Group Therapy for Depressed Dementia Caregivers

Group Therapy for Depressed Caregivers of Alzheimer's Disorder and Related Dementias

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Facilitated Discussion; Behavioral: Guided Imagery and Mindfulness

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Facilitated Discussion; Weekly facilitated discussion for 4 weeks	Behavioral: Facilitated Discussion; This is a behavioral intervention that involves discussion and group support.
Experimental: Guided Imagery and mindfulness; Weekly guided imagery and mindfulness for 4 weeks	Behavioral: Guided Imagery and Mindfulness; This is a behavioral intervention using guided imagery and mindfulness techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression symptoms	Self reported depression symptoms (Quick Inventory of Depression Symptoms)	approximately 4 weeks post initial group session

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Felipe Jain, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (Actual): March 27, 2017

Study Record Updates

• Last Update Posted (Actual): September 6, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: MIT001; R21AG051970 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No