A Family-based Primary Care Intervention to Enhance Older Men's Depression Care
Primary Purpose
Major Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family-based depression intervention
Usual care plus educational materials
Sponsored by
About this trial
This is an interventional treatment trial for Major Depression focused on measuring depression, family, primary health care
Eligibility Criteria
Inclusion Criteria:
- Men, age 50 and above
- English or Spanish speaking
- Score of >9 on the PHQ-9
- Non-demented
- Have an adult family member or close friend who can participate
Exclusion Criteria:
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Sites / Locations
- San Joaquin General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Family-based depression intervention
Usual care plus educational materials
Arm Description
The family-focused component will consist of up to up to 10 joint (i.e. older man alone and/or with family members) sessions that will cover specific topics related to family support of men's depression care provided by a clinic-based social worker
Control subjects will receive usual care in the clinic enhanced by a single depression psychoeducation session.
Outcomes
Primary Outcome Measures
Depressive Symptoms
Patient Health Questionnaire (PHQ-9) scale; 0-27 scoring units; higher scores indicate more severe depressive symptoms.
Secondary Outcome Measures
Full Information
NCT ID
NCT02143024
First Posted
June 19, 2013
Last Updated
January 6, 2020
Sponsor
University of California, Davis
Collaborators
University of Washington, RAND
1. Study Identification
Unique Protocol Identification Number
NCT02143024
Brief Title
A Family-based Primary Care Intervention to Enhance Older Men's Depression Care
Official Title
A Family-based Primary Care Intervention to Enhance Older Men's Depression Care
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2015 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
University of Washington, RAND
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Despite the public health importance of clinical depression, more than 50% of depressed adults receive inadequate or no treatment, with even higher rates of under-treatment in men and minorities. Family members and/or friends often assist older adults in their health care and may help overcome barriers to formal care, yet there is a lack of primary care-based interventions that mobilize family members and friends to improve depression treatment. In partnership with a community-based clinic, this research will address this scientific gap by developing and then testing the feasibility and acceptability of a family-based intervention that can be delivered pragmatically in a primary care setting serving large numbers of older minorities.
Detailed Description
The family-based intervention will be tested in a 6 month randomized controlled trial of 24 depressed older men-family member dyads (18 intervention and 6 controls). The purpose of the RCT is to test the acceptability of the intervention, as well as the feasibility of the study methods. Patients from the RCT will be identified from a family practice clinic based on their scores on the PHQ-9 as well as additional inclusion and exclusion criteria. Once they and their family member have agreed to participate, patients will be randomized either to the family based intervention or a usual care control condition augmented by family psychoeducation. The investigators will recruit English and Spanish speaking age 60 and above older men from SJGH who have 1) significant depressive symptoms (i.e. PHQ > 15, 2) have at least one criteria A symptom (depressed mood or anhedonia), 3) depression-related functional impairment) and 4) an adult family member willing to participate in the study. We have chosen a higher cut-off to minimize false positives. We will exclude psychotic, demented or institutionalized men. After enrollment, 24 dyads (i.e. older man and family member) will be randomized one of two groups: intervention or usual care augmented by written psychoeducational materials on depression. Dyads will be randomized to achieve a 2:1 ratio of intervention versus usual care dyads (i.e. 18 intervention and 6 control dyads). To ensure adequate numbers of ethnic minority patients in each arm of the trial, we will conduct a stratified randomization such that each arm of the RCT is 50% English language preferring and 50% Spanish language preferring (i.e. 3 in control and 9 in intervention arm). The research assistant will conduct subject assessment at baseline, 1-month, 3-months and 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
depression, family, primary health care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Family-based depression intervention
Arm Type
Experimental
Arm Description
The family-focused component will consist of up to up to 10 joint (i.e. older man alone and/or with family members) sessions that will cover specific topics related to family support of men's depression care provided by a clinic-based social worker
Arm Title
Usual care plus educational materials
Arm Type
Active Comparator
Arm Description
Control subjects will receive usual care in the clinic enhanced by a single depression psychoeducation session.
Intervention Type
Behavioral
Intervention Name(s)
Family-based depression intervention
Intervention Description
The primary focus of our approach is on effectively engaging family members of depressed older men in the care of the patient. The interventionist (social worker) will 1) work jointly with a family member and older men to strengthen depression self-management and participation during primary care visits and 2) conduct a brief training module for primary care provider skills to strengthen their skills in working with family members.
Intervention Type
Behavioral
Intervention Name(s)
Usual care plus educational materials
Intervention Description
Control subjects will receive usual care in the clinic augmented by psychoeducation. Family members will be given standard psychoeducational materials on depression.
Primary Outcome Measure Information:
Title
Depressive Symptoms
Description
Patient Health Questionnaire (PHQ-9) scale; 0-27 scoring units; higher scores indicate more severe depressive symptoms.
Time Frame
baseline, 3 months, and 6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men, age 50 and above
English or Spanish speaking
Score of >9 on the PHQ-9
Non-demented
Have an adult family member or close friend who can participate
Exclusion Criteria:
Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Pregnant women
Prisoners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ladson Hinton, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Joaquin General Hospital
City
Stockton
State/Province
California
ZIP/Postal Code
95231
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Family-based Primary Care Intervention to Enhance Older Men's Depression Care
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