Trial Outcomes & Findings for A Family-based Primary Care Intervention to Enhance Older Men's Depression Care (NCT NCT02143024)
NCT ID: NCT02143024
Last Updated: 2020-01-18
Results Overview
Patient Health Questionnaire (PHQ-9) scale; 0-27 scoring units; higher scores indicate more severe depressive symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
baseline, 3 months, and 6 months
Results posted on
2020-01-18
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
8
|
|
Overall Study
Received Treatment
|
13
|
7
|
|
Overall Study
COMPLETED
|
13
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Family-based Primary Care Intervention to Enhance Older Men's Depression Care
Baseline characteristics by cohort
| Measure |
Family-based Depression Intervention
n=13 Participants
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.
|
Usual Care Plus Educational Materials
n=7 Participants
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.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
57.4 years
STANDARD_DEVIATION 4.8 • n=7 Participants
|
59.2 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American and White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
7 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 3 months, and 6 monthsPatient Health Questionnaire (PHQ-9) scale; 0-27 scoring units; higher scores indicate more severe depressive symptoms.
Outcome measures
| Measure |
Family-based Depression Intervention
n=13 Participants
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.
|
Usual Care Plus Educational Materials
n=7 Participants
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.
|
|---|---|---|
|
Depressive Symptoms
6 months
|
11.8 units on a scale
Standard Deviation 7.1
|
13.3 units on a scale
Standard Deviation 6.3
|
|
Depressive Symptoms
baseline
|
14.8 units on a scale
Standard Deviation 2.9
|
15.3 units on a scale
Standard Deviation 4.1
|
|
Depressive Symptoms
3 months
|
10.1 units on a scale
Standard Deviation 6.6
|
13.0 units on a scale
Standard Deviation 7.5
|
Adverse Events
Family-based Depression Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care Plus Educational Materials
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ladson Hinton, MD
UC Davis Department of Psychiatry and Behavioral Sciences
Phone: (916) 734-3485
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place