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Prevention of Depression in Spouses of People With Cognitive Impairment

This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), December 2007

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00321971
  Purpose

This study evaluates the effectiveness of a problem-solving training program in preventing depression in the spouses or significant others of people with mild cognitive impairment.


Condition Intervention Phase
Depression
Behavioral: Problem-solving therapy
Behavioral: Nutritional education program
Phase I

MedlinePlus related topics:   Depression  

ChemIDplus related topics:   Attapulgite   Bismuth subsalicylate   Kaopectate  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Prevention of Psychiatric Morbidity in AD Caregivers

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Depressive symptoms [ Time Frame: Measured at baseline and Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Anxiety symptoms [ Time Frame: Measured at baseline and Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective caregiver burden [ Time Frame: Measured at baseline and Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Subjective caregiver burden [ Time Frame: Measured at baseline and Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Household management and care giving responsibilities [ Time Frame: Measured at baseline and Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Coping abilities [ Time Frame: Measured at baseline and Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Quality of the marital relationship [ Time Frame: Measured at baseline and Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Social support [ Time Frame: Measured at baseline and Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Anticipatory grief [ Time Frame: Measured at baseline and Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Social problem solving abilities [ Time Frame: Measured at baseline and Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Measured at baseline and Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:   165
Study Start Date:   February 2007
Estimated Study Completion Date:   April 2011
Estimated Primary Completion Date:   January 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Participants assigned to receive self-management intervention targeted at problem-solving training
Behavioral: 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 or another convenient location for a total of 6 weeks.
2: Active Comparator
Participants assigned to receive attention-matched intervention targeted at nutritional education
Behavioral: 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.

Detailed Description:

People with a diagnosis of mild cognitive impairment (MCI) have an estimated 12% probability each year of progressing to a dementing disorder. Pilot data suggest that the spouses of people with MCI begin to adopt the caregiver role and its burdens as they cope with this condition. Although levels of caregiver burden and psychiatric illness are lower than those typically observed in family dementia caregiving samples, our findings suggest that MCI spousal caregivers have already begun to experience distress associated with elevated caregiver burden. In order to protect the mental health and well-being of caregivers as they cope with their spouses' current and future health care needs, it may be ideal to implement selective preventive strategies while they are in the very earliest stages of caregiving. This study evaluates the effectiveness of a problem-solving training program in preventing depression in the spouses or significant others of people with MCI.

Participants in this open-label study are randomly assigned to receive either a self-management intervention targeted at problem-solving training or an attention-matched intervention targeted at nutritional education. 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. 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. These visits will include training, interviews, and assessments. At the end of 6 weeks, participants will receive a weekly phone call for an additional 6 weeks to support the training they received. Follow-up visits will be held at Months 1, 3, 6, and 12 post-intervention. If a participant's spouse is diagnosed with dementia during the study, an additional follow-up visit will be held after the Month 12 visit.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Spouse or non-married partner of a patient being treated at the University of Pittsburgh Alzheimer's Disease Research Center (ADRC) for a new or subsequent diagnosis of MCI

Exclusion Criteria:

  • Does not speak English
  • Cohabitating adult child of a person with MCI
  • Resides in an institutional or assisted-living setting
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321971

Contacts
Contact: Linda J. Garand, PhD     412-383-7946     ligst4@pitt.edu    

Locations
United States, Pennsylvania
University of Pittsburgh Alzheimer's Disease Research Center (ADRC)     Recruiting
      Pittsburgh, Pennsylvania, United States, 15213
      Principal Investigator: Linda J. Garand, PhD            

Sponsors and Collaborators

Investigators
Principal Investigator:     Linda J. Garand, PhD     The University of Pittsburgh School of Nursing    
  More Information

Publications:

Responsible Party:   University of Pittsburgh School of Nursing ( Linda Garand, Assistant Professor )
Study ID Numbers:   K23 MH70719, DATR AK-TNAI1
First Received:   May 2, 2006
Last Updated:   December 26, 2007
ClinicalTrials.gov Identifier:   NCT00321971
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Anxiety  
Mild Cognitive Impairment  
MCI  
Cognitive Impairment  
Alzheimer's Disease  
Care Giving Burden
Care Giving Stress
Family Dementia Care Giving
Spousal Dementia Care Giving
Problem Solving

Study placed in the following topic categories:
Attapulgite
Depression
Alzheimer Disease
Mood Disorders
Stress
Depressive Disorder
Dementia
Bismuth subsalicylate

Additional relevant MeSH terms:
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 15, 2008