Remotely delivered mindfulness-based cognitive therapy for spontaneous coronary artery dissection survivors

Abstract

Background:

After spontaneous coronary artery dissection (SCAD), 80% of survivor’s experience fear of recurrence (FOR) which contributes to poorer clinical outcomes. Although FOR interventions (i.e. mindfulness-based cognitive therapy; MBCT) exist, none have been targeted to SCAD survivors.

Purpose:

To assess the feasibility, acceptability, and preliminary FOR effects of MBCT for SCAD survivors (UpBeat-MBCT).

Methods:

In this single-arm feasibility study, SCAD survivors were recruited from a hospital clinic to participate in UpBeat-MBCT, an 8-week group intervention combining cognitive-behavioral therapy, mindfulness meditation, and health behavior promotion. Participants completed surveys of psychological and behavioral variables pre–post intervention, actigraphy, and daily diaries of sleep and physical activity for 7 days pre–post intervention. The primary outcomes were feasibility and acceptability. Exploratory outcomes included changes in psychological and behavioral variables.

Results:

SCAD survivors (N = 19) were enrolled across two sequential group cohorts (94% female, 95% non-Hispanic White, M_age = 51). In Cohort 1, results indicated that hearing about SCAD from others was emotionally activating and associated with high attrition (33% retained). Refinements for Cohort 2 included placing boundaries around group discussion, and 90% of participants were retained. Among retained participants across both cohorts (n = 12), program satisfaction was M = 8.3/10 (SD = 1.8), 91% (10/11) would recommend the program, and changes in FOR showed a medium-large effect size for improvement (d = 0.72).

Conclusion:

UpBeat-MBCT is the first FOR intervention for SCAD survivors. When boundaries are set to guide discussion of SCAD, results support the feasibility, acceptability, and benefits of an MBCT group approach and the need for expanded testing.

Clinical Trial information:

The Clinical Trials Registration #: NCT04983680.

Lay Summary

After spontaneous coronary artery dissection (SCAD), survivors often experience fear of recurrence (FOR) which can contribute to poorer cardiovascular health outcomes by interfering with sleep and physical activity. This study explores the feasibility, acceptability, and potential benefits of adapted mindfulness-based cognitive therapy (MBCT) for SCAD survivors (UpBeat-MBCT). UpBeat-MBCT is an 8-week group intervention, delivered via videoconferencing, which includes mindfulness meditation, cognitive behavioral therapy skills, and health behavior promotion. Nineteen SCAD survivors participated in the intervention across two sequential groups. Measures of FOR, sleep, and physical activity were collected via surveys, actigraphy, and daily diaries before and after the intervention. Some participants in the first group reported that hearing about other patient’s SCAD experience was emotionally activating, so boundaries around group conversations were established between the first and second groups. Feasibility and acceptability ratings were improved in the second group. Overall, 12 participants completed the intervention and reported high satisfaction with the program and improvements in FOR. These results may suggest that MBCT can be helpful for SCAD survivors when proper boundaries are set around group discussion of SCAD.

Background

Spontaneous coronary artery dissection (SCAD) is a highly impactful yet understudied cause of acute coronary syndromes. SCAD involves the sudden separation of layers of a coronary artery wall, leading to obstructed coronary blood flow and subsequent myocardial infarction and associated complications of myocardial ischemia (including, rarely, sudden cardiac death) [1]. SCAD survivors are unique in that SCAD primarily affects healthy and relatively young women with no cardiovascular risk factors [2], accounting for up to 40% of cardiac events in women under 50 years old [1]. For example, as compared to acute coronary syndrome survivors, SCAD survivors are more likely to be women, younger, have lower body mass index, have lower rates of diabetes and hypercholesterolemia, and have higher rates of anxiety or mood disorders [3]. While the recurrence rate appears to be decreasing, the 5-year SCAD recurrence rate has been reported as high as 30% and there are few established predictors of individual-level recurrence risk [4, 5]. Given the unpredictable onset, disease course, limited secondary prevention options, and unique sociodemographic and clinical characteristics, SCAD survivors experience significant fears of recurrence (FOR) [6, 7]. In a recent survey study of 310 SCAD survivors, 81% reported worry about having another SCAD [8]—rates higher than FOR in populations of other cardiac event survivors and cancer survivors [7].

Elevated FOR is associated with poor cardioprotective health behaviors including poor sleep [9] and physical inactivity [10]. In turn, physical inactivity and sleep disturbance further increase the risk of future cardiac events [11–13]. Interoceptive bias and intolerance of uncertainty are key processes contributing to the relationship between FOR and poor health behaviors. Interoceptive bias involves selective attention and negative evaluation of physical sensations (e.g. overly focusing on sensations in the chest and labeling them as signs of a heart attack [14]). Intolerance of uncertainty refers to difficulty tolerating fears of the unknown (e.g. feeling overwhelmed and making negative assumptions to resolve uncertainty [15]). These processes lead survivors to frequently scan the body for physical sensations, catastrophically evaluate sensations as signs of recurrence, and experience heightened distress about possible recurrence [16]. These processes increase FOR severity, creating ongoing hyperarousal that maintains activation of the sympathetic nervous system and dysregulates sleep [17]. Fears of physical sensations induced by exercise, and uncertainty about whether exercise may trigger recurrence, lead to avoidance of physical activity, contributing to poorer physical health and increasing the risk of future recurrence or disease progression [1, 6, 18]. Effective FOR treatments must target interoceptive bias and intolerance of uncertainty in order to reduce FOR severity and improve sleep and physical activity. Additionally, feasible ways to objectively assess sleep and physical activity in remote trials (e.g. actigraphy) must be established and supported.

