFrame: Week 3
measure: Hamilton Rating Scale for Depression (HRSD)
timeFrame: Week 6
measure: Hamilton Rating Scale for Depression (HRSD)
timeFrame: Week 12
measure: WHO Disability Assessment Schedule 2.0 (WHODAS-II)
timeFrame: Week 0
measure: WHO Disability Assessment Schedule 2.0 (WHODAS-II)
timeFrame: Week 3
measure: WHO Disability Assessment Schedule 2.0 (WHODAS-II)
timeFrame: Week 6
measure: WHO Disability Assessment Schedule 2.0 (WHODAS-II)
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Sonora
country: United States
facility: Catholic Charities Motherlode Office- Sonora
state: California
Study officials:
affiliation: University of California, San Francisco
name: Brooke Hollister, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Patricia Arean, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: