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

NCT02143024 | Completed Results

• 1 other identifier: 807849
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression

Keywords

depression; family; primary health care

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Family-based depression intervention

EXPERIMENTAL

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

Behavioral: Family-based depression intervention

Usual care plus educational materials

ACTIVE COMPARATOR

Control subjects will receive usual care in the clinic enhanced by a single depression psychoeducation session.

Behavioral: Usual care plus educational materials

Interventions

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.

Family-based depression intervention

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.

Usual care plus educational materials

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners

Sponsors & Collaborators

• University of California, Davis: lead
• University of Washington: collaborator
• RAND: collaborator

Study Sites (1)

San Joaquin General Hospital

Stockton, California, 95231, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Ladson Hinton, MD
• Organization: UC Davis Department of Psychiatry and Behavioral Sciences

lwhinton@ucdavis.edu

(916) 734-3485

Study Officials

• Ladson Hinton, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: May 20, 2014
• Study Start: November 1, 2015
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: January 18, 2020
• Results First Posted: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)