ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevention of Depression in Spouses of People With Cognitive Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

May 2, 2006
May 4, 2006
February 12, 2014
March 7, 2018
April 3, 2018
February 2007
December 2011   (Final data collection date for primary outcome measure)
Depressive Symptoms [ Time Frame: Baseline and 1-, 3-, 6-, and 12- months post-treatment ]
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.
  • 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
Not Provided
  • 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 depression. The nutritional education program is based on the new United States Department of Health and Human Services 2005 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
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Depression
  • Behavioral: PST-MCI/AD Caregiving
    The PST-based 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. 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.
  • Behavioral: NT-MCI/AD Caregiving
    The nutritional education program will be based on the new USSDA dietary recommendations. 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.
  • Experimental: PST-MCI/AD Caregiving
    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 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.
    Intervention: Behavioral: PST-MCI/AD Caregiving
  • Active Comparator: NT-MCI/AD Caregiving
    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.
    Intervention: Behavioral: NT-MCI/AD Caregiving

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
165
December 2011
December 2011   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00321971
K23MH070719( U.S. NIH Grant/Contract )
K23MH070719 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Linda Garand, Duquesne University
University of Pittsburgh
National Institute of Mental Health (NIMH)
Principal Investigator: Linda J. Garand, PhD The University of Pittsburgh School of Nursing
University of Pittsburgh
March 2018

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