Trial Outcomes & Findings for Prevention of Depression in Spouses of People With Cognitive Impairment (NCT NCT00321971)
NCT ID: NCT00321971
Last Updated: 2018-04-03
Results Overview
Depressive symptoms were measured with Center for Epidemiological Studies - Depression Scale (CES-D). The CES-D was designed as a self-report measure of depressive symptoms in nonpsychiatric subjects and has been used with spousal dementia caregiving populations with no report of negative psychological effects. It is composed of 20 items, each rated on a 4-point response scale corresponding to the frequency of the symptom in the preceding week. The possible range of CES-D scores is 0-60, with a higher score indicating more severe symptoms. A cutoff score of 16 or greater is indicative of individuals at high risk for clinical depression. The CES-D was chosen because of its relatively high internal reliability (Cronbach's alpha = .88) and predictive validity for the diagnosis of depression.
COMPLETED
NA
73 participants
Baseline and 1-, 3-, 6-, and 12- months post-treatment
2018-04-03
Participant Flow
The University of Pittsburgh ADRC patient registry was searched for all cases diagnosed with MCI in the 6 months before the start of data collection and new cases of MCI or early dementia (any type) diagnosed at the ADRC during the subsequent 46-month time frame. Participants had to live with the person with MCI or early dementia
Participant milestones
| Measure |
PST-AD/MCI Caregiving
The experimental Intervention focuses on training in adaptive problem-solving attitudes and skills (Problem-Solving Therapy or PST). It sought to enhance problem-solving skill levels of family caregivers as they began to face a variety of potential caregiving stressors. During the first session, participants received written and verbal education about the family caregiving role, the link between problems, overwhelming stress, symptoms of depression or anxiety, and the rationale for problem-solving training. In subsequent sessions, participants received written instructions and coaching in the systematic application of PST. Participants were asked to keep a record of their problem-solving efforts between sessions and questions they had related to the application of PST. These records were used as a basis for discussion during both phases of the intervention.
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NT-MCI/AD Caregiving
The comparison Intervention (Nutritional Training (NT-MCI/AD caregiving) was based on the United States Department of Health and Human Services (USDHHS) "2005 My Pyramid Dietary Guidelines for Americans over Age 50." We chose a nutrition-based comparison intervention because information about dietary practices is not likely to affect mental health outcomes. The NT intervention was matched to the PST-based intervention in terms of number and duration of sessions.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
37
|
|
Overall Study
COMPLETED
|
28
|
26
|
|
Overall Study
NOT COMPLETED
|
8
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevention of Depression in Spouses of People With Cognitive Impairment
Baseline characteristics by cohort
| Measure |
Problem Solving Training (PST)
n=36 Participants
The experimental Intervention focuses on training in adaptive problem-solving attitudes and skills (Problem-Solving Therapy or PST). It sought to enhance problem-solving skill levels of family caregivers as they began to face a variety of potential caregiving stressors. During the first session, participants received written and verbal education about the family caregiving role, the link between problems, overwhelming stress, symptoms of depression or anxiety, and the rationale for problem-solving training. In subsequent sessions, participants received written instructions and coaching in the systematic application of PST. Participants were asked to keep a record of their problem-solving efforts between sessions and questions they had related to the application of PST. These records were used as a basis for discussion during both phases of the intervention.
|
Nutritional Training (NT)
n=37 Participants
The comparison Intervention (Nutritional Training (NT-MCI/AD caregiving) was based on the United States Department of Health and Human Services (USDHHS) "2005 My Pyramid Dietary Guidelines for Americans over Age 50." We chose a nutrition-based comparison intervention because information about dietary practices is not likely to affect mental health outcomes. The NT intervention was matched to the PST-based intervention in terms of number and duration of sessions. Participants were asked to keep a record of menu planning, eating habits between session, and any questions they had related to the application of NT. These records were used as a basis for discussion during both phases of the intervention
|
Total
n=73 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
66.4 Years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
63.4 Years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
64.98 Years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1-, 3-, 6-, and 12- months post-treatmentPopulation: Using an intention-to-treat approach, we performed a repeated-measures linear mixed effects analysis for each study outcome. This analysis included group assignment (PST-MCI/AD Caregiving vs NT), type of caregiver (MCI versus dementia), and time (baseline, 1-, 3-, 6-, and 12-month follow-up). The depression data were log-transformed for analysis.
Depressive symptoms were measured with Center for Epidemiological Studies - Depression Scale (CES-D). The CES-D was designed as a self-report measure of depressive symptoms in nonpsychiatric subjects and has been used with spousal dementia caregiving populations with no report of negative psychological effects. It is composed of 20 items, each rated on a 4-point response scale corresponding to the frequency of the symptom in the preceding week. The possible range of CES-D scores is 0-60, with a higher score indicating more severe symptoms. A cutoff score of 16 or greater is indicative of individuals at high risk for clinical depression. The CES-D was chosen because of its relatively high internal reliability (Cronbach's alpha = .88) and predictive validity for the diagnosis of depression.
Outcome measures
| Measure |
Problem Solving Intervention
n=36 Participants
The experimental Intervention (PST-MCI/AD Caregiving) focuses on training in adaptive problem-solving attitudes and skills (Problem-Solving Therapy or PST). It was adapted from the work of Areán and colleagues, who developed a manualized protocol for PST use in primary care. Our adaptation sought to enhance problem-solving skill levels of family caregivers as they began to face a variety of potential caregiving stressor.
Problem-solving therapy: The self-management intervention will train participants to effectively use problem-solving skills with the aim of strengthening their ability to cope and preventing the onset or worsening of depressive and anxiety disorders. All participants attend weekly individual training sessions, either in their home, another convenient location, or by telephone for a total of 9 weeks.
|
Nutritional Intervention
n=37 Participants
The comparison Intervention (Caregiver Nutritional Training (NT-MCI/AD) was based on the United States Department of Health and Human Services (USDHHS) "2005 My Pyramid Dietary Guidelines for Americans over Age 50." We chose a nutrition-based comparison intervention because information about dietary practices is not likely to affect mental health outcomes. The NT intervention was matched to the PST-based intervention in terms of number and duration of sessions.
Nutritional education program: The nutritional education program will be based on the new USDA dietary recommendations. All participants attend weekly individual training sessions, either in their home or another convenient location for a total of 6 weeks.
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|---|---|---|
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Depressive Symptoms
Baseline
|
9.736 units on a scale
Standard Deviation 1.594
|
11.785 units on a scale
Standard Deviation 1.515
|
|
Depressive Symptoms
1 Month Follow-up
|
8.880 units on a scale
Standard Deviation 1.777
|
12.300 units on a scale
Standard Deviation 1.715
|
|
Depressive Symptoms
3 Month Follow-up
|
8.766 units on a scale
Standard Deviation 1.927
|
13.157 units on a scale
Standard Deviation 1.848
|
|
Depressive Symptoms
6 Month Follow-up
|
6.885 units on a scale
Standard Deviation 1.689
|
13.831 units on a scale
Standard Deviation 1.637
|
|
Depressive Symptoms
12 Month Follow-Up
|
6.475 units on a scale
Standard Deviation 1.619
|
14.143 units on a scale
Standard Deviation 1.571
|
Adverse Events
Experimental Intervention
Comparison/Control Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place