A scientific statement from the American Heart Association identified a need for interventions to improve outcomes after SCAD [2], but to our knowledge, there have been no FOR interventions developed and tested in SCAD survivors. Mindfulness-based cognitive therapy (MBCT [19]) is an evidence-based group intervention that targets interoceptive bias and intolerance of uncertainty, and has evidence of feasibility and efficacy to improve fear of cancer recurrence [20, 21], sleep [22], and physical activity in cancer survivors [23]. MBCT is typically an 8-week group intervention that combines mindfulness meditation and cognitive-behavioral therapy to teach nonjudgmental awareness and self-regulation of attention toward the present moment [19]. Key components include mindfulness meditation (e.g. body scan, awareness of breath meditation) and cognitive-behavioral interventions (e.g. the ABC model [24], automatic thought patterns [25]). While MBCT has been tested in other cardiac populations, no research has tested MBCT among SCAD survivors.

Figure 1 explicates how the mechanisms of action in MBCT target interoceptive bias and intolerance of uncertainty to reduce FOR severity and, thereby, improve sleep and physical activity. For example, the body scan involves slowly moving attention throughout the body to directly feel, rather than judge, physical sensations, thereby training skills in nonjudgmental body awareness and attention regulation. Breath meditation involves focusing attention on the breath while noticing and letting go of thoughts, which trains the skill of cognitive decentering. These meditation skills reduce interoceptive bias by helping survivors notice physical sensations without catastrophic judgment, notice the way the sensations naturally change over time, and shift attention to something else in the moment (e.g. other nonfear-activating body sensations). The ability to regulate attention toward the present moment can also interrupt future-oriented thinking that contributes to intolerance of uncertainty. Given that SCAD survivors struggle with distrust in their bodies [26], meditation practices may rebuild trust by bringing awareness to body parts that feel safe or neutral and noticing positive bodily changes. Cognitive-behavioral skills in MBCT help patients identify unhelpful thought patterns, learn that thoughts are not facts, and disengage from catastrophic thoughts (i.e. cognitive decentering [27]). Please see our prior publication detailing an evidence-based conceptual model of how MBCT targets FOR [16].

Figure 1.

Conceptual model of UpBeat-MBCT to target FOR in SCAD survivors. Note. Plus signs indicate increases and minus signs indicated decreases in the variable.

In our prior study (NCT04799899), we adapted MBCT to target the needs of acute cardiac event survivors [28] using the ORBIT model for behavioral intervention development [29]. The adapted intervention (named UpBeat-MBCT) was developed to target depression symptoms after an acute cardiac event through qualitative interviews with 22 cardiac event survivors, primarily men who survived myocardial infarction or unstable angina. Results revealed a multitude of quality of life concerns including FOR, sleep problems, and physical inactivity. UpBeat-MBCT aims to target these concerns [28]. Given the cardiac patient-informed adaptations and transdiagnostic mechanisms of action, UpBeat-MBCT is hypothesized to be feasible, acceptable, and to improve FOR and health behaviors for SCAD survivors. At the same time, due to the unique sociodemographic and medical characteristics of SCAD, there are likely ways to refine the intervention to optimize relevance and benefits for this unique population.

The primary aims of this single-arm open pilot study were to explore feasibility and acceptability of (i) UpBeat-MBCT for SCAD survivors, and (ii) research procedures including enrollment and retention of SCAD survivors, and completion of surveys, actigraphy, and daily diaries. We hypothesize that (i) the intervention will be feasible (evidenced by enrollment, retention, and attendance rates) and acceptable (evidenced by intervention satisfaction ratings and exit interview findings); and (ii) research procedures will be feasible (evidenced by completion rates) and acceptable (evidenced by ease of completion). Specific feasibility and acceptability benchmarks were set a priori and are described in the results section. The exploratory aims are to explore (i) changes in psychological variables including FOR severity; UpBeat-MBCT mechanisms (nonjudgmental body awareness, attention regulation, cognitive decentering, distress tolerance); and FOR processes (interoceptive bias, intolerance of uncertainty); and (ii) changes in behavioral variables (sleep outcomes and physical activity). We hypothesize that participants will report improvements in each variable.

Methods

Participants and recruitment

This study was funded by an NIA P90 award through the Columbia Roybal Center for Fearless Behavior Change (NCT04983680). Participants were SCAD survivors recruited from Massachusetts General Hospital through hospital flyers and cardiologists’ referrals. Treating cardiologists provided patients with the study flyer (via email or in person) or obtained verbal permission to email the patients’ information to the study team. Interested patients were screened for eligibility over the phone by the study research assistant (RA), who was Collaborative Institutional Training Initiative-certified and trained in all research procedures.

