Group Therapy for Depressed Caregivers of Alzheimer's Disorder and Related Dementias
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Depression symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Endorse clinically relevant baseline depressive symptoms Primary caregiver for a relative with dementia
排除标准
- •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.
结局指标
主要结局
Depression symptoms
时间窗: approximately 4 weeks post initial group session
Self reported depression symptoms (Quick Inventory of Depression Symptoms)
次要结局
- Depression symptoms - moderate term(approximately 3 months post initial group session)
- Mindfulness(approximately 4 weeks post initial group session and approximately 3 months post initial group session)
- Positive and Negative Affect(approximately 4 weeks post initial group session and approximately 3 months post initial group session)
- Stress(approximately 4 weeks post initial group session and approximately 3 months post initial group session)
- Well-Being(approximately 4 weeks post initial group session and 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)
- Resilience(approximately 4 weeks post initial group session and approximately 3 months post initial group session)
- Connectedness to Nature(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)
研究者
Felipe A Jain
Psychiatrist
Massachusetts General Hospital