MASC: Reducing Stress for Caregivers

Dementia Alzheimers Clinical Trial

— MASC  

Official title:

The Mindful and Self-Compassionate Care Program Aim 2

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05847153
• Other study ID #: 2023P001130
• Secondary ID: 1R01AG078204-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 12, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: June 30, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer Disease and Related Dementias
• Dementia
• Dementia Alzheimers

Intervention

Behavioral:
• MASC
The intervention arm will be comprised of: Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (11)

Al-Refae M, Al-Refae A, Munroe M, Sardella NA, Ferrari M. A Self-Compassion and Mindfulness-Based Cognitive Mobile Intervention (Serene) for Depression, Anxiety, and Stress: Promoting Adaptive Emotional Regulation and Wisdom. Front Psychol. 2021 Mar 22;12:648087. doi: 10.3389/fpsyg.2021.648087. eCollection 2021. — View Citation

Alsubaie M, Abbott R, Dunn B, Dickens C, Keil TF, Henley W, Kuyken W. Mechanisms of action in mindfulness-based cognitive therapy (MBCT) and mindfulness-based stress reduction (MBSR) in people with physical and/or psychological conditions: A systematic review. Clin Psychol Rev. 2017 Jul;55:74-91. doi: 10.1016/j.cpr.2017.04.008. Epub 2017 Apr 23. — View Citation

Brodaty H, Donkin M. Family caregivers of people with dementia. Dialogues Clin Neurosci. 2009;11(2):217-28. doi: 10.31887/DCNS.2009.11.2/hbrodaty. — View Citation

Conversano C, Orru G, Pozza A, Miccoli M, Ciacchini R, Marchi L, Gemignani A. Is Mindfulness-Based Stress Reduction Effective for People with Hypertension? A Systematic Review and Meta-Analysis of 30 Years of Evidence. Int J Environ Res Public Health. 2021 Mar 11;18(6):2882. doi: 10.3390/ijerph18062882. — View Citation

Jennings LA, Reuben DB, Evertson LC, Serrano KS, Ercoli L, Grill J, Chodosh J, Tan Z, Wenger NS. Unmet needs of caregivers of individuals referred to a dementia care program. J Am Geriatr Soc. 2015 Feb;63(2):282-9. doi: 10.1111/jgs.13251. — View Citation

Jutkowitz E, Kane RL, Gaugler JE, MacLehose RF, Dowd B, Kuntz KM. Societal and Family Lifetime Cost of Dementia: Implications for Policy. J Am Geriatr Soc. 2017 Oct;65(10):2169-2175. doi: 10.1111/jgs.15043. Epub 2017 Aug 17. — View Citation

Lancaster GA. Pilot and feasibility studies come of age! Pilot Feasibility Stud. 2015;1(1):1. doi: 10.1186/2055-5784-1-1. Epub 2015 Jan 12. — View Citation

Mahaffey BL, Mackin DM, Vranceanu AM, Lofaro L, Bromet EJ, Luft BJ, Gonzalez A. The Stony Brook Health Enhancement Program: The development of an active control condition for mind-body interventions. J Health Psychol. 2020 Nov-Dec;25(13-14):2129-2140. doi: 10.1177/1359105318787024. Epub 2018 Jul 16. — View Citation

Pedro J, Monteiro-Reis S, Carvalho-Maia C, Henrique R, Jeronimo C, Silva ER. Evidence of psychological and biological effects of structured Mindfulness-Based Interventions for cancer patients and survivors: A meta-review. Psychooncology. 2021 Nov;30(11):1836-1848. doi: 10.1002/pon.5771. Epub 2021 Jul 28. — View Citation

Roche V. The hidden patient: addressing the caregiver. Am J Med Sci. 2009 Mar;337(3):199-204. doi: 10.1097/MAJ.0b013e31818b114d. — View Citation

