Major Depression
Conditions
Keywords
depression, family, primary health care
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.
Interventions
BEHAVIORALFamily-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.
BEHAVIORALUsual 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.
Sponsors
University of Washington
RAND
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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
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. | 13 |
| Usual Care Plus Educational Materials Control subjects will receive usual care in the clinic enhanced by a single depression psychoeducation session.
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. | 7 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Family-based Depression Intervention | Usual Care Plus Educational Materials | Total |
|---|---|---|---|
| Age, Continuous | 60.2 years STANDARD_DEVIATION 9.6 | 57.4 years STANDARD_DEVIATION 4.8 | 59.2 years STANDARD_DEVIATION 8.1 |
| Race/Ethnicity, Customized African American | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic | 10 Participants | 2 Participants | 12 Participants |
| Race/Ethnicity, Customized Native American and White | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 13 participants | 7 participants | 20 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 13 Participants | 7 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 7 |
| other Total, other adverse events | 0 / 13 | 0 / 7 |
| serious Total, serious adverse events | 0 / 13 | 0 / 7 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Family-based Depression Intervention | Depressive Symptoms | 6 months | 11.8 units on a scale | Standard Deviation 7.1 |
| Family-based Depression Intervention | Depressive Symptoms | baseline | 14.8 units on a scale | Standard Deviation 2.9 |
| Family-based Depression Intervention | Depressive Symptoms | 3 months | 10.1 units on a scale | Standard Deviation 6.6 |
| Usual Care Plus Educational Materials | Depressive Symptoms | 3 months | 13.0 units on a scale | Standard Deviation 7.5 |
| Usual Care Plus Educational Materials | Depressive Symptoms | baseline | 15.3 units on a scale | Standard Deviation 4.1 |
| Usual Care Plus Educational Materials | Depressive Symptoms | 6 months | 13.3 units on a scale | Standard Deviation 6.3 |