Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT03092050
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.
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Notify Me45 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02114, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
This is a behavioral intervention using guided imagery and mindfulness techniques.
This is a behavioral intervention that involves discussion and group support.
Time frame: approximately 4 weeks post initial group session
Self reported depression symptoms (Quick Inventory of Depression Symptoms)
Time frame: approximately 3 months post initial group session
Self reported depression symptoms
Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Hamilton Depression Rating Scale
Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Caregiver Burden Scale self rated questionnaire
Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
State Trait Anxiety Inventory - Trait
Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Five Factor Mindfulness Questionnaire
Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Positive and Negative Affect Scale
Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Mental Health Continuum Short Form
Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Perceived Stress Scale
Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Connors Davidson Resilience Scale
Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Connectedness to Nature Scale
Massachusetts General Hospital
Other
Group Therapy for Depressed Caregivers of Alzheimer's Disorder and Related Dementias
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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