Sorensen S, Conwell Y. Issues in dementia caregiving: effects on mental and physical health, intervention strategies, and research needs. Am J Geriatr Psychiatry. 2011 Jun;19(6):491-6. doi: 10.1097/JGP.0b013e31821c0e6e. No abstract available. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Baseline
Other	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.	Post-intervention (6-8 weeks post baseline)
Other	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.	Baseline
Other	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.	Post-intervention (6-8 weeks post baseline)
Other	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.	Baseline
Other	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.	Post-intervention (6-8 weeks post baseline)
Other	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).	Baseline
Other	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).	Post-intervention (6-8 weeks post baseline)
Other	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	Baseline
Other	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	Post-intervention (6-8 weeks post baseline)
Other	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.	Baseline
Other	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.	Post-intervention (6-8 weeks post baseline)
Other	Caregiver self-efficacy	The Revised Caregiver Self-efficacy assess domains of self-efficacy including obtaining respite, responding to disruptive patient behaviors and controlling upsetting through. The Caregiver Self-Efficacy Scale is an 8-item scale with possible scores ranging from 1 to 10 with higher scores indicating higher self-efficacy.	Baseline
Other	Caregiver self-efficacy	The Revised Caregiver Self-efficacy assess domains of self-efficacy including obtaining respite, responding to disruptive patient behaviors and controlling upsetting through. The Caregiver Self-Efficacy Scale is an 8-item scale with possible scores ranging from 1 to 10 with higher scores indicating higher self-efficacy.	Post-intervention (6-8 weeks post baseline)
Other	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".	Baseline
Other	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".	Post-intervention (6-8 weeks post baseline)
Other	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".; Scores range from 4-16.	Baseline
Other	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".; Scores range from 4-16.	Post-intervention (6-8 weeks post baseline)
Other	Well-being	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. To obtain a percentage score ranging from 0 to 100, the raw score is multiplied by 4. A percentage score of 0 represents worst possible, whereas a score of 100 represents best possible quality of life.	Baseline
Other	Well-being	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. To obtain a percentage score ranging from 0 to 100, the raw score is multiplied by 4. A percentage score of 0 represents worst possible, whereas a score of 100 represents best possible quality of life.	Post-intervention (6-8 weeks post baseline)
Other	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)	Baseline
Other	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)	Post-intervention (6-8 weeks post baseline)
Other	Satisfaction with the Intervention	The investigators will use the Client Satisfaction Questionnaire (CSQ-3) to assess participants' satisfaction with the intervention.	Post-intervention (6-8 weeks post baseline)
Other	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 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".	Post-intervention (6-8 weeks post baseline)
Other	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). Benchmark: >=75% of MASC sessions components delivered as intended; 20% sessions rated.	Baseline through Post-intervention (6-8 weeks post baseline)
Other	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.	Post-intervention (6-8 weeks post baseline)
Other	Adherence to Home Practice	The investigators will report proportion of participants who complete weekly home practice.	Weekly (up to 6 weeks)
Other	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?"	Post-intervention (6-8 weeks post baseline)
Other	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.	Baseline
Other	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. The investigators suggest that the AMPS process measure be administered one or more times during the course of the intervention when the participant has become familiar with the practice (for example, at a program mid-point and conclusion). 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.	Baseline
Other	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. The investigators suggest that the AMPS process measure be administered one or more times during the course of the intervention when the participant has become familiar with the practice (for example, at a program mid-point and conclusion). 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.	Post-intervention (6-8 weeks post baseline)
Other	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.	Post-intervention (6-8 weeks post baseline)
Other	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 5 to 30 with higher scores indicating better relationship quality.	Baseline
Other	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 5 to 30 with higher scores indicating better relationship quality.	Post-intervention (6-8 weeks post baseline)
Primary	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)	Baseline
Primary	Feasibility of Assessments	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.	Baseline
Primary	Feasibility of Assessments	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.	Post-intervention (6-8 weeks post baseline)
Primary	Feasibility of Quantitative Measures	The investigators will assess the feasibility of the quantitative measures sent to participants. Benchmark: No questionnaires missing fully in =25% participants.	Baseline
Primary	Feasibility of Quantitative Measures	The investigators will assess the feasibility of the quantitative measures sent to participants. Benchmark: No questionnaires missing fully in =25% participants.	Post-intervention (6-8 weeks post baseline)