A Family-based Primary Care Intervention to Enhance Older Men's Depression Care

Major Depression Clinical Trial

Official title:

A Family-based Primary Care Intervention to Enhance Older Men's Depression Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02143024
• Other study ID #: 807849
• Status: Completed
• Phase: N/A
• Start date: November 1, 2015
• Est. completion date: December 31, 2016

Study information

• Verified date: January 2020
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Major Depression

Intervention

Behavioral:
• Family-based depression intervention
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.
• Usual care plus educational materials
Control subjects will receive usual care in the clinic augmented by psychoeducation. Family members will be given standard psychoeducational materials on depression.

Locations

Country	Name	City	State
United States	San Joaquin General Hospital	Stockton	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Davis	RAND, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive Symptoms	Patient Health Questionnaire (PHQ-9) scale; 0-27 scoring units; higher scores indicate more severe depressive symptoms.	baseline, 3 months, and 6 months