An interventional study of Guided Imagery and Mindfulness and Facilitated Discussion in Depression, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2022-09-06.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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.
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.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's enrollment of 46 is below the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Weekly facilitated discussion for 4 weeks
Behavioral: Facilitated Discussion
Weekly guided imagery and mindfulness for 4 weeks
Behavioral: Guided Imagery and Mindfulness
This is a behavioral intervention using guided imagery and mindfulness techniques.
This is a behavioral intervention that involves discussion and group support.
Depression symptoms
Self reported depression symptoms (Quick Inventory of Depression Symptoms)
Time frame: approximately 4 weeks post initial group session
Depression symptoms - moderate term
Self reported depression symptoms
Time frame: approximately 3 months post initial group session
Depression symptoms - clinician rated
Hamilton Depression Rating Scale
Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Caregiver burden
Caregiver Burden Scale self rated questionnaire
Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Anxiety symptoms
State Trait Anxiety Inventory - Trait
Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Mindfulness
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
Positive and Negative Affect Scale
Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Well-Being
Mental Health Continuum Short Form
Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Stress
Perceived Stress Scale
Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Resilience
Connors Davidson Resilience Scale
Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Connectedness to Nature
Connectedness to Nature Scale
Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital