Group Therapy for Depressed Dementia Caregivers

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03092050
• Collaborator: National Institute on Aging (NIA) (NIH)
• Enrollment: 46
• Location: 1
• Arms: 2
• Actual Duration (Months): 28
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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 50 depressed caregivers, to determine the efficacy and mechanisms of group therapy for depressed dementia caregivers.

Condition or Disease	Intervention/Treatment	Phase
Depression	Behavioral: Guided Imagery and Mindfulness; Behavioral: Facilitated Discussion	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 2 arm randomized controlled trial2 arm randomized controlled trial
• Masking: Single (Participant)
• Masking Description: Blinded to study hypotheses.
• Primary Purpose: Treatment
• Official Title: Group Therapy for Depressed Caregivers of Alzheimer's Disorder and Related Dementias
• Actual Study Start Date: Mar 1, 2017
• Actual Primary Completion Date: Jun 30, 2019
• Actual Study Completion Date: Jun 30, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Depression symptoms [approximately 4 weeks post initial group session]

   Self reported depression symptoms (Quick Inventory of Depression Symptoms)

Secondary Outcome Measures

1. Depression symptoms - moderate term [approximately 3 months post initial group session]

   Self reported depression symptoms

2. Depression symptoms - clinician rated [approximately 4 weeks post initial group session and approximately 3 months post initial group session]

   Hamilton Depression Rating Scale

3. Caregiver burden [approximately 4 weeks post initial group session and approximately 3 months post initial group session]

   Caregiver Burden Scale self rated questionnaire

4. Anxiety symptoms [approximately 4 weeks post initial group session and approximately 3 months post initial group session]

   State Trait Anxiety Inventory - Trait

5. Mindfulness [approximately 4 weeks post initial group session and approximately 3 months post initial group session]

   Five Factor Mindfulness Questionnaire

6. Positive and Negative Affect [approximately 4 weeks post initial group session and approximately 3 months post initial group session]

   Positive and Negative Affect Scale

7. Well-Being [approximately 4 weeks post initial group session and approximately 3 months post initial group session]

   Mental Health Continuum Short Form

8. Stress [approximately 4 weeks post initial group session and approximately 3 months post initial group session]

   Perceived Stress Scale

9. Resilience [approximately 4 weeks post initial group session and approximately 3 months post initial group session]

   Connors Davidson Resilience Scale

10. Connectedness to Nature [approximately 4 weeks post initial group session and approximately 3 months post initial group session]

    Connectedness to Nature Scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital
• National Institute on Aging (NIA)

Investigators

• Principal Investigator: Felipe Jain, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Felipe A Jain, Psychiatrist, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT03092050
• Other Study ID Numbers: MIT001; R21AG051970
• First Posted: Mar 27, 2017
• Last Update Posted: Mar 24, 2020
• Last Verified: Mar 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dementia

Study Results

No Results Posted as of Mar 24, 2020