Prevention of Depression in Spouses of People With Cognitive Impairment
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Behavioral: Problem-solving therapy Behavioral: Nutritional education program |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Prevention of Psychiatric Morbidity in AD Caregivers |
- 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 ]
- 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 ]
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | April 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants assigned to receive self-management intervention targeted at problem-solving training
|
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.
|
|
Active Comparator: 2
Participants assigned to receive attention-matched intervention targeted at nutritional education
|
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.
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Linda J. Garand, PhD | 412-383-7946 | ligst4@pitt.edu |
| United States, Pennsylvania | |
| University of Pittsburgh Alzheimer's Disease Research Center (ADRC) | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: Linda J. Garand, PhD | |
| Principal Investigator: | Linda J. Garand, PhD | The University of Pittsburgh School of Nursing |
More Information
Publications:
| Responsible Party: | Linda Garand, Assistant Professor, University of Pittsburgh School of Nursing |
| ClinicalTrials.gov Identifier: | NCT00321971 History of Changes |
| Other Study ID Numbers: | K23 MH070719, DATR AK-TNAI1 |
| Study First Received: | May 2, 2006 |
| Last Updated: | March 25, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Anxiety Mild Cognitive Impairment MCI Cognitive Impairment Alzheimer's Disease |
Caregiver Burden Caregiver Stress Family Dementia Caregiving Spousal Dementia Caregiving |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013