Group Therapy for Depressed Dementia Caregivers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2019-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Reducing Depression in Dementia Caregivers

NCT00056316

Depression

COMPLETED PHASE1/PHASE2

Mobile App Psychological Interventions for Family Dementia Caregivers

NCT05253443

Family Caregivers

COMPLETED NA

Mindfulness to Reduce Loneliness in Older Caregivers

NCT04560088

Social Isolation Loneliness

COMPLETED NA

Dementia Caregiver Chronic Grief Management: A Live Online Video Intervention

NCT03593070

Chronic Grief Dementia Family Caregivers

COMPLETED NA

Telephone-delivered Mindfulness Intervention for African American Dementia Caregivers

NCT04058886

Alzheimer Dementia Caregiver Dementia Alzheimers

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Facilitated Discussion

Weekly facilitated discussion for 4 weeks

Group Type ACTIVE_COMPARATOR

Facilitated Discussion

Intervention Type BEHAVIORAL

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

Guided Imagery and mindfulness

Weekly guided imagery and mindfulness for 4 weeks

Group Type EXPERIMENTAL

Guided Imagery and Mindfulness

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Guided Imagery and Mindfulness

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

Intervention Type BEHAVIORAL

Facilitated Discussion

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No