Prevention of Depression in Spouses of People With Cognitive Impairment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00321971
First received: May 2, 2006
Last updated: March 25, 2009
Last verified: March 2009
  Purpose

This study evaluates the effectiveness of a problem-solving training program in preventing depression in the spouses or family caregivers of persons with mild cognitive impairment or early dementia.


Condition Intervention Phase
Depression
Behavioral: Problem-solving therapy
Behavioral: Nutritional education program
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Psychiatric Morbidity in AD Caregivers

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Depressive symptoms [ Time Frame: Measured at baseline and Months 1, 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Anxiety symptoms [ Time Frame: Measured at baseline and Months 1, 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective caregiver burden [ Time Frame: Measured at baseline and Months 1, 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Subjective caregiver burden [ Time Frame: Measured at baseline and Months 1, 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Household management and care giving responsibilities [ Time Frame: Measured at baseline and Months 1, 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Coping abilities [ Time Frame: Measured at baseline and Months 1, 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Quality of the marital relationship [ Time Frame: Measured at baseline and Months 1, 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Social support [ Time Frame: Measured at baseline and Months 1, 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Anticipatory grief [ Time Frame: Measured at baseline and Months 1, 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Social problem solving abilities [ Time Frame: Measured at baseline and Months 1, 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Measured at baseline and Months 1, 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2007
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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, another convenient location, or by telephone for a total of 9 weeks.
Active Comparator: 2
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 trains participants to effectively use problem-solving skills with the aim of strengthening their ability to cope with burdens of caregiving and preventing the onset or worsening of depressive and anxiety disorders. The nutritional education program is 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. At the end of 6 weeks, participants receive a weekly phone call for an additional 3 weeks to support the training they received. Follow-up data is collected at Months 1, 3, 6, and 12 post-intervention. If a participant's spouse is diagnosed with dementia during the study, additional follow-up data is collected 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Linda Garand, Assistant Professor, University of Pittsburgh School of Nursing
ClinicalTrials.gov Identifier: NCT00321971     History of Changes
Other Study ID Numbers: K23 MH070719, DATR AK-TNAI1
Study First Received: May 2, 2006
Last Updated: March 25, 2009
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
Caregiver Burden
Caregiver Stress
Family Dementia Caregiving
Spousal Dementia Caregiving

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014