Prevention of Depression in Spouses of People With Cognitive Impairment

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00321971
Study type	Interventional
Source	University of Pittsburgh
Contact
Status	Completed
Phase	N/A
Start date	February 2007
Completion date	December 2011

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.