Inclusion criteria changed between the first and second intervention cohort based on lessons learned (described in detail in the Results section). In Cohort 1, inclusion criteria were: (i) adults aged 18 or older; (ii) cardiologist-confirmed diagnosis of SCAD in the past 1–12 months; (iii) English speaking; (iv) access to reliable internet connection (via computer or mobile device). Exclusion criteria included: (i) terminal illness with life expectancy <1 year; (ii) severe mental illness requiring urgent psychiatric intervention or past-year psychiatric hospitalization; (iii) significant cognitive impairment preventing informed consent; (iv) deemed unable to complete research procedures by study staff clinical judgment; or (v) unavailable for intervention sessions (e.g. schedule conflicts). In Cohort 2, the inclusion criteria for SCAD diagnosis changed to SCAD in the past 3–18 months; all other eligibility criteria remained the same.

Although SCAD primarily affects women, survivors of all sexes and gender identities were eligible. We did not include an eligibility criterion for baseline FOR severity given the exploratory nature of the study and expectation that those who choose to enroll are likely to be struggling with distressing levels of FOR. Eligible and interested patients completed informed written e-consent with the trained RA via a secure online data collection system (REDCap). Recruitment and data collection procedures were approved by the institutional review board and followed the Health Information Privacy and Accountability Act (HIPAA).

Study design

This study was a single-arm, proof-of-concept pilot with two sequential intervention cohorts. This approach was guided by the ORBIT model for behavioral intervention development, a framework for adapting behavioral interventions to specific patient populations using a flexible, iterative approach [29]. The current study reflects ORBIT Phase IIa (“proof-of-concept”) [29]. Since this was the first delivery of UpBeat-MBCT for SCAD, we expected a need for refinements. The ORBIT model encourages ongoing evaluation and iterative refinement by returning to earlier stages of development (e.g. Stage Ib, “refine”). We therefore delivered two sequential interventions cohorts so we could review the outcomes of the first cohort and make refinements for the second cohort. To define feasibility and acceptability outcomes, we used established guidelines [30].

All participants were identified using a study ID. Results from Cohort 1 were used to inform refinements to the intervention and research procedures for Cohort 2. Participants completed pre- and postintervention surveys of psychological and behavioral variables 1 week before and after the 8-week intervention, and daily diaries for 1–2 weeks before and after the intervention, via REDCap. Participants also completed actigraphy each day for 1–2 weeks before and after the intervention using the Actiwatch, a wearable device that continuously assesses sleep and physical activity patterns. Daily diaries and actigraphy were collected for 1–2 weeks to provide flexibility to aim for 7 consecutive days of data collection. Upon completion of the intervention, participants completed an audio- or video-recorded exit interview (approximately 30 minutes), in which a trained RA used a semistructured interview guide to assess perceptions of the intervention. The purpose of the exit interviews was to assess intervention acceptability and perceived changes in FOR and health behaviors. Participants were asked directly what they liked and disliked about the program, and what changes they noticed regarding FOR, sleep, and physical activity since participating in the program. All interviews were recorded and transcribed for analysis. Figure 2 depicts the study design.

Figure 2.

Open pilot study design.

Intervention delivery

The intervention delivered in the current study was UpBeat-MBCT, our adaptation of the MBCT protocol, designed to address the needs of acute cardiac event survivors. In its standard protocol, MBCT typically involves 8 weekly 2.25-hour group sessions focused on mindfulness meditation training and cognitive-behavioral therapy skills [19]. Adaptations for UpBeat-MBCT were previously made based on the results of our qualitative research study of acute coronary syndrome survivors [28]. Table 1 provides an overview of UpBeat-MBCT and its differences from standard MBCT. Examples of adaptations include shorter session duration and home practice recommendations, inclusion of health behavior promotion, and linking mindfulness skills to FOR and social support after a cardiac event.

Table 1.

