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Completed

NCT Number: NCT03092050

Group Therapy for Depressed Dementia Caregivers

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Guided Imagery and Mindfulness

Behavioral

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

Facilitated Discussion

Behavioral

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

Primary outcomes

  1. Depression symptoms

    Time frame: approximately 4 weeks post initial group session

    Self reported depression symptoms (Quick Inventory of Depression Symptoms)

Secondary outcomes

  1. Depression symptoms - moderate term

    Time frame: approximately 3 months post initial group session

    Self reported depression symptoms

  2. Depression symptoms - clinician rated

    Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session

    Hamilton Depression Rating Scale

  3. Caregiver burden

    Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session

    Caregiver Burden Scale self rated questionnaire

  4. Anxiety symptoms

    Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session

    State Trait Anxiety Inventory - Trait

  5. Mindfulness

    Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session

    Five Factor Mindfulness Questionnaire

  6. Positive and Negative Affect

    Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session

    Positive and Negative Affect Scale

  7. Well-Being

    Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session

    Mental Health Continuum Short Form

  8. Stress

    Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session

    Perceived Stress Scale

  9. Resilience

    Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session

    Connors Davidson Resilience Scale

  10. Connectedness to Nature

    Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session

    Connectedness to Nature Scale

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 27, 2017
Registry last updated
Sep 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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