Group Therapy for Depressed Caregivers of Alzheimer's Disorder and Related Dementias
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Depression symptoms
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Depression in family caregivers of relatives with Alzheimer's Disorder and related dementias is a serious public health problem. This is a randomized, controlled, single-blind pilot clinical trial of depressed caregivers, to determine the efficacy and mechanisms of group therapy for depressed dementia caregivers.
Detailed Description
The trial was designed to measure clinical outcomes including depressive symptoms and other secondary outcomes of caregivers of persons living with dementia. It also included magnetic resonance imagery scanning at baseline (prior to study group) and post group to identify candidate mechanisms of effects. Notes related to outcome measurement. On 05.10.2017 (prior to participant enrollment), all secondary outcomes were approved by the UCSF IRB #16-20163. It was noted in the IRB that the primary outcome timepoint was to be obtained 4 weeks after the first group session. Due to magnetic resonance imaging scanning scheduling constraints, which occurred at the same time as the 4 weeks visit, the outcome could not be exactly four weeks post the first group session but was collected approximately at this time. On 05.10.2017 (prior to participant enrollment), three-month post group secondary outcomes were also approved.
Investigators
Felipe A Jain
Psychiatrist
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •Endorse clinically relevant baseline depressive symptoms Primary caregiver for a relative with dementia
Exclusion Criteria
- •Age \< 45 Meditation / guided imagery practice more than twice per week Ideas of harming relative with dementia Current violence towards relative with dementia Adult Protective Services report on file Primary psychiatric disorder other than unipolar major depression Cognitive impairment on the part of the caregiver (Mini Mental State Examination score less than 24) Unstable medical illness Planned surgery Active drug or alcohol abuse Inability to understand written and oral English.
Outcomes
Primary Outcomes
Depression symptoms
Time Frame: approximately 4 weeks post initial group session
Self reported depression symptoms (Quick Inventory of Depression Symptoms)
Secondary Outcomes
- Depression symptoms - moderate term(approximately 3 months post initial group session)
- Mindfulness(approximately 4 weeks post initial group session and approximately 3 months post initial group session)
- Positive and Negative Affect(approximately 4 weeks post initial group session and approximately 3 months post initial group session)
- Stress(approximately 4 weeks post initial group session and approximately 3 months post initial group session)
- Well-Being(approximately 4 weeks post initial group session and approximately 3 months post initial group session)
- Depression symptoms - clinician rated(approximately 4 weeks post initial group session and approximately 3 months post initial group session)
- Resilience(approximately 4 weeks post initial group session and approximately 3 months post initial group session)
- Connectedness to Nature(approximately 4 weeks post initial group session and approximately 3 months post initial group session)
- Caregiver burden(approximately 4 weeks post initial group session and approximately 3 months post initial group session)
- Anxiety symptoms(approximately 4 weeks post initial group session and approximately 3 months post initial group session)