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

Not Applicable

Completed

Conditions: Major Depression

Interventions: Behavioral: Usual care plus educational materials
Behavioral: Family-based depression intervention

Registration Number: NCT02143024

Lead Sponsor: University of California, Davis

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 23

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care plus educational materials	Usual care plus educational materials	Control subjects will receive usual care in the clinic enhanced by a single depression psychoeducation session.
Family-based depression intervention	Family-based depression intervention	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

Primary Outcome Measures

Name	Time	Method
Depressive Symptoms	baseline, 3 months, and 6 months	Patient Health Questionnaire (PHQ-9) scale; 0-27 scoring units; higher scores indicate more severe depressive symptoms.

Secondary Outcome Measures