Overview of the UpBeat-MBCT Intervention Content

Session & Theme	Standard MBCT	UpBeat-MBCT	Rationale for Adaptations
1. Awareness and automatic pilot	• Raisin exercise • Body scan	• Raisin exercise • *Compassionate body scan • *Rationale for mindfulness after cardiac event	• Enhance ease of body scan by inviting gratitude and positive affect toward the body • Build treatment motivation
2. Living in our heads	• Body scan • Walking down the street exercise (ABC model) • Mindfulness of breath	• *Awareness of breath meditation • Walking down the street exercise • *Nourishing-draining exercise • Mindfulness of breath	• Introduce awareness of breath meditation to make space for added meditation in later sessions • Complete nourishing-draining activity at the start to address low mood and increase engagement
3. Gathering the scattered mind	• Sitting meditation • Pleasant events calendar review • Territory of depression • 3-minute breathing space • Mindful stretching	• Sitting meditation • Pleasant experiences calendar • *Linked pleasant experiences to appreciations after cardiac event • *Psychoeducation of emotions after cardiac event (e.g., sadness, anxiety, guilt, anger) • 3-minute breathing space • Mindful stretching	• Enhance relevance of pleasant events to cardiac event survivors • Address the range of emotions cardiac event survivors experience
4. Recognizing aversion	• Sitting meditation • Unpleasant events calendar review • Depressive automatic thoughts questionnaire • 3-minute breathing space-responsive • Mindful walking	• Sitting meditation • Unpleasant experiences calendar • *Linked unpleasant experiences to challenges after cardiac event • *Unhelpful thought patterns (cognitive distortions) • 3-minute breathing space • Mindful walking	• Enhance relevance to unpleasant events to cardiac event survivors • Address the types of thought patterns relevant to across emotions
5. Allowing/letting be	• Sitting with difficulty meditation • 3-minute breathing space- expanded • Midway reflection	• Sitting with difficulty meditation • 3-min. breathing space- expanded • Midway reflection • *Psychoeducation of mindfulness and cardiac health behaviors	• Build motivation and skills for making health behavior changes (e.g., sleep, physical activity, diet)
6. Thoughts are not facts	• Sitting meditation • Moods, thoughts, alternative viewpoints • Relapse signature • 3-minute breathing space	• Sitting meditation • Alternative viewpoints • Relapse signature • 3-min. breathing space • *Fear of recurrence	• Provide psychoeducation, normalization, and skills for coping with FOR
7. How can I best take care of myself	• Sitting meditation • Nourishing-draining exercise • Activity scheduling/planning • Responding wisely to distress • 3-minute breathing space	• *Loving kindness meditation • Responding wisely to distress • Activity planning • 3-min. breathing space • *Psychoeducation about mindfulness and social support	• Include loving kindness meditation to address guilt and self-blame • Build motivation and skills for effectively utilizing social support after a cardiac event
8. Maintaining and extending new learning	• Body scan • Course review • Keeping up momentum • Concluding meditation	• Body scan • Course review • Keeping up momentum • *Planning for ongoing cardiac health behaviors • *Concluding meditation (Love after Love by Derek Walcott)	• Plan for ongoing engagement in health behaviors • Close with a poem that conveys self-care and acknowledges the heart

Note. UpBeat-MBCT adaptations based on our qualitative study (Luberto et al., 2024) are indicated in italics. Each session of MBCT and UpBeat-MBCT also include group discussion of past-week home practice.

The UpBeat-MBCT intervention involved 8 weekly group sessions delivered via synchronous group videoconferencing, and included mindfulness meditation training, cognitive behavioral therapy skills, and cardiac health behavior promotion. Each session was 1.5 hours except for the first session which was 2 hours. Health behavior promotion was emphasized in session 1 using the extra time, and included health behavior guidelines (e.g. sleep hygiene, “eating the rainbow”) and setting SMART goals. In subsequent sessions, all standard MBCT meditations and cognitive-behavioral therapy content were retained, and health behavior promotion was integrated by encouraging patients to set health behavior goals and discuss how lessons learned from meditation might apply to health goals. Psychoeducation of FOR and how mindfulness can reduce FOR was discussed. For social support, we provided psychoeducation of the importance of social support after a cardiac event, types of social support, and strategies for mindful interpersonal interactions. Participants were encouraged to practice 15–20 minutes of daily formal mindfulness practice between sessions (as compared to 40 minutes of home practice in standard MBCT). Participants were provided digital guided meditation recordings to aid in their home practice. Supplementary Appendix A details UpBeat-MBCT according to the Template for Intervention Description and Replication (TIDiER) checklist [31].

The intervention was delivered by the first author (C.M.L.), a licensed clinical psychologist with over 10 years of experience delivering MBCT in clinical and research settings to patients with emotional and physical health conditions including cardiovascular disease. She was trained according to established MBCT training requirements including participation in formal workshops, participation and observation of MBCT groups, and coleading 5–10 groups with supervised mentorship [32]. She regularly participates in continuing education training of MBCT and maintains a personal mindfulness practice.

Measures

The primary outcomes were feasibility and acceptability of the intervention and research procedures. Specific benchmarks were set for each feasibility and acceptability outcome and are detailed in the results section.

Exploratory outcomes were changes in psychological and behavioral variables reflected in our conceptual model (Fig. 1) and were measured via pre- and postintervention surveys, as well as daily diaries and actigraphy for 1–2 weeks before and after the intervention. All measures were validated self-report measures and included the Assessment of Survivor Concerns (ASC; FOR [33]), Multidimensional Assessment of Interoceptive Awareness (MAIA; body listening and body trusting subscales [34]), Cognitive and Affective Mindfulness Scale-Revised (CAMS-R; mindful attention regulation [35]), Experiences Questionnaire-Decentering Subscale (EQ; cognitive decentering [36]), Distress Tolerance Scale (DTS; distress tolerance [37]), Body Vigilance Scale (BVS; interoceptive bias [38]), Intolerance of Uncertainty (IUS-12; ability to withstand uncertainty [15]), Consensus Sleep Diary [39], and Physical Activity Vital Sign (PAVS) [40]. Daily diaries collected the psychological variables and self-reported physical activity at night, and sleep outcomes in the morning. To reduce participant burden, daily diaries used only one item from each of these measures. We selected the item that had the highest factor loading from the measure’s initial validation study.

