Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321971
Status:
COMPLETED
Last Update Posted:
2018-04-03
First Post:
2006-05-02
Brief Title:
Prevention of Depression in Spouses of People With Cognitive Impairment
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Prevention of Psychiatric Morbidity in AD Caregivers
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 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 participants spouse is diagnosed with dementia during the study additional follow-up data is collected after the Month 12 visit
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 participants spouse is diagnosed with dementia during the study additional follow-up data is collected after the Month 12 visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23MH070719 | NIH | None | httpsreporternihgovquickSearchK23MH070719 |