Alzheimer's Disease and Related Dementias, Caregiver Stress, Quality of Life
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMindful 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.
BEHAVIORALHealth 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.
Sponsors
Massachusetts General Hospital
National Institute on Aging (NIA)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
MASC is an intervention that includes evidence-based skills of: 1) mindfulness; 2) compassion toward others and self; 3) behavioral management skills. MASC comprises 6 sessions delivered in a group format over secure live video with Zoom. Each session includes psychoeducation on program skills, skill practice, strategies to incorporate the skill into the caregiver experience, and strategies for sustained practice.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Recruitment | 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 | Baseline, Post intervention (6-8 weeks post baseline) | The percentage randomized who complete the post-test. |
| Feasibility of Assessment Measures | 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 | 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 Treatment | 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. |
| Patient's Global Impression of Change (PGIC) | 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" |
| Perceptions of Questionnaire Battery | 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. |
| Adherence to Home Practice | Weekly (up to 6 weeks | The proportion of participants who complete more than 50% weekly home practice. |
| Perceptions of Email and Text Reminders | 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?" |
| Credibility and Expectancy | 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 | (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). |
| Satisfaction With the Intervention | 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). |
| Therapist Fidelity | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAna-Maria Vranceanu, PhD
Massachusetts General Hospital
PRINCIPAL_INVESTIGATORChristine Ritchie, MD, MSPH
Massachusetts General Hospital
Participant flow
Pre-assignment details
82 participants provided informed consent and were enrolled in the study. 14 enrolled participants did not proceed to intervention assignment/start due to withdrawal, loss to follow-up prior to intervention/randomization. Therefore, 68 participants were randomized and started the intervention.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 26 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants |
| Age, Continuous | 57.44 years STANDARD_DEVIATION 12.53 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 53 Participants |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 23 |
| other Total, other adverse events | 0 / 45 | 0 / 23 |
| serious Total, serious adverse events | 0 / 45 | 0 / 23 |
Outcome results
None listed