The postintervention survey included a feedback questionnaire. This questionnaire assessed intervention acceptability in terms of satisfaction (1 = not at all satisfied to 10 = very satisfied), plans to continue using skills (yes or no), and if they would recommend the intervention to others (yes or no). We assessed acceptability of research methods including ease of completing daily diaries (1 = not at all easy to 10 = very easy), daily diary interference (1 = not at all to 10 = very much), and ease of wearing the actigraphy watch (1 = not at all easy to 10 = very easy). The survey also asked how much participants practiced mindfulness throughout the intervention (daily or almost daily, a few times/week, once or twice/week, never).

To ensure intervention fidelity, sessions were audio- and video-recorded and a trained RA completed the MBCT adherence scale (MBCT-AS) [41].

Data analysis

Quantitative

To assess primary feasibility and acceptability outcomes, frequencies, proportions, and measures of central tendency (means/standard deviations) were calculated. For exploratory psychological and behavioral outcomes, we examined means and standard deviations on the pre- and postintervention surveys and explored changes in each variable using paired samples t-tests. Given that this is a small pilot feasibility study, and these are exploratory analyses, we conducted completer analyses and emphasize Cohen’s d as an estimate of within-group effect size (0.3 = small, 0.5 = medium, 0.8 = large) [42]. Daily diary and actigraphy data are not reported here and will be presented in a future manuscript. To assess treatment fidelity, a trained RA with experience observing MBCT groups reviewed a random 20% of intervention sessions and rated fidelity using the MBCT-AS [41]. Intervention sessions were considered to have met fidelity if the RA’s score was ≥80% of the total score (≥23 out of 28).

Qualitative

Exit interviews were audio recorded, transcribed, and iteratively analyzed using deductive content analysis to fit the data into categories. Specifically, we coded participants’ responses to interview questions regarding intervention likes and dislikes and health changes. Two trained RAs conducted an initial review of all transcripts to familiarize themselves with the interview content and themes. The same RAs then separately created coding frameworks based on interview questions and a thorough reading of half of the transcripts. Under supervision from the PI, the RAs met regularly to discuss and reconcile discrepancies and combine the coding frameworks. Once an initial coding framework was agreed upon, the remaining transcripts were split between the two RAs to be coded. There was iterative refinement of the codebook as additional transcripts were reviewed. Once a final framework was created, all transcripts were coded accordingly, and relevant quotes were pulled for each thematic group. No statistical software was used for coding or analyzing qualitative data.

Results

Participants

Participant characteristics are presented in Table 2. On average, participants (N = 19) were 51 years old (SD = 9.5), White (95%), and female (94%), and had their SCAD event 7.25 months ago (SD = 5.77; range = 1–18 months). There were n = 9 participants in Cohort 1 and n = 10 in Cohort 2. Cohort 1 ran from 30 November 2021 to 18 January 2022. Cohort 2 ran from 29 March 2022 to 24 May 2022. Figure 3 depicts the study CONSORT.

Table 2.

Sample characteristics

	Cohort 1 (n = 9)	Cohort 2 (n = 10)
Age in years, M (SD)	52 (8.6)	49.5 (10.5)
Gender, N (%)
Male	0 (0%)	1 (11.1%)
Female	8 (100%)	8 (88.9%)
Months since SCAD, M (SD)	4.33 (4.18)	11.0 (5.54)
More than 1 SCAD event, N (%)	3 (33%)	2 (20%)
Race: White, N (%)	9 (100%)	9 (90%)
Ethnicity: Non-Hispanic ethnicity, N (%)	9 (100%)	10 (100%)
Marital Status, N (%)
Married/living together	5 (55.6%)	9 (90%)
Divorced/Separated/Widowed	4 (44.4%)	0 (0%)
Never married	0 (0%)	1 (10%)
Education, N (%)
Some college	2 (22.2%)	5 (50%)
Completed college	5 (55.6%)	3 (30%)
Advanced degree	2 (22.2%)	2 (20%)
Employment, N (%)
Employed full time	6 (75.0%)	4 (44.4%)
Employed part time	1 (11.1%)	1 (11.1%)
Retired	0 (0%)	1 (11.1%)
On disability	0 (0%)	2 (22.2%)
Other	1 (11.1%)	1 (11.1%)

Note. Data were missing for gender (n = 2),employment (n = 2), and months since SCAD (n = 3). Valid percents are reported.

Figure 3.

Study CONSORT.

Feasibility and acceptability outcomes

Feasibility and acceptability outcomes are reported for the full sample and separately by cohort. Table 3 outlines feasibility benchmarks and results, and Table 4 outlines acceptability benchmarks and results.

Table 3.

Primary Feasibility Outcomes

Feasibility Outcome	Feasibility Benchmark	Cohort 1 (n=9)	Cohort 2 (n=10)	Full Sample (n=19)
Enrollment, N (%)	≥70% eligible enroll	9/10 (90%)	10/10 (100%)	19/20 (95%)
Retention1, N (%)	<20% attrition	3/9 (33%)	9/10 (90%)	12/19 (63%)
Baseline Survey, N (%)	≥70% completion	9/9 (100%)	10/10 (100%)	19/19 (100%)
Pre-Intervention Daily Diaries, N (%)	≥70% completed for 7 consecutive days	5/9 (55%)	8/10 (80%)	13/19 (68%)
Pre-Intervention Actigraphy, N (%)	≥70% completed for 7 consecutive days	9/9 (100%)	10/10 (100%)	19/19 (100%)
Intervention Completion, N (%)	≥70% attended 6/8 sessions	3/9 (33%)	7/10 (70%)	10/19 (53%)
Post-Intervention Survey, N (%)	≥70% completion	3/9 (33%)	9/10 (90%)	12/19 (62%)
Post-Intervention Daily Diaries, N (%)	≥70% completed for 7 consecutive days	1/9 (11%)	6/10 (60%)	7/19 (36%)
Post-Intervention Actigraphy, N (%)	≥70% completed for 7 consecutive days	4/9 (44%)	9/10 (90%)	13/19 (68%)

Note.

