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Trial record 93 of 1270 for:    depression AND Major Depression AND depressive symptoms | "Depression"

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

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ClinicalTrials.gov Identifier: NCT02143024
Recruitment Status : Completed
First Posted : May 20, 2014
Last Update Posted : April 5, 2017
Sponsor:
Collaborators:
University of Washington
RAND
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Major Depression Behavioral: Family-based depression intervention Behavioral: Usual care plus educational materials Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Family-based Primary Care Intervention to Enhance Older Men's Depression Care
Actual Study Start Date : November 1, 2015
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
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.

Active Comparator: Usual care plus educational materials
Control subjects will receive usual care in the clinic enhanced by a single depression psychoeducation session.
Behavioral: 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.




Primary Outcome Measures :
  1. Depressive symptoms [ Time Frame: up to 6 months ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • men, age 60 and above, English or Spanish speaking, significant depressive symptoms (i.e. PHQ > 15, have at least one criteria A symptom (depressed mood or anhedonia), depression-related functional impairment, have an adult family member willing to participate in the study

Exclusion Criteria:

  • psychotic, demented, institutionalized

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143024


Locations
United States, California
San Joaquin General Hospital
Stockton, California, United States, 95231
Sponsors and Collaborators
University of California, Davis
University of Washington
RAND
Investigators
Principal Investigator: Ladson Hinton, MD University of California, Davis

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02143024     History of Changes
Other Study ID Numbers: 807849
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of California, Davis:
depression
family
primary health care

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders