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Completed

NCT Number: NCT02143024

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

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.

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Key information

Conditions

Major Depression Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

San Joaquin General Hospital

Stockton, California, 95231, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Family-based depression intervention

Behavioral

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

Behavioral

Control subjects will receive usual care in the clinic augmented by psychoeducation. Family members will be given standard psychoeducational materials on depression.

Primary outcomes

  1. Depressive Symptoms

    Time frame: baseline, 3 months, and 6 months

    Patient Health Questionnaire (PHQ-9) scale; 0-27 scoring units; higher scores indicate more severe depressive symptoms.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • RAND
  • University of Washington

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 20, 2014
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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