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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.
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.

Participant Flow:   Overall Study
    PST-AD/MCI Caregiving   NT-MCI/AD Caregiving
STARTED   36 [1]   37 
COMPLETED   28   26 
NOT COMPLETED   8   11 
[1] Subject recruitment began in February 2007 and ended in December 2011



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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) .

Reporting Groups
  Description
Problem Solving Training (PST) 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) 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 Total of all reporting groups

Baseline Measures
   Problem Solving Training (PST)   Nutritional Training (NT)   Total 
Overall Participants Analyzed 
[Units: Participants]
 36   37   73 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.4  (8.0)   63.4  (13.7)   64.98  (11.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      28  77.8%      29  78.4%      57  78.1% 
Male      8  22.2%      8  21.6%      16  21.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
United States   36   37   73 


  Outcome Measures

1.  Primary:   Depressive Symptoms   [ Time Frame: Baseline and 1-, 3-, 6-, and 12- months post-treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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
e-mail: garandl@duq.edu


Publications of Results:
Other Publications:

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