Supporting Our Caregivers In ADRD Learning (SOCIAL): Reducing Stress for Caregivers of Persons With Dementia, a Pilot Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Feasibility of Recruitment
研究概览
简要总结
Building on limitations of prior research, the investigators developed the Mindful and Self-Compassionate Care Program (MASC) to help caregivers of persons with Alzheimer Disease and Related Dementias (ADRD) manage stress associated with the general caregiver experience including stress stemming from managing challenging patient behaviors. MASC teaches: (1) mindfulness skills; (2) compassion and self-compassion skills; and (3) behavioral management skills. MASC also provides psychoeducation and group-based training and skill practice to facilitate skill uptake and integration within the caregiver experience and tasks.
The main aim is to: Demonstrate feasibility, acceptability, credibility, fidelity, preliminary efficacy and evidence for proposed mechanism of MASC through a pilot randomized controlled trial.
Relevant stakeholders (caregivers of persons with ADRD) will participate in the intervention.
详细描述
Over half of Alzheimer Disease and Related Dementias (ADRD) caregivers are actively looking for non-pharmacological interventions to decrease caregiver stress. Available programs do not sufficiently meet the psychological and practical needs of stressed caregivers of persons with ADRD; better solutions are needed. First, while helpful, most support groups do not systematically teach behavioral management skills which caregivers report needing in order to manage challenging patient behaviors. Second, behavioral management skills interventions exist, but do not teach: 1) emotional regulation skills which are necessary in order to foster caregiver ability to access and use these skills to manage patient behaviors, and/or 2) self-compassion and compassion skills which are necessary to bypass guilt and loneliness and navigate behavioral symptoms which are common caregiver challenges. Third, mindfulness and self-compassion interventions are effective solutions for managing stress, and distress across multiple populations, but engagement and efficacy among diverse ADRD caregivers are limited.
The guiding hypothesis of this proposal is that combining evidence-based mindfulness and self-compassion skills with behavioral management skills within a multi-component program increases intervention potency and efficiently supports caregivers of persons with ADRD. Accounting for practical challenges to engagement (number of sessions, delivery modality, skill practice) will also enhance uptake and reach.
The investigators will conduct a randomized-controled trial (RCT) study to explore feasibility benchmarks, target engagement and signal of improvement in stress, depression, anxiety and wellbeing (NIH stage 1B; N= up to 88 caregivers). The investigators will recruit caregivers of persons with ADRD from local community organizations and caregiver support programs; dementia research programs; and from national programs that focus on caregiving.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •English fluency and literacy
- •Meeting criteria for being a caregiver (e.g., family or friend of a care recipient who provides unpaid care)
- •Must live with and care for an individual with ADRD
- •Must have been in a caregiver role for more than 6 months
- •Must provide an average 4 hours of supervision or direct assistance per day for the are recipient
- •Perceived Stress Scale-4 (4-item) version ≥ 6
- •Had managed 1 or more behavioral symptoms in past month
排除标准
- •Recent (within the past 6 weeks) change in prescribed medications for depression or anxiety
- •Use of mindfulness apps or any meditation (more than 60 min/week in past 3 months)
- •Involvement in another clinical trial for caregivers, a score ≥ 4 on the Portable Mental Status Questionnaire (PMSQ)
- •No stated concerns or distress related to care recipient's disruptive behaviors
- •Involvement in another clinical trial for caregivers
研究组 & 干预措施
Mindful and Self-Compassionate Care Program (MASC)
The intervention arm will be comprised of:
Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills.
At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
干预措施: Mindful and Self-Compassionate Care Program (MASC) (Behavioral)
Health Education Program (HEP)
The control arm will be comprised of:
Six Virtual Group Sessions. The sessions will discuss caregiver stress, sleep hygiene, nutrition, and ways to stay physically active as a caregiver.
At Home Practice. After each group session, participants will have the opportunity to complete journal exercises that encourage them to integrate the health information that they learn into their daily lives.
干预措施: Health Education Program (HEP) (Behavioral)
结局指标
主要结局
Feasibility of Recruitment
时间窗: Baseline
The proportion of eligible participants who are eligible and choose to enroll in the study and the percentage of racial and ethnically diverse participants enrolled.
Feasibility of Randomization
时间窗: Baseline, Post intervention (6-8 weeks post baseline)
The percentage randomized who complete the post-test.