¹Retention is defined as completing the post intervention survey.

Table 4.

Primary Acceptability Outcomes

Acceptability Outcome	Acceptability Benchmark	Cohort 1 (n=3)	Cohort 2 (n=8)	Full Sample (n=11)
Intervention Acceptability
Overall Satisfaction, M, (SD) and N	≥7 average satisfaction rating	7.33 (3.06)	8.63 (1.30)	8.27 (1.85)
Plan to continue using the skills, N (%)	≥70% plan to continue use	3/3 (100%)	8/8 (100%)	11/11 (100%)
Recommend to other SCAD survivors, N (%)	≥70% positive recommendation	2/3 (67%)	8/8 (100%)	10/11 (91%)
Research Methods Acceptability
Ease of completing daily diary, M (SD)	≥7 average ease rating	6.33 (3.22)	8.33 (1.73)	7.83 (2.21)
Daily diaries interfered with their day, M (SD)	≤2 average interference rating	3.33 (2.08)	2.89 (2.85)	3.00 (2.59)
Ease of actigraphy, M (SD)	≥7 mean ease rating	8.67 (1.16)	8.67 (2.60)	8.67 (2.27)

Note. Data were missing for plan to continue using skills (n=11) and recommend to other SCAD survivors (n=11). Valid percents are reported.

Cohort 1: Feasibility

Recruitment and retention:

Recruitment goals were met in five weeks. Of N = 12 participants screened, 83% (10/12) were eligible. 90% (9/10) of eligible patients were consented (one participant lost to follow-up). There was a 33% (3/9) retention rate on the postintervention survey (two participants withdrew, four lost to follow-up). Fifty-five percent (5/9) of participants completed the preintervention daily diaries for 7 consecutive days, and 11% (1/9) completed the postintervention daily diaries for 7 consecutive days. 100% (9/9) completed preintervention actigraphy for 7 consecutive days, and 44% (4/9) completed postintervention actigraphy for seven consecutive days. Thirty-three percent (3/9) attended ≥6/8 intervention sessions.

Cohort 1: Acceptability

Intervention acceptability:

Among those retained at postintervention (n = 3), the average intervention acceptability rating was M = 7.33/10 (SD = 3.06), and 100% (3/3) of participants indicated that they plan to continue using the intervention skills. 67% (2/3) of participants indicated they would recommend the program to other SCAD survivors.

Research methods acceptability:

The average score for ease of completing daily diaries was M = 6.33/10 (SD = 3.22) and interference of daily diaries was M = 3.33/10 (SD = 2.08). Average ease of actigraphy use was M = 8.67/10 (SD = 1.16).

Intervention modifications between cohorts

We conducted a preliminary analysis of Cohort 1 exit interviews and feasibility results, and clinical observations from the intervention sessions. We made several refinements based on these results including setting boundaries around group discussion, providing hope for emotional coping, clarifying expectations for participant diversity, and revising the eligibility criteria (Table 5). No changes were made to the UpBeat-MBCT content components.

Table 5.

Modifications Made Between Cohort 1 and Cohort 2

Intervention Modification	Rationale
Set boundaries to reduce oversharing about SCAD	Interventionist’s observation: Participants reported increased anxiety during session 1 when hearing about others’ SCAD history Cohort 1 result: Low retention (3/9; 33%) with most participants (5/9; 55%) lost after the first two sessions Participant feedback: Hearing about others’ SCAD events was distressing (e.g., “The first two sessions, especially the first one, was challenging because people were truly upset and trying to talk about their own experience.” “Encouraging people let’s not relieve your SCAD attacks.”)
Provided hope for UpBeat-MBCT as a mental health program to assist with emotional coping	Interventionist’s observation: Participants expressed anxiety about the medical uncertainty of SCAD and needed help focusing on the emotional coping within their control Participant feedback: Provide reassurance that we can cope (e.g., “Reassure us that you know the first couple meetings might be a little emotional but that’s ok because…we’re going to learn skills that will help us all cope with these kinds of strong emotions.”)
Clarified expectations for participant diversity of SCAD	Interventionist’s observation: Many participants found it challenging to hear about others’ SCAD experiences or recurrences Cohort 1 result: Variability in time since SCAD (M = 4.33 months [SD = 4.18], Range: 1 – 12 months), 33% (3/9) had SCAD recurrence, one adverse event from a participant learning about recurrence Participant feedback: Tell participants that others may have had more than one SCAD (e.g., “Knowing some women have had multiple SCAD attacks, some have only had one”)
Provided more guidance about group zoom	Participant feedback: Some zoom functions were not clear (e.g., “People would end up on the side of the screen…I probably could’ve changed that myself, couldn’t I?”)
Research Modification	Rationale
Revised eligibility criteria: 3–18 months post-SCAD	Interventionist’s observation: Participants closer to the time of their event reported higher distress Cohort 1 result: Many participants (3/9; 33%) were within the first 3 months post-SCAD Participant feedback: More time after SCAD would make the intervention more feasible (e.g., “If [SCAD] is like within 30–60 days it messes with your mind…. Even [having the intervention] 3 or 6 months out when they’ve had time to heal a little and reach out and get other resources”)
Enhanced actigraphy guidance	Participant feedback: Difficulty wearing and/or keeping track of the watch (e.g., “The problem I had at first is that my silly wrist is so skinny I had trouble keeping [the watch] on.” “I immediately thought oh dear what did I do with it? I should’ve sent an email to myself as where I put it.”)
Clarified daily diary expectations	Cohort 1 result: Low daily diary completion at baseline (55%), low ease of daily diary completion (M = 6.33/10) Participant feedback: Difficulty completing daily diaries (e.g., “You have to make sure you do them right at that appropriate time because there’s subtle little things… It would have been nice if somebody gave me a heads up”)

