An interventional study of Family-based depression intervention and Usual care plus educational materials in Major Depression, sponsored by University of California, Davis. Completed at 1 site in United States. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by University of California, Davis · Not applicable, Interventional, and Treatment
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 23 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.
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Exclusion Criteria:
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
Control subjects will receive usual care in the clinic enhanced by a single depression psychoeducation session.
Behavioral: Usual care plus educational materials
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.
Control subjects will receive usual care in the clinic augmented by psychoeducation. Family members will be given standard psychoeducational materials on depression.
Depressive Symptoms
Patient Health Questionnaire (PHQ-9) scale; 0-27 scoring units; higher scores indicate more severe depressive symptoms.
Time frame: baseline, 3 months, and 6 months
45 people were referred to the study. 41 people were assessed, 4 were not assessed for eligibility. 18 were excluded; 10 did not meet inclusion criteria and 8 declined. A total of 23 people were randomized as part of the study.
| Milestone | Family-based Depression Intervention | Usual Care Plus Educational Materials |
|---|---|---|
| Started | 15 | 8 |
| Received treatment | 13 | 7 |
| Completed | 13 | 7 |
| Not completed | 2 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
Patient Health Questionnaire (PHQ-9) scale; 0-27 scoring units; higher scores indicate more severe depressive symptoms.
| units on a scale | Family-based Depression Intervention | Usual Care Plus Educational Materials |
|---|---|---|
| baseline | 14.8 ± 2.9 | 15.3 ± 4.1 |
| 3 months | 10.1 ± 6.6 | 13.0 ± 7.5 |
| 6 months | 11.8 ± 7.1 | 13.3 ± 6.3 |
Collected over Adverse events were monitored up until the 6 month visit.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Family-based Depression Intervention | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Usual Care Plus Educational Materials | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
Randomized participants that received at least 1 session.
| Age, Continuous(years) | Family-based Depression Intervention | Usual Care Plus Educational Materials | Total |
|---|---|---|---|
| Mean | 60.2 ± 9.6 | 57.4 ± 4.8 | 59.2 ± 8.1 |
| Sex: Female, Male(Participants) | Family-based Depression Intervention | Usual Care Plus Educational Materials | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 13 | 7 | 20 |
| Race/Ethnicity, Customized(Participants) | Family-based Depression Intervention | Usual Care Plus Educational Materials | Total |
|---|---|---|---|
| Hispanic | 10 | 2 | 12 |
| African American | 1 | 3 | 4 |
| White | 1 | 1 | 2 |
| Native American and White | 1 | 1 | 2 |
| Region of Enrollment(participants) | Family-based Depression Intervention | Usual Care Plus Educational Materials | Total |
|---|---|---|---|
| United States | 13 | 7 | 20 |
Plan to share: No
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University of California, Davis