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| Descriptive Information Fields | |||||
| Brief Title † | Prevention of Depression in Spouses of People With Cognitive Impairment | ||||
| Official Title † | Prevention of Psychiatric Morbidity in AD Caregivers | ||||
| Brief Summary | This study evaluates the effectiveness of a problem-solving training program in preventing depression in the spouses or significant others of people with mild cognitive impairment. |
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| 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 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. 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. These visits will include training, interviews, and assessments. At the end of 6 weeks, participants will receive a weekly phone call for an additional 6 weeks to support the training they received. Follow-up visits will be held at Months 1, 3, 6, and 12 post-intervention. If a participant's spouse is diagnosed with dementia during the study, an additional follow-up visit will be held after the Month 12 visit. |
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| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Depressive symptoms [ Time Frame: Measured at baseline and Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ] Anxiety symptoms [ Time Frame: Measured at baseline and Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Objective caregiver burden [ Time Frame: Measured at baseline and Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ] Subjective caregiver burden [ Time Frame: Measured at baseline and Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ] Household management and care giving responsibilities [ Time Frame: Measured at baseline and Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ] Coping abilities [ Time Frame: Measured at baseline and Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ] Quality of the marital relationship [ Time Frame: Measured at baseline and Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ] Social support [ Time Frame: Measured at baseline and Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ] Anticipatory grief [ Time Frame: Measured at baseline and Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ] Social problem solving abilities [ Time Frame: Measured at baseline and Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ] Quality of Life [ Time Frame: Measured at baseline and Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ] |
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| Condition † | Depression | ||||
| Intervention † | Behavioral: Problem-solving therapy Behavioral: Nutritional education program |
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| MEDLINE PMIDs | 15920711 | ||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 165 | ||||
| Start Date † | February 2007 | ||||
| Completion Date | April 2011 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00321971 | ||||
| Organization ID | K23 MH70719 | ||||
| Secondary IDs †† | DATR AK-TNAI1 | ||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | December 2007 | ||||
| First Received Date † | May 2, 2006 | ||||
| Last Updated Date | December 26, 2007 | ||||
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