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Group Therapy for Depressed Dementia Caregivers

Mass General Brigham logo

Mass General Brigham

Status

Completed

Conditions

Depression

Treatments

Behavioral: Guided Imagery and Mindfulness
Behavioral: Facilitated Discussion

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03092050
MIT001
R21AG051970 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

46 participants in 2 patient groups

Facilitated Discussion
Active Comparator group
Description:
Weekly facilitated discussion for 4 weeks
Treatment:
Behavioral: Facilitated Discussion
Guided Imagery and mindfulness
Experimental group
Description:
Weekly guided imagery and mindfulness for 4 weeks
Treatment:
Behavioral: Guided Imagery and Mindfulness

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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