Massachusetts General Hospital
Boston, Massachusetts, 02114-2524, United States
NCT Number: NCT06276023
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02114-2524, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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.
Time frame: Baseline, Post intervention (6-8 weeks post baseline)
The percentage randomized who complete the post-test.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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"
Time frame: 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.
Time frame: Weekly (up to 6 weeks
The proportion of participants who complete more than 50% weekly home practice.
Time frame: 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?"
Time frame: 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.
Time frame: (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).
Time frame: 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).
Time frame: 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.
Time frame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
Center for Epidemiological Studies-Depression Scale (CES-D). The CES-D is a 20-item scale widely used with Alzheimer's Disease and Related Dementias (ADRD) participants. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time) In scoring the CES-D, possible range of scores is 0 to 60, with the higher scores indicating the presence of more symptomatology.
Time frame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
The Applied Mindfulness Process Scale (AMPS) is a process measure used to quantify how participants in mindfulness-based interventions (MBIs) use mindfulness practice when facing challenges in daily life. The AMPS yields 15 items representing three domains of applied mindfulness processes: (a) decentering, (b) positive emotional regulation, and (c) negative emotional regulation. AMPS is scored by adding all 15 items to obtain a score ranging from 0-60, with higher scores indicating higher use of mindfulness.
Time frame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
The Perceived Stress Scale 10 (PSS-10) assesses perceived stress using a 5-point Likert scale.
The total score is determined by adding together the scores of each of the four items. Questions 2 and 3 are reverse coded. Questions 1 and 4: 0 = Never; 1 = Almost never; 2 = Sometimes; 3 = Fairly often; 4 = Very often Questions 2 and 3: 4 = Never; 3 = Almost never; 2 = Sometimes; 1 = Fairly often; 0 = Very often. Scores range from 0 to 40 with higher scores indicating more stress.
Time frame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
The State Trait Anxiety Inventory (STAI) state subscales (20 items) assesses anxiety symptoms in response to stressful situations. The range of possible scores varies from a minimum score of 20 to a maximum score of 80. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
Time frame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
The Self-Compassion Scale - Short Form (SCS-SF) is a 12-item self-report measure that is used by adults to measure their capacity for self-compassion - the ability to hold one's feelings of suffering with a sense of warmth, connection and concern. All 12 items are scored using a 5-point Likert scale. Before calculating the final score, the following items are reverse-scored so that higher totals always reflect greater self-compassion: negative items that measure harsh self-criticism, isolation, and over-identification (Items 1, 4, 8, 9, 11, 12). Higher scores here indicate a more critical and reactive stance under stress. Positive items that measure self-kindness, common humanity, and mindfulness (Items 2, 3, 5, 6, 7, 10) are left untouched; higher scores mean a warmer, more accepting stance. The finalized 12 scored are summed (the reverse-scored numbers plus the untouched numbers) and divided by 12, for an average overall score between 1.0 and 5.0 with 5 indicating higher SC.
Time frame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
The Compassion Scale (CS) has 16 items assessing common humanity, kindness toward others and ability to understand the suffering or challenges of others, all items scored using a 5 point Likert scale. The items are grouped into 4 categories: Kindness (Items 2, 6, 10, 14), Common Humanity (Items 4, 8, 12, 16), Mindfulness (Items 1, 5, 9, 13), Indifference (Items 3, 7, 11, 15). Indifference items are reverse scored so that a higher number corresponds to higher compassion. The mean of each subscale is calculated. The, using the reverse-coded indifference scores and untouched scores, the grand mean of all 16 items to get the overall compassion score. Total scores will range from 1.0 to 5.0, where higher scores indicate greater overall compassion.
Time frame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
The Revised Caregiver Self-efficacy (RSCSE), assessing domains of self-efficacy including obtaining respite, responding to disruptive patient behaviors and controlling upsetting through, is a 15-item inventory with scores calculated as the mean across items, with higher scores indicating greater self-efficacy. There are 3 5-item subscales: Self-Efficacy for Obtaining Respite, Self-Efficacy for Responding to Disruptive Behaviors, and Self-Efficacy for Controlling Upsetting Thoughts. Each item is rated on a scale from 0-100. The subscale score is calculated by taking the mathematical average of the items within a specific subscale (0 to 100). The total score is calculated by taking the mathematical average of the non-missing items within a specific subscale (0 to 100).
Time frame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
The University of California, Los Angeles (UCLA) 3-item loneliness scale assesses relational connectedness, social connectedness and self-perceived isolation.
The scores for each individual question can be added together to give participants a possible range of scores from 3 to 9. Researchers in the past have grouped people who score 3 - 5 as "not lonely" and people with the score 6 - 9 as "lonely".
Time frame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
The Interpersonal Support Evaluation List short form (ISEL) is a 12-item measure of perceptions of social support. Each of the 12 items is rated on a 4 point Likert scale from 0-3. Items are separated into subscales as follows: Appraisal Support (Items 2, 4, 6, 11), Belonging Support (Items 1, 5, 7, 9) and Tangible Support (Items 3, 8, 10, 12). Negative items (1, 2, 7, 8, 11, 12) are reverse coded. All 12 item scores are summed together, including reverse coded and untouched items, to get a score from 0-36, with higher total scores indicating a stronger perception of available social support.
Time frame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
The World Health Organization-Five Well-Being Index (WHO-D) has 5 items assessing emotional well-being. The raw score is calculated by totaling the figures of the five answers. The raw score ranges from 0 to 25, 0 representing worst possible and 25 representing best possible quality of life.
Time frame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
The Neuropsychiatric Inventory (NPI) Caregiver Distress Scale has 12 items assessing distress associated with dementia patient's behaviors such as apathy, elation, disinhibition. Participant distress is rated for each positive neuropsychiatric symptom domain on a scale anchored by score from 0 to 5 points. The Score is: 0 = Not distressing at all, 1 = Minimal (slightly distressing, not a problem to cope with), 2 = Mild (not very distressing, generally easy to cope with), 3 = Moderate (fairly distressing, not always easy to cope with), 4 = Severe (very distressing, difficult to cope with), 5 = Extreme of Very Severe (extremely distressing, unable to cope with). The scores are added up for all 12 items, and the final score reported below ranges from 0-60 (a lower score indicates lower levels of stress and a better outcome).
Time frame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
The Dyadic Relationship Scale (DRS) (11 items) assesses negative and positive dyadic interactions between caregivers and their care recipient. Each item is rated on four-point scale (0-3) and responses are summed for a total score. Possible scores range from 0 to 33 with higher scores indicating higher levels of strain and positive interaction.
Massachusetts General Hospital
Other
Supporting Our Caregivers In ADRD Learning (SOCIAL): Reducing Stress for Caregivers of Persons With Dementia, a Pilot Randomized Control Trial
Acronym: SOCIAL
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