The primary consideration was the high attrition for Cohort 1. In exit interviews, Cohort 1 participants indicated that listening to other participants share their SCAD stories was anxiety provoking, which likely contributed to the high attrition, as most participants were lost after session 1 when participants introduced themselves. Intervention refinements focused on clarifying the intentions and expectations of the group (e.g. skills group rather than support group), and setting boundaries to reduce over-sharing about personal details of SCAD. For example, in Cohort 1, participants introduced themselves by sharing how long ago they had their SCAD and what they hope to get out of the group, which led to over-sharing of emotional distress and medical details of SCAD. Thus, in Cohort 2, we asked participants to share the duration of time since SCAD and one way they are already coping well.

For research refinements, as mentioned earlier, we changed the eligibility criteria from 1- to 3-month post-SCAD to allow more time for emotional recovery and stabilization. Results of Cohort 1 exit interviews, high attrition in Cohort 1, and the interventionist’s clinical observations suggested participants may need more time to process their SCAD event before discussing their emotions in a group and listening to other people’s experiences. One participant in Cohort 1 reported an adverse event of increased distress due to learning about SCAD recurrence. We therefore revised the eligibility criteria from 1- to 3-month post-SCAD with the aim to improve intervention feasibility, acceptability, and patient safety in Cohort 2.

Regarding research modifications, some participants shared that it was difficult to complete the daily diary items because they did not know what to expect, particularly regarding sleep questions, so we provided additional guidance by clarifying the types of questions they would be asked each morning. Given the low adherence to daily diaries, we added feasibility/acceptability items to the postintervention survey to better understand barriers and facilitators (e.g. questions about survey length, frequency, timing, content, and REDCap).

Cohort 2: Feasibility

Recruitment and retention:

Recruitment goals were met in 8 weeks, with a waitlist filled during the Cohort 1 intervention period. Of N = 12 participants screened, 83% (10/12) were eligible, and 100% (10/10) consented. 90% (9/10) of participants were retained postintervention, with only one patient withdrawing (reason unknown). For preintervention daily diaries, 90% (9/10) completed seven consecutive days; for postintervention daily diaries, 60% (6/10) completed 7 consecutive days. One hundred percent (10/10) of participants completed preintervention actigraphy for 7 consecutive days, and 90% (9/10) completed postintervention actigraphy for 7 consecutive days. Seventy percent (7/10) attended ≥6/8 intervention sessions.

Cohort 2: Acceptability

Intervention acceptability:

Intervention satisfaction was M = 8.63 (SD = 1.30; n = 8 as one retained participant did not complete the feedback form). One hundred percent (8/8) indicated they planned to continue using the skills and would recommend the intervention to other SCAD survivors.

Research methods acceptability:

The average ease of completing daily diaries was M = 8.33 (SD = 1.73), and average interference of daily diaries was M = 2.89 (SD = 2.85). Average ratings of ease for actigraphy were M = 8.67 (SD = 2.60).

Home practice adherence across both cohorts

On the postintervention survey, among retained participants (N = 12), 100% (12/12) reported practicing mindfulness at least once or twice a week.

Intervention fidelity across both cohorts

Three sessions were rated by the RA, two (session #5 and #7) from Cohort 1 and one (session #4) from Cohort 2. Sessions reviewed were randomly chosen using a random number generator. All sessions met the fidelity benchmark, scoring 28/28 (100%) on the MBCT-AS.

Changes in psychological and behavioral variables across both cohorts

Scores on pre–post intervention surveys

Among retained participants across both cohorts (N = 12), all psychosocial and behavioral variables except for moderate-vigorous physical activity showed changes in the direction of clinical improvement (Cohen’s d = 0.16–1.03; Table 6). See Supplementary Appendix B for bar charts.

Table 6.

