Alzheimer Disease and Related Dementias, Dementia Alzheimers
Conditions
Keywords
ADRD, Caregiver stress, Dementia, Alzheimer, Self-compassion
Brief summary
Building on limitations of prior research, the investigators proposed to develop 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.
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 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 (nr. sessions, delivery modality, skill practice) will also enhance uptake and reach. The investigators will conduct an open pilot with exit interviews to explore feasibility benchmarks, target engagement and signal of improvement in stress, depression, anxiety and wellbeing (NIH stage 1A; N= up to 20 caregivers; N= up to 2 groups. Exit interviews will last 30 minutes and will be recorded, transcribed, and analyzed to refine study procedures. The investigators will use this information to revise and optimize MASC and our conceptual model, as needed to maximize feasibility and target engagement. 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
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.
Sponsors
Study design
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 has 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
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 change ini psychotropic treatment for depression or anxiety * Use of mindfulness apps or any meditation (more than 60 min/week in past 6 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 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) |
| Number of Participants With Less Than 25% of Missing Questionnaires at Baseline | Baseline | 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. |
| Number of Participants With Less Than 25% of Missing Questionnaires at Post-Intervention | Post-intervention (6-8 weeks post baseline) | 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. |
| Number of Participants With no Questionnaries Missing Fully at Baseline | Baseline | The investigators will assess the feasibility of the quantitative measures sent to participants. Benchmark: No questionnaires missing fully in ≥25% participants. |
| Number of Participants With no Questionnaries Missing Fully at Post-intervention | 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. |
Countries
United States
Contacts
Massachusetts General Hospital
Massachusetts General Hospital
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 62.38 years STANDARD_DEVIATION 14.15 |
| Applied Mindfulness Process Scale Amps | 34.54 units on a scale STANDARD_DEVIATION 7.92 |
| Center For Epidemiologic Studies Depression Scale | 22.15 units on a scale STANDARD_DEVIATION 13.08 |
| Compassion Scale | 4.23 units on a scale STANDARD_DEVIATION 0.52 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Interpersonal Support Evaluation List | 35.62 units on a scale STANDARD_DEVIATION 7.1 |
| Neuropsychiatric Inventory Questionnaire (NPIQ) NPI-Distress | 17.54 units on a scale STANDARD_DEVIATION 10.32 |
| Neuropsychiatric Inventory Questionnaire (NPIQ) NPI- Presence | 7 units on a scale STANDARD_DEVIATION 2.71 |
| Neuropsychiatric Inventory Questionnaire (NPIQ) NPI- Severity | 13.92 units on a scale STANDARD_DEVIATION 6.87 |
| Perceived Stress Scale (PSS-10) | 21.62 units on a scale STANDARD_DEVIATION 7.07 |
| Positive Affect Index | 40.92 units on a scale STANDARD_DEVIATION 10.17 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Revised Scale For Caregiving Self Efficacy | 56.85 units on a scale STANDARD_DEVIATION 12.99 |
| Self-Compassion Scale Short Form | 3.06 units on a scale STANDARD_DEVIATION 0.7 |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 2 Participants |
| UCLA Loneliness Scale | 6.08 units on a scale STANDARD_DEVIATION 1.89 |
| WHO-5 Wellbeing Index | 12.23 units on a scale STANDARD_DEVIATION 4.25 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Feasibility of Recruitment
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)
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Feasibility of Recruitment | Enrolled Participants | 13 Participants |
| Intervention | Feasibility of Recruitment | Racial and Ethnic Minorities | 4 Participants |
Number of Participants With Less Than 25% of Missing Questionnaires at Baseline
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.
Time frame: Baseline
Population: The number of participants who completed the baseline questionnaire is 13.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Number of Participants With Less Than 25% of Missing Questionnaires at Baseline | 13 Participants |
Number of Participants With Less Than 25% of Missing Questionnaires at Post-Intervention
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Number of Participants With Less Than 25% of Missing Questionnaires at Post-Intervention | 11 Participants |
Number of Participants With no Questionnaries Missing Fully at Baseline
The investigators will assess the feasibility of the quantitative measures sent to participants. Benchmark: No questionnaires missing fully in ≥25% participants.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Number of Participants With no Questionnaries Missing Fully at Baseline | 13 Participants |
Number of Participants With no Questionnaries Missing Fully at Post-intervention
The investigators will assess the feasibility of the quantitative measures sent to participants. Benchmark: No questionnaires missing fully in ≥25% participants.
Time frame: Post-intervention (6-8 weeks post baseline)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Number of Participants With no Questionnaries Missing Fully at Post-intervention | 11 Participants |
Adherence to Home Practice
The investigators will report proportion of participants who complete weekly home practice.
Time frame: Weekly (up to 5 weeks)
Population: 12/13 participants attended sessions and were sent homepractice surveys.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Adherence to Home Practice | Week 1 | 10 Participants |
| Intervention | Adherence to Home Practice | Week 2 | 8 Participants |
| Intervention | Adherence to Home Practice | Week 3 | 8 Participants |
| Intervention | Adherence to Home Practice | Week 4 | 6 Participants |
| Intervention | Adherence to Home Practice | Week 5 | 7 Participants |
Applied Mindfulness Process Scale
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.
