Group Therapy for Depressed Dementia Caregivers

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03092050
• Other study ID #: MIT001
• Secondary ID: R21AG051970
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: September 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Depression

Intervention

Behavioral:
• Guided Imagery and Mindfulness
This is a behavioral intervention using guided imagery and mindfulness techniques.
• Facilitated Discussion
This is a behavioral intervention that involves discussion and group support.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

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