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Prevention of Depression in Spouses of People With Cognitive Impairment

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ClinicalTrials.gov Identifier: NCT00321971
Recruitment Status : Completed
First Posted : May 4, 2006
Results First Posted : March 7, 2018
Last Update Posted : April 3, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Linda Garand, Duquesne University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Depression
Interventions Behavioral: PST-MCI/AD Caregiving
Behavioral: NT-MCI/AD Caregiving
Enrollment 73

Recruitment Details 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
Pre-assignment Details  
Arm/Group Title PST-AD/MCI Caregiving NT-MCI/AD Caregiving
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 36 [1] 37
Completed 28 26
Not Completed 8 11
[1]
Subject recruitment began in February 2007 and ended in December 2011
Arm/Group Title Problem Solving Training (PST) Nutritional Training (NT) Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 36 37 73
Hide Baseline Analysis Population Description
Of the 73 subjects enrolled in the study, 54 (71%) completed the study. Using an intention-to- treat approach, we performed a repeated-measures linear mixed effects analysis with the total sample (N=73) .
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 37 participants 73 participants
66.4  (8.0) 63.4  (13.7) 64.98  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 37 participants 73 participants
Female
28
  77.8%
29
  78.4%
57
  78.1%
Male
8
  22.2%
8
  21.6%
16
  21.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 37 participants 73 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
36
 100.0%
37
 100.0%
73
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 37 participants 73 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   2.8%
0
   0.0%
1
   1.4%
White
35
  97.2%
37
 100.0%
72
  98.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 36 participants 37 participants 73 participants
36
 100.0%
37
 100.0%
73
 100.0%
1.Primary Outcome
Title Depressive Symptoms
Hide Description 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.
Time Frame Baseline and 1-, 3-, 6-, and 12- months post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Problem Solving Intervention Nutritional Intervention
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 36 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 9.736  (1.594) 11.785  (1.515)
1 Month Follow-up 8.880  (1.777) 12.300  (1.715)
3 Month Follow-up 8.766  (1.927) 13.157  (1.848)
6 Month Follow-up 6.885  (1.689) 13.831  (1.637)
12 Month Follow-Up 6.475  (1.619) 14.143  (1.571)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Problem Solving Intervention
Comments Hypothesis: The experimental intervention group will endorse lower mean levels of depressive symptoms during follow-up than the study group receiving the comparison intervention.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments Intention-to-treat model
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.421
Confidence Interval (2-Sided) 95%
0.208 to 0.657
Parameter Dispersion
Type: Standard Error of the Mean
Value: .110
Estimation Comments The CES-D data were log-transformed for analysis
Time Frame Baseline, 1, 3, 6 and 12 months post intervention
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental Intervention Comparison/Control Intervention
Hide Arm/Group Description

The experimental Intervention (PST-MCI/AD Caregiving) focuses on training in adaptive problem-solving attitudes and skills (Problem-Solving Therapy or PST). Participants received 2 phases of treatment; the first phase involved 6 sessions conducted in the caregiver’s home approximately 2 weeks apart, each lasting approximately 1.5 hours. The second phase included three telephone contacts (approximately 2 weeks apart) to reinforce principles taught during the first phase, each lasting approximately 45 minutes.

During the first session, participants received written and verbal education about the structure of sessions, MCI or dementia and the family caregiving role, the link between problems, overwhelming stress, and symptoms of depression, the relationship between low mood and reduced pleasurable activities, and the rationale for problem-solving training. In subsequent sessions, participants received written instructions and coaching in the systematic application of PST.

The comparison Intervention (Caregiver Nutritional Training (NT-MCI/AD) was based on the USDHHS "My Pyramid Dietary Guidelines for Americans over Age 50." The NT intervention was matched to the PST-based intervention in terms of number and duration of sessions.

During the first session, participants received written and verbal education about the structure of the sessions, MCI or dementia, and an overview of USDA Dietary Guidelines. Participants also completed a questionnaire about their current eating practices and activity level. In subsequent training sessions, the interventionist provided education related to the major food categories, discretionary calories, and tips and resources for menu planning. 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.

All-Cause Mortality
Experimental Intervention Comparison/Control Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Experimental Intervention Comparison/Control Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/37 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experimental Intervention Comparison/Control Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/37 (0.00%) 
The relatively small size and racial composition of the sample was a limitation. The generalizability of our findings are reduced by our focus on family caregivers who reside with the individual with cognitive impairment.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Linda Garand PhD
Organization: Duquesne University School of Nursing
Phone: 412-396-6543
Responsible Party: Linda Garand, Duquesne University
ClinicalTrials.gov Identifier: NCT00321971     History of Changes
Other Study ID Numbers: K23MH070719 ( U.S. NIH Grant/Contract )
K23MH070719 ( U.S. NIH Grant/Contract )
First Submitted: May 2, 2006
First Posted: May 4, 2006
Results First Submitted: February 12, 2014
Results First Posted: March 7, 2018
Last Update Posted: April 3, 2018