Clinical trial NCT00321971: Prevention of Depression in Spouses of People With Cognitive Impairment
Official title: Prevention of Psychiatric Morbidity in AD Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Anxiety
Mild Cognitive Impairment
MCI
Cognitive Impairment
Alzheimer's Disease
Caregiver Burden
Caregiver Stress
Family Dementia Caregiving
Spousal Dementia Caregiving
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-05-04
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 participant's spouse is diagnosed with dementia during the study, additional follow-up data is collected after the Month 12 visit.

Eligibility criteria: 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

Primary outcomes:
measure: Depressive Symptoms
timeFrame: Baseline and 1-, 3-, 6-, and 12- months post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Alzheimer's Disease Research Center (ADRC)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Duquesne Univeristy
state: Pennsylvania
Study officials:
affiliation: The University of Pittsburgh School of Nursing
name: Linda J. Garand, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garand L, Dew MA, Eazor LR, DeKosky ST, Reynolds CF 3rd. Caregiving burden and psychiatric morbidity in spouses of persons with mild cognitive impairment. Int J Geriatr Psychiatry. 2005 Jun;20(6):512-22. doi: 10.1002/gps.1318.
citation: Garand L, Rinaldo DE, Alberth MM, Delany J, Beasock SL, Lopez OL, Reynolds CF 3rd, Dew MA. Effects of problem solving therapy on mental health outcomes in family caregivers of persons with a new diagnosis of mild cognitive impairment or early dementia: a randomized controlled trial. Am J Geriatr Psychiatry. 2014 Aug;22(8):771-81. doi: 10.1016/j.jagp.2013.07.007. Epub 2013 Oct 8.
citation: Garand L, Morse JQ, ChiaRebecca L, Barnes J, Dadebo V, Lopez OL, Dew MA. Problem-solving therapy reduces subjective burden levels in caregivers of family members with mild cognitive impairment or early-stage dementia: Secondary analysis of a randomized clinical trial. Int J Geriatr Psychiatry. 2019 Jul;34(7):957-965. doi: 10.1002/gps.5095. Epub 2019 Apr 17.