Group Therapy for Depressed Dementia Caregivers

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: Facilitated Discussion; Behavioral: Guided Imagery and Mindfulness

• Registration Number: NCT03092050
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-03-10
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-27
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-01
• Last Update Posted: 2022-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Facilitated Discussion	Facilitated Discussion	Weekly facilitated discussion for 4 weeks
Guided Imagery and mindfulness	Guided Imagery and Mindfulness	Weekly guided imagery and mindfulness for 4 weeks

Primary Outcome Measures

Name	Time	Method
Depression symptoms	approximately 4 weeks post initial group session	Self reported depression symptoms (Quick Inventory of Depression Symptoms)

Secondary Outcome Measures

Name	Time	Method
Depression symptoms - moderate term	approximately 3 months post initial group session	Self reported depression symptoms
Mindfulness	approximately 4 weeks post initial group session and approximately 3 months post initial group session	Five Factor Mindfulness Questionnaire
Positive and Negative Affect	approximately 4 weeks post initial group session and approximately 3 months post initial group session	Positive and Negative Affect Scale
Stress	approximately 4 weeks post initial group session and approximately 3 months post initial group session	Perceived Stress Scale
Well-Being	approximately 4 weeks post initial group session and approximately 3 months post initial group session	Mental Health Continuum Short Form
Depression symptoms - clinician rated	approximately 4 weeks post initial group session and approximately 3 months post initial group session	Hamilton Depression Rating Scale
Resilience	approximately 4 weeks post initial group session and approximately 3 months post initial group session	Connors Davidson Resilience Scale
Connectedness to Nature	approximately 4 weeks post initial group session and approximately 3 months post initial group session	Connectedness to Nature Scale
Caregiver burden	approximately 4 weeks post initial group session and approximately 3 months post initial group session	Caregiver Burden Scale self rated questionnaire
Anxiety symptoms	approximately 4 weeks post initial group session and approximately 3 months post initial group session	State Trait Anxiety Inventory - Trait

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States