Group Therapy for Depressed Dementia Caregivers

NCT03092050 | Completed

• 2 other identifiers: MIT001R21AG051970
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Depression symptoms

  Self reported depression symptoms (Quick Inventory of Depression Symptoms)

  approximately 4 weeks post initial group session

Secondary Outcomes (10)

• Depression symptoms - moderate term

  approximately 3 months post initial group session

• Depression symptoms - clinician rated

  approximately 4 weeks post initial group session and approximately 3 months post initial group session

• Caregiver burden

  approximately 4 weeks post initial group session and approximately 3 months post initial group session

• Anxiety symptoms

  approximately 4 weeks post initial group session and approximately 3 months post initial group session

• Mindfulness

  approximately 4 weeks post initial group session and approximately 3 months post initial group session

Study Arms (2)

Facilitated Discussion

ACTIVE COMPARATOR

Weekly facilitated discussion for 4 weeks

Behavioral: Facilitated Discussion

Guided Imagery and mindfulness

EXPERIMENTAL

Weekly guided imagery and mindfulness for 4 weeks

Behavioral: Guided Imagery and Mindfulness

Interventions

Guided Imagery and Mindfulness BEHAVIORAL

This is a behavioral intervention using guided imagery and mindfulness techniques.

Guided Imagery and mindfulness

Facilitated Discussion BEHAVIORAL

This is a behavioral intervention that involves discussion and group support.

Facilitated Discussion

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Endorse clinically relevant baseline depressive symptoms Primary caregiver for a relative with dementia

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Imagery, Psychotherapy; Mindfulness

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Behavior Therapy

Study Officials

• Felipe Jain, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blinded to study hypotheses. Under UCSF IRB #16-20163, on 07.21.2016 (prior to participant enrollment), IRB approval was received for a single-blind study (participant blinding only) due to funding constraints.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist

Model Details: 2 arm randomized controlled trial. During the conduct of the trial, the investigators noted that due to staffing constraints, participant availability, and funding limitations, it would not be feasible to complete a crossover study. This was due to the fact that the investigators were unable to offer crossover group therapy visits at the same time as the initial group sessions. Rather, groups with new participants had to be prioritized and scheduled during the most accessible time slots. Times that the investigators could offer for crossover groups were often inaccessible to participants. Thus, the investigators determined that in the context of this pilot trial, it was not feasible to conduct a full crossover trial due to accessibility. The trial design was therefore updated to parallel (in accordance with the initial funding application).

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 27, 2017
• Study Start: March 1, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: September 6, 2022

Record last verified: 2022-09

Locations

US (1)