Adherence to treatment
时间窗: Post-intervention
The proportion of caregivers who attend at least 4 out of the 6 sessions out of all randomized caregivers. Adherence to treatment will be estimated for both HEP and MASC.
Perceptions of Questionnaire Battery
时间窗: Post-intervention (6-8 weeks post baseline)
The 'Perceptions of Questionnaire Battery' qualitative measure assesses how appropriately the participants fill the questionnaires, address their perception of stress, emotional distress and all other questionnaires.
Perceptions of Email and Text Reminders
时间窗: Post-intervention (6-8 weeks post baseline)
Participants' perception of emails and text messages reminders. The single question -, "Do participants think that the number of emails/texts received was: too little, just enough, too much?"
Patient's Global Impression of Change (PGIC)
时间窗: Post-intervention (6-8 weeks post baseline)
PGIC is a 7-point scale depicting a participant's rating of overall improvement. Participants rate their change as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse" or "very much worse"
Satisfaction with the Intervention
时间窗: Post-intervention (6-8 weeks post baseline)
The investigators will use the Client Satisfaction Questionnaire (CSQ-3) to assess participants' satisfaction with the intervention.
Adherence to Treatment
时间窗: Post-intervention (Up to 8 weeks post baseline)
The proportion of caregivers who attend at least 4 out of the 6 sessions out of all randomized caregivers. Adherence to treatment will be estimated for both HEP and MASC.
Feasibility of Assessment Measures
时间窗: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
The proportion of participants who completed the study and had fewer than 25% of all expected study questionnaires missing across the entire assessment period. This participant-level measure assessed overall study completion and questionnaire adherence.
Feasibility of Quantitative Measures
时间窗: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
Assessing whether at least 75% of participants completed every study question in the questionnaire (of note: no questionnaire in this study was entirely missing). The benchmark was met if no more than 25% of participants had one or more questionnaires that were completely missing.
Adherence to Home Practice
时间窗: Weekly (up to 6 weeks
The proportion of participants who complete more than 50% weekly home practice.
Credibility and Expectancy
时间窗: Baseline
The Credibility and Expectancy Questionnaire (CEQ) assesses participants' perceptions that the treatment will work after participating in the intervention. It consists of 6 items divided into two subscales, with scoring is based on dividing the items into Credibility and Expectancy. Items 1-3: Assess Treatment Credibility, scored on a 1 to 9 scale (where 1 represents "not at all" and 9 represents "very much"; the subscale score is the sum of these three items, range: 3-27; a higher score indicates a better outcome). Items 4-6: Assess Treatment Expectancy, scored on a 0% to 100% scale (values are recoded to match the 1 to 9 scale of the previous items; once recoded, values range from 3-27; higher scores represent a better outcome). Credibility Score: Calculate the sum (or average) of items 1-3; a higher score indicates a better outcome. Expectancy Score: Calculate the sum (or average) of items 4-6; a higher score indicates a better outcome.
Modified Perception of Global Improvement
时间窗: (6-8 weeks post baseline)
The Modified Perception of Global Improvement (MPGI) is a global index designed to measure a participant's interpretation of changes in perceptions of stress following intervention. The MPGI uses a 7-point Likert scale, with 1 = Very Much Improved and 7 = Very Much Worse (lower score represents a better outcome). For the data below, the scores were converted as follows: Improved - original scores of 1-3 converted to a zero Not improved - original score 4-7 converted to a 1. The averages of the converted scores were computed, with a score ranging from 0-1 (with a lower score representing a better outcome).
Therapist Fidelity
时间窗: Baseline through Post-intervention (6-8 weeks post baseline)
Ability of therapist to deliver the content of each session (through therapist completed adherence checklists) and therapist fidelity (through independent review of recorded sessions by Co-Investigator). To measure this outcome, recorded sessions were analyzed.
Satisfaction With the Intervention
时间窗: Post-intervention (6-8 weeks post baseline)
The investigators will use the Client Satisfaction Questionnaire (CSQ-3) to assess participants' satisfaction with the intervention. Each of the three questions is scored on a 4-point Likert scale ranging from 1 to 4, where higher numbers indicate greater satisfaction. To calculate the score, you add up the responses from the three questions. Total Score Range: 3 to 12 (higher score represents better outcome).
次要结局
未报告次要终点
研究者
Christine S. Ritchie, MD, MPH
Professor of Medicine
Massachusetts General Hospital