Clinical trial NCT03092050: Group Therapy for Depressed Dementia Caregivers
Official title: Group Therapy for Depressed Caregivers of Alzheimer's Disorder and Related Dementias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2017-03-27
Enrollment: 46
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Depression symptoms
timeFrame: approximately 4 weeks post initial group session
Secondary outcomes:
measure: Depression symptoms - moderate term
timeFrame: approximately 3 months post initial group session
measure: Depression symptoms - clinician rated
timeFrame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
measure: Caregiver burden
timeFrame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
measure: Anxiety symptoms
timeFrame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
measure: Mindfulness
timeFrame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
measure: Positive and Negative Affect
timeFrame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
measure: Well-Being
timeFrame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
measure: Stress
timeFrame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
measure: Resilience
timeFrame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
measure: Connectedness to Nature
timeFrame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Felipe Jain, MD
role: PRINCIPAL_INVESTIGATOR
References: