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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

May 2, 2006
March 25, 2009
February 2007
April 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • Measured at Month 6 and 12 months post-intervention: Depressive symptoms
  • Anxiety symptoms
  • Social problem-solving abilities
Complete list of historical versions of study NCT00321971 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Measured at Month 6 and 12 months post-intervention: Objective caregiver burden
  • Subjective caregiver burden
  • Household management and care giving responsibilities
  • Stress related to MCI behavior
  • Coping abilities
  • Quality of the marital relationship
  • Social support
Not Provided
Not Provided
 
Prevention of Depression in Spouses of People With Cognitive Impairment
Prevention of Psychiatric Morbidity in AD Caregivers

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Depression
  • 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.
  • 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.
  • Experimental: 1
    Participants assigned to receive self-management intervention targeted at problem-solving training
    Intervention: Behavioral: Problem-solving therapy
  • Active Comparator: 2
    Participants assigned to receive attention-matched intervention targeted at nutritional education
    Intervention: Behavioral: Nutritional education program

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Linda J. Garand, PhD 412-383-7946 ligst4@pitt.edu
United States
 
NCT00321971
K23 MH070719, DATR AK-TNAI1
Yes
Linda Garand, Assistant Professor, University of Pittsburgh School of Nursing
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Linda J. Garand, PhD The University of Pittsburgh School of Nursing
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP