Trial Outcomes & Findings for MASC: Reducing Stress for Caregivers (NCT NCT05847153)

NCT ID: NCT05847153

Last Updated: 2025-06-17

Results Overview

The investigators will examine feasibility of recruitment overall. The investigators will report proportion of eligible participants who are eligible and choose to enroll in the study. The investigators will also explore the percent of racial and ethnically diverse participants across the entire sample. Benchmark: ≥70% of participants who are eligible will enroll; ≥38% of participants are racial and ethnic minorities (US representation)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 13 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2025-06-17

Participant Flow

Participant milestones

Measure	Intervention The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Overall Study STARTED	13
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MASC: Reducing Stress for Caregivers

Baseline characteristics by cohort

Measure	Intervention n=13 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	62.38 years STANDARD_DEVIATION 14.15 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Perceived Stress Scale (PSS-10)	21.62 units on a scale STANDARD_DEVIATION 7.07 • n=5 Participants
Neuropsychiatric Inventory Questionnaire (NPIQ) NPI- Presence	7 units on a scale STANDARD_DEVIATION 2.71 • n=5 Participants
Neuropsychiatric Inventory Questionnaire (NPIQ) NPI- Severity	13.92 units on a scale STANDARD_DEVIATION 6.87 • n=5 Participants
Neuropsychiatric Inventory Questionnaire (NPIQ) NPI-Distress	17.54 units on a scale STANDARD_DEVIATION 10.32 • n=5 Participants
Center For Epidemiologic Studies Depression Scale	22.15 units on a scale STANDARD_DEVIATION 13.08 • n=5 Participants
Interpersonal Support Evaluation List	35.62 units on a scale STANDARD_DEVIATION 7.1 • n=5 Participants
UCLA Loneliness Scale	6.08 units on a scale STANDARD_DEVIATION 1.89 • n=5 Participants
Positive Affect Index	40.92 units on a scale STANDARD_DEVIATION 10.17 • n=5 Participants
Self-Compassion Scale Short Form	3.06 units on a scale STANDARD_DEVIATION 0.70 • n=5 Participants
Applied Mindfulness Process Scale Amps	34.54 units on a scale STANDARD_DEVIATION 7.92 • n=5 Participants
Compassion Scale	4.23 units on a scale STANDARD_DEVIATION 0.52 • n=5 Participants
Revised Scale For Caregiving Self Efficacy	56.85 units on a scale STANDARD_DEVIATION 12.99 • n=5 Participants
WHO-5 Wellbeing Index	12.23 units on a scale STANDARD_DEVIATION 4.25 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: 16 participants were eligible and 13 chose to enroll. Out of the 13 that chose to enroll, 4 were racial and ethnic minorities.

The investigators will examine feasibility of recruitment overall. The investigators will report proportion of eligible participants who are eligible and choose to enroll in the study. The investigators will also explore the percent of racial and ethnically diverse participants across the entire sample. Benchmark: ≥70% of participants who are eligible will enroll; ≥38% of participants are racial and ethnic minorities (US representation)

Outcome measures

Measure	Intervention n=16 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Feasibility of Recruitment Enrolled Participants	13 Participants
Feasibility of Recruitment Racial and Ethnic Minorities	4 Participants

PRIMARY outcome

Timeframe: Baseline

Population: The number of participants who completed the baseline questionnaire is 13.

The investigators will calculate the proportion of participants completing the study who have less than 25% of missing questionnaires. Benchmark: ≥70% participants will have less than 25% missing questionnaires.

Outcome measures

Measure	Intervention n=13 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Number of Participants With Less Than 25% of Missing Questionnaires at Baseline	13 Participants

PRIMARY outcome

Timeframe: Post-intervention (6-8 weeks post baseline)

Population: While 13 participants completed the baseline survey, only 12/13 participants attended the sessions (intervention). Therefore,12 participants were counted as completing the study, which was measured as those who completed the baseline survey and attended the intervention sessions. 11/12 completed participants completed the post-intervention survey.

The investigators will calculate the proportion of participants completing the study who have less than 25% of missing questionnaires. Benchmark: ≥70% participants will have less than 25% missing questionnaires.

Outcome measures

Measure	Intervention n=12 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Number of Participants With Less Than 25% of Missing Questionnaires at Post-Intervention	11 Participants

PRIMARY outcome

Timeframe: Baseline

The investigators will assess the feasibility of the quantitative measures sent to participants. Benchmark: No questionnaires missing fully in ≥25% participants.

Outcome measures

Measure	Intervention n=13 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Number of Participants With no Questionnaries Missing Fully at Baseline	13 Participants

PRIMARY outcome

Timeframe: Post-intervention (6-8 weeks post baseline)

The investigators will assess the feasibility of the quantitative measures sent to participants. Benchmark: No questionnaires missing fully in ≥25% participants.

Outcome measures

Measure	Intervention n=13 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Number of Participants With no Questionnaries Missing Fully at Post-intervention	11 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

The investigators will use the Center for Epidemiological Studies-Depression Scale (CES-D). This is a 20-item scale widely used with 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.

Outcome measures

Measure	Intervention n=13 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Symptoms of Depression	22.15 score on a scale Standard Deviation 13.08

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-intervention (6-8 weeks post baseline)

Population: 11/13 participants completed the post-intervention CES-D survey.

The investigators will use the Center for Epidemiological Studies-Depression Scale (CES-D). This is a 20-item scale widely used with 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.

Outcome measures

Measure	Intervention n=11 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Symptoms of Depression	16 score on a scale Standard Deviation 9.27

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

The investigators will use the Five Facets Mindfulness Questionnaire (FFMQ) to assess caregivers mindfulness based on 5 subscales (observing, describing, awareness, non-judging, non-reactivity). Average scores are calculated by summing the responses and dividing by the number of items, and indicate the average level of agreement with the each subscale (1 = rarely true, 5 = always true). Higher scores are indicative of someone who is more mindful in their everyday life. Its facet scores range from 3-15.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-intervention (6-8 weeks post baseline)

The investigators will use the Five Facets Mindfulness Questionnaire (FFMQ) to assess caregivers mindfulness based on 5 subscales (observing, describing, awareness, non-judging, non-reactivity). Average scores are calculated by summing the responses and dividing by the number of items, and indicate the average level of agreement with the each subscale (1 = rarely true, 5 = always true). Higher scores are indicative of someone who is more mindful in their everyday life. Its facet scores range from 3-15.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

The investigators will use the Perceived Stress Scale 10 (PSS-10) to assess perceived stress using a 5-point Likert scale.

Scoring Instructions: 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.

Outcome measures

Measure	Intervention n=13 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Perceived Stress Scale	21.62 score on a scale Standard Deviation 7.07

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-intervention (6-8 weeks post baseline)

Population: 11/13 participants completed the post-intervention PSS-10 survey.

The investigators will use the Perceived Stress Scale 10 (PSS-10) to assess perceived stress using a 5-point Likert scale.

Scoring Instructions: 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.

Outcome measures

Measure	Intervention n=11 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Perceived Stress Scale	16.91 score on a scale Standard Deviation 4.44

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

The investigators will use State Trait Anxiety Inventory (STAI) state subscales (20 items) to assess anxiety symptoms in response to stressful situations. STA has been successfully used with ADRD participants.

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).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-intervention (6-8 weeks post baseline)

The investigators will use State Trait Anxiety Inventory (STAI) state subscales (20 items) to assess anxiety symptoms in response to stressful situations. STA has been successfully used with ADRD participants.

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).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

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. Self-Kindness Items: 2, 6 Self-Judgment Items (Reverse Scored): 11, 12 Common Humanity Items: 5, 10 Isolation Items: 4, 8 Mindfulness Items: 3, 7 Over-identification Items : 1, 9 = max score of 8 per category

Outcome measures

Measure	Intervention n=13 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
The Self-Compassion Scale	3.06 score on a scale Standard Deviation 0.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-intervention (6-8 weeks post baseline)

Population: 10/13 participants completed the post-intervention SCS survey.

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. Self-Kindness Items: 2, 6 Self-Judgment Items (Reverse Scored): 11, 12 Common Humanity Items: 5, 10 Isolation Items: 4, 8 Mindfulness Items: 3, 7 Over-identification Items : 1, 9 = max score of 8 per category

Outcome measures

Measure	Intervention n=10 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
The Self-Compassion Scale	3.35 score on a scale Standard Deviation 0.70

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

The Compassion Scale (CS) has 16 items assessing common humanity, kindness toward others and ability to understand the suffering or challenges of others. Kindness items: 2, 6, 10, 14 Common Humanity items: 4, 8, 12, 16 Mindfulness items: 1, 5, 9, 13 Indifference items (reverse scored): 3, 7, 11, 15. Subscale scores are computed by calculating the mean of the four subscale item responses. To compute a total compassion score, reverse score the indifference items then take a grand mean of all items. When examining subscale scores, higher scores on indifference items indicate less compassion before reverse-coding, and more compassion after reverse coding. Participants can choose to report indifference scores with or without reverse-coding, but items must be reverse coded before calculating a total compassion score.

Outcome measures

Measure	Intervention n=13 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Compassion	4.23 score on a scale Standard Deviation 0.52

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-intervention (6-8 weeks post baseline)

Population: 10/13 participants completed the CS post-intervention survey.

The Compassion Scale (CS) has 16 items assessing common humanity, kindness toward others and ability to understand the suffering or challenges of others. Kindness items: 2, 6, 10, 14 Common Humanity items: 4, 8, 12, 16 Mindfulness items: 1, 5, 9, 13 Indifference items (reverse scored): 3, 7, 11, 15. Subscale scores are computed by calculating the mean of the four subscale item responses. To compute a total compassion score, reverse score the indifference items then take a grand mean of all items. When examining subscale scores, higher scores on indifference items indicate less compassion before reverse-coding, and more compassion after reverse coding. Participants can choose to report indifference scores with or without reverse-coding, but items must be reverse coded before calculating a total compassion score.

Outcome measures

Measure	Intervention n=10 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Compassion	4.16 score on a scale Standard Deviation 0.59

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

This scale measures how confident participants are that they can keep up with their own activities and also respond to caregiving situations. There are 10 questions, rated 0 to 100, where 0 is not confident at all and 100 is very confident. The score is calculated by standardizing each score from 0-10 and summing the total. A 0 is the minimum, meaning not confident, and 100 is the maximum, meaning very confident.

Outcome measures

Measure	Intervention n=13 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Caregiver Self-efficacy	56.85 score on a scale Standard Deviation 12.99

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-intervention (6-8 weeks post baseline)

Population: 9/13 participants completed the RSCSE post-intervention survey.

This scale measures how confident participants are that they can keep up with their own activities and also respond to caregiving situations. There are 10 questions, rated 0 to 100, where 0 is not confident at all and 100 is very confident. The score is calculated by standardizing each score from 0-10 and summing the total. A 0 is the minimum, meaning not confident, and 100 is the maximum, meaning very confident.

Outcome measures

Measure	Intervention n=9 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Caregiver Self-efficacy	58.33 score on a scale Standard Deviation 15.72

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

The University of California, Los Angeles (UCLA) 3-item loneliness scale assess 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".

Outcome measures

Measure	Intervention n=13 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Loneliness	6.08 score on a scale Standard Deviation 1.89

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-intervention (6-8 weeks post baseline)

Population: 11/13 participants completed the UCLA post-intervention survey.

The University of California, Los Angeles (UCLA) 3-item loneliness scale assess 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".

Outcome measures

Measure	Intervention n=11 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Loneliness	5.91 score on a scale Standard Deviation 1.81

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Interpersonal Support Evaluation List short form (ISEL) has 12 items assessing appraisal, belonging and tangible social support.

A 12-item measure of perceptions of social support. Response options range from 1-4 with 4 = "definitely true" if the participant is sure it is true about them, 3= "probably true" if the participant thinks it is true but is not absolutely certain. Similarly, the participant should circle 1 = "definitely false" if they are sure the statement is false and 2 = "probably false" if the participant thinks it is false but is not absolutely certain. This questionnaire has three different subscales designed to measure three dimensions of perceived social support. These dimensions are: 1.) Appraisal Support 2.) Belonging Support 3.) Tangible Support Each dimension is measured by 4 items on a 4-point scale ranging from "Definitely True" to "Definitely False". The minimum score is 12 and the maximum is 48. Higher scores are a better outcome.

Outcome measures

Measure	Intervention n=13 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Social Support	35.62 score on a scale Standard Deviation 7.10

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-intervention (6-8 weeks post baseline)

Population: 11/13 participants completed the ISEL post-intervention survey.

A 12-item measure of perceptions of social support. Response options range from 1-4 with 4 = "definitely true" if the participant is sure it is true about them, 3= "probably true" if the participant thinks it is true but is not absolutely certain. Similarly, the participant should circle 1 = "definitely false" if they are sure the statement is false and 2 = "probably false" if the participant thinks it is false but is not absolutely certain. This questionnaire has three different subscales designed to measure three dimensions of perceived social support. These dimensions are: 1.) Appraisal Support 2.) Belonging Support 3.) Tangible Support Each dimension is measured by 4 items on a 4-point scale ranging from "Definitely True" to "Definitely False". The minimum score is 12 and the maximum is 48. Higher scores are a better outcome.

Outcome measures

Measure	Intervention n=11 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Social Support	37.73 score on a scale Standard Deviation 6.37

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

World Health Organization-Five Well-Being Index (WHO-5) 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 The outcome measure represents the mean of the raw score.

Outcome measures

Measure	Intervention n=13 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Well-being	12.23 score on a scale Standard Deviation 4.25

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-intervention (6-8 weeks post baseline)

Population: 9/13 participants complete the WHO post-intervention survey.

World Health Organization-Five Well-Being Index (WHO-5) 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 The outcome measure represents the mean of the raw score.

Outcome measures

Measure	Intervention n=9 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Well-being	15 score on a scale Standard Deviation 4.27

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

The Neuropsychiatric Inventory 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 minimum is 0, indicating less distress and a better outcome and he maximum is 60, indicating more distress and a worse outcome.

Outcome measures

Measure	Intervention n=13 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Distress Due to Patient Challenges Behaviors	17.54 score on a scale Standard Deviation 10.32

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-intervention (6-8 weeks post baseline)

Population: 11/13 participants completed the NPI distress post-intervention survey.

The Neuropsychiatric Inventory 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 minimum is 0, indicating less distress and a better outcome and he maximum is 60, indicating more distress and a worse outcome.

Outcome measures

Measure	Intervention n=11 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Distress Due to Patient Challenges Behaviors	15.55 score on a scale Standard Deviation 7.92

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-intervention (6-8 weeks post baseline)

Population: 10/13 participants completed the CSQ post-intervention survey.

The investigators will use the Client Satisfaction Questionnaire (CSQ-3) to assess participants' satisfaction with the intervention. The questionnaire consists of 3 questions rating participants' satisfaction on a scale of 1-4, with 1 being not satisfied at all and 4 being very satisfied. Total possible score is 12 and the least possible score is 3.

Outcome measures

Measure	Intervention n=10 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Satisfaction With the Intervention	10.5 score on a scale Standard Deviation 1.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-intervention (6-8 weeks post baseline)

Population: 10/13 participants completed the PGIC post-intervention survey.

The investigators will ask participants about their perceptions of whether or not they feel that they improved in stress, depression, anxiety and wellbeing. PGIC is a 5 point scale depicting a participant's rating of overall improvement. Participants rate their change as "much improved", "minimally improved", "no change", "minimally worse", or "much worse". A score of 1 is much worse and 5 is much improved.

Outcome measures

Measure	Intervention n=10 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Patient's Global Impression of Change (PGIC)	4.4 score on a scale Standard Deviation 0.70

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through Post-intervention (6-8 weeks post baseline)

Population: Both groups were analyzed with 6 sessions in each group. Number of participants in both sessions varied from 9-12.

The investigators will assess both therapists' ability to deliver the content of each session (through therapist completed adherence checklists) and therapist fidelity (through independent review of recorded sessions by Co-Investigator). Ratings will be given for each of six sessions on the following scale: 1=Not Present,3=Slightly Present,5=Moderately Present,7=Often Present,10=Always Present. An average score of 10 for all sessions represents all content always delivered, and an average score of 1 represents no content delivered as intended. Benchmark: >=75% of MASC sessions components delivered as intended; 20% sessions rated.

Outcome measures

Measure	Intervention n=60 Sessions The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Therapist Fidelity	8.9 score on a scale Standard Deviation 0.47

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-intervention (6-8 weeks post baseline)

The investigators will use the 'Perceptions of Questionnaire Battery' qualitative measure to assess how appropriately the participants fill the questionnaires, address their perception of stress, emotional distress and all other questionnaires.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Weekly (up to 5 weeks)

Population: 12/13 participants attended sessions and were sent homepractice surveys.

The investigators will report proportion of participants who complete weekly home practice.

Outcome measures

Measure	Intervention n=12 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Adherence to Home Practice Week 4	6 Participants
Adherence to Home Practice Week 1	10 Participants
Adherence to Home Practice Week 2	8 Participants
Adherence to Home Practice Week 3	8 Participants
Adherence to Home Practice Week 5	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-intervention (6-8 weeks post baseline)

The investigators will assess participants' perception of emails and text messages reminders by asking, "Do participants think that the amount of emails/texts received was: too little, just enough, too much?"

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-Intervention

Population: 9/13 participants filled out the post-intervention CEQ survey.

The investigators will use the Credibility and Expectancy Questionnaire (CEQ) to assess participants' perceptions that the treatment will work after participating in the intervention. The CEQ utilizes two scales during the administration (1-9, and 0-100%), and so a composite score was derived for each factor (expectancy and credibility) by first standardizing the individual items and then summing those items for each factor. The minimum score is a 1, indicating worse outcome and less credibility and the maximum score is a 9, indicating a better outcome and more credibility.

Outcome measures

Measure	Intervention n=9 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Credibility and Expectancy	8 score on a scale Standard Deviation 0.71

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

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. Development and validation of the AMPS yielded 15 items representing three domains of applied mindfulness processes: (a) decentering, (b) positive emotional regulation, and (c) negative emotional regulation. Increases over time in AMPS scores suggest greater application of the use of mindfulness skills in daily life coinciding with mindfulness practice. Instructions for scoring:(1) Sum each factor individually to obtain a score ranging from 0-20, and/or (2) sum all 15 items to obtain a score ranging from 0-60. This is used as a replacement for the FFMQ.

Outcome measures

Measure	Intervention n=13 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Applied Mindfulness Process Scale	34.54 score on a scale Standard Deviation 7.92

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-intervention (6-8 weeks post baseline)

Population: 10/13 participants completed the post-intervention AMPS survey.

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. Development and validation of the AMPS yielded 15 items representing three domains of applied mindfulness processes: (a) decentering, (b) positive emotional regulation, and (c) negative emotional regulation. Increases over time in AMPS scores suggest greater application of the use of mindfulness skills in daily life coinciding with mindfulness practice. Instructions for scoring:(1) Sum each factor individually to obtain a score ranging from 0-20, and/or (2) sum all 15 items to obtain a score ranging from 0-60. This is used as a replacement for the FFMQ.

Outcome measures

Measure	Intervention n=10 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Applied Mindfulness Process Scale	38 score on a scale Standard Deviation 10.44

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-intervention (6-8 weeks post baseline)

Population: 9/13 participants completed the MPGI post-intervention survey.

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. 0 indicates not improved and 1 indicates improved.

Outcome measures

Measure	Intervention n=9 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Modified Perception of Global Improvement	0.89 score on a scale Standard Deviation 0.33

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

The Positive Affect Index (PAI) (5 items) assesses communication quality, closeness, similarity of views on life, engagement in joint activities and overall relationship quality. Each item is rated on a six-point scale and responses are summed for a total score. Possible scores range from 10 to 60 with higher scores indicating better relationship quality.

Outcome measures

Measure	Intervention n=13 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Positive Affect Index	40.92 score on a scale Standard Deviation 10.17

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-intervention (6-8 weeks post baseline)

Population: 10/13 participants completed the PAI post-intervention survey.

The Positive Affect Index (PAI) (5 items) assesses communication quality, closeness, similarity of views on life, engagement in joint activities and overall relationship quality. Each item is rated on a six-point scale and responses are summed for a total score. Possible scores range from 10 to 60 with higher scores indicating better relationship quality.

Outcome measures

Measure	Intervention n=10 Participants The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Positive Affect Index	38 score on a scale Standard Deviation 8.90

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christine Ritchie

Massachusetts General Hospital

Phone: 4156721780

Email: csritchie@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place