Time frame: Post-intervention (6-8 weeks post baseline)
Population: 10/13 participants completed the post-intervention AMPS survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Applied Mindfulness Process Scale | 38 score on a scale | Standard Deviation 10.44 |
Applied Mindfulness Process Scale
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Applied Mindfulness Process Scale | 34.54 score on a scale | Standard Deviation 7.92 |
Caregiver Self-efficacy
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Caregiver Self-efficacy | 56.85 score on a scale | Standard Deviation 12.99 |
Caregiver Self-efficacy
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.
Time frame: Post-intervention (6-8 weeks post baseline)
Population: 9/13 participants completed the RSCSE post-intervention survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Caregiver Self-efficacy | 58.33 score on a scale | Standard Deviation 15.72 |
Compassion
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Compassion | 4.23 score on a scale | Standard Deviation 0.52 |
Compassion
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.
Time frame: Post-intervention (6-8 weeks post baseline)
Population: 10/13 participants completed the CS post-intervention survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Compassion | 4.16 score on a scale | Standard Deviation 0.59 |
Credibility and Expectancy
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.
Time frame: Post-Intervention
Population: 9/13 participants filled out the post-intervention CEQ survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Credibility and Expectancy | 8 score on a scale | Standard Deviation 0.71 |
Distress Due to Patient Challenges Behaviors
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.
Time frame: Post-intervention (6-8 weeks post baseline)
Population: 11/13 participants completed the NPI distress post-intervention survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Distress Due to Patient Challenges Behaviors | 15.55 score on a scale | Standard Deviation 7.92 |
Distress Due to Patient Challenges Behaviors
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Distress Due to Patient Challenges Behaviors | 17.54 score on a scale | Standard Deviation 10.32 |
Loneliness
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Loneliness | 6.08 score on a scale | Standard Deviation 1.89 |
Loneliness
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.
Time frame: Post-intervention (6-8 weeks post baseline)
Population: 11/13 participants completed the UCLA post-intervention survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Loneliness | 5.91 score on a scale | Standard Deviation 1.81 |
Mindfulness
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.
Time frame: Post-intervention (6-8 weeks post baseline)
Mindfulness
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.
Time frame: Baseline
Modified Perception of Global Improvement
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.
Time frame: Post-intervention (6-8 weeks post baseline)
Population: 9/13 participants completed the MPGI post-intervention survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Modified Perception of Global Improvement | 0.89 score on a scale | Standard Deviation 0.33 |
Patient's Global Impression of Change (PGIC)
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.
Time frame: Post-intervention (6-8 weeks post baseline)
Population: 10/13 participants completed the PGIC post-intervention survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Patient's Global Impression of Change (PGIC) | 4.4 score on a scale | Standard Deviation 0.7 |
Perceived Stress Scale
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Perceived Stress Scale | 21.62 score on a scale | Standard Deviation 7.07 |
Perceived Stress Scale
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.
Time frame: Post-intervention (6-8 weeks post baseline)
Population: 11/13 participants completed the post-intervention PSS-10 survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Perceived Stress Scale | 16.91 score on a scale | Standard Deviation 4.44 |
Perceptions of Email and Text Reminders
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?
Time frame: Post-intervention (6-8 weeks post baseline)
Perceptions of Questionnaire Battery
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.
Time frame: Post-intervention (6-8 weeks post baseline)
Positive Affect Index
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.
Time frame: Post-intervention (6-8 weeks post baseline)
Population: 10/13 participants completed the PAI post-intervention survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Positive Affect Index | 38 score on a scale | Standard Deviation 8.9 |
Positive Affect Index
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Positive Affect Index | 40.92 score on a scale | Standard Deviation 10.17 |
Satisfaction With the Intervention
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.
Time frame: Post-intervention (6-8 weeks post baseline)
Population: 10/13 participants completed the CSQ post-intervention survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Satisfaction With the Intervention | 10.5 score on a scale | Standard Deviation 1.9 |
Social Support
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Social Support | 35.62 score on a scale | Standard Deviation 7.1 |
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.
Time frame: Post-intervention (6-8 weeks post baseline)
Population: 11/13 participants completed the ISEL post-intervention survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Social Support | 37.73 score on a scale | Standard Deviation 6.37 |
Symptoms of Anxiety
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).
Time frame: Baseline
Symptoms of Anxiety
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).
Time frame: Post-intervention (6-8 weeks post baseline)
Symptoms of Depression
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.
Time frame: Post-intervention (6-8 weeks post baseline)
Population: 11/13 participants completed the post-intervention CES-D survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Symptoms of Depression | 16 score on a scale | Standard Deviation 9.27 |
Symptoms of Depression
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Symptoms of Depression | 22.15 score on a scale | Standard Deviation 13.08 |
Therapist Fidelity
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Therapist Fidelity | 8.9 score on a scale | Standard Deviation 0.47 |
The Self-Compassion Scale
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
Time frame: Post-intervention (6-8 weeks post baseline)
Population: 10/13 participants completed the post-intervention SCS survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | The Self-Compassion Scale | 3.35 score on a scale | Standard Deviation 0.7 |
The Self-Compassion Scale
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
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | The Self-Compassion Scale | 3.06 score on a scale | Standard Deviation 0.7 |
Well-being
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Well-being | 12.23 score on a scale | Standard Deviation 4.25 |
Well-being
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.
Time frame: Post-intervention (6-8 weeks post baseline)
Population: 9/13 participants complete the WHO post-intervention survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Well-being | 15 score on a scale | Standard Deviation 4.27 |