Outcome Measure Scores Pre-Post UpBeat-MBCT

Outcome	Baseline M (SD)	Post-Intervention M (SD)	Test Statistic	Effect Size (95% Confidence Interval)
FOR Outcomes
FOR Severity (ASC, α = .86)1	13.33 (3.50)	11.33 (3.85)	t(11) = −2.48	−.72 (−1.34 – −.064)
Intolerance of Uncertainty (IUS, α = .96)1	33.36 (14.40)	27.64 (12.91)	t(10) = −2.30	−.69 (−1.34 – −.017)
Body Listening (MAIA, α = .90)2	8.10 (4.25)	8.80 (3.91)	t(9) = 0.49	.16 (−.47 – .77)
Body Trusting (MAIA, α = .96)2	8.00 (5.54)	8.70 (4.76)	t(9) = 0.55	.17 (−.47 – .79)
Health Behavior Outcomes
Sleep Efficiency2	76.50 (8.70)	80.33 (8.60)	t(11) = 1.01	.31 (−.31 – .90)
MVPA (minutes/week)2	232.39 (161.20)	212.29 (86.55)	t(12) = −.70	−.20 (−.77 – .37)
Muscle strengthening (days/week)2	1.36 (1.74)	2.73 (1.69)	t(11) = 2.35	.71 (0.29 – 1.36)
MBCT Skills
Mindfulness (CAMS-R, α = .92)2	31.58 (8.74)	32.58 (6.93)	t(11) = 0.63	.18 (−.39 – .75)
Decentering (EQ, α = .91)2	32.91 (10.00)	38.18 (6.52)	t(10) = 3.42	1.03 (.27 – 1.75)
Distress Tolerance (DTS, α = .96)2	3.18 (0.94)	3.38 (0.76)	t(10) = 1.33	.40 (−.22 – 1.01)
Body Vigilance (BVS, α = .74)1	18.25 (5.28)	15.07 (5.14)	t(11) = 2.05	−.59 (−1.20 – .036)

Note. N=12 participants retained across both cohorts.

¹Lower scores indicated better outcomes,

²Higher scores indicate better outcomes. Cronbach’s alpha is presented for each measure at baseline. Cronbach’s alpha is not available for health behavior outcomes as these are single-item outcomes.

Exit interviews findings

Exit interviews assessed participants’ likes and dislikes of the intervention (Quotes are presented in Supplementary Appendix C). Most participants reported liking the session content and skills, specifically the 3-minute Breathing Space (e.g. “Learning more about the meditation, about the three-minute breathing, probably was the most helpful to me”). Most participants also liked the social support of the group format. However, some participants wanted to talk about their SCAD experience, while for others, hearing about others’ SCAD experience was anxiety provoking (e.g. “The unhelpful side was listening to other’s SCAD stories”). Many participants appreciated the convenience of videoconferencing and said they would not have been able to participate in person, though some found participating from home to be distracting due to noises from other household members. A few participants noted that sessions were sometimes stressful to fit into their busy schedule, though some wished the program had gone on longer.

Participants had valuable suggestions for improvement. Some participants wanted smaller groups due to discomfort in larger social settings. A few participants would have preferred an in-person group to increase group rapport. Many participants recommended shortening the home practice recommendations. About half of participants suggested removing or decreasing the daily diaries expectation due to issues with REDCap or the time commitment. About half of participants felt wearing the actigraphy watch was comfortable and easy, though others found it uncomfortable (e.g. didn’t fit well, irritated the skin, not comfortable at night).

Exit interviews also explored health improvements following the program (quotes are presented in Supplementary Appendix D). Almost all participants reported a health-related improvement, with a reduction in FOR being the most common (e.g. “I’m more able to handle my physical symptoms now … I try to deep breathe and think about it … versus just panic”). Participants either emphasized improved coping skills when confronted with chest sensations or a reduced fear chest sensations in general. Positive health behavior changes were reported by many participants, such as improvements in physical activity, or use of mindfulness techniques to improve sleep (e.g. “That’s one of my biggest changes, I have been sleeping better”). For those who did not report improvements in physical activity or sleep, many identified increased contemplation of change or identification of barriers.

Discussion

The purpose of the present study was to assess the feasibility and acceptability of UpBeat-MBCT for SCAD survivors. This study was the first intervention to target FOR in SCAD survivors and one of the first trials of any type of behavioral intervention for SCAD. Results indicated that SCAD survivors are eager to participate in behavioral health treatment and require targeted interventions that address their unique emotional and behavioral health needs. Results highlight the importance of iterative intervention development and testing and demonstrate that careful attention to the unique aspects of SCAD survivorship is needed to make appropriate treatment adaptations and increase intervention feasibility.

Results yielded different feasibility results for the first and second cohorts. During Cohort 1, many patients were lost to follow-up due to the emotional impact of discussing SCAD in the first intervention session. These discussions arose when patients shared what brings them to the group, which is the same introductory question used in our trial of Up-Beat MBCT for traditional acute coronary syndrome survivors, although this discussion was emotionally neutral in ACS survivor groups. We therefore made refinements prior to Cohort 2 that set clearer boundaries around SCAD discussions, and feasibility was significantly improved in Cohort 2. Setting ground rules for discussing emotionally difficult topics may be needed in this group because of preexisting heightened levels of anxiety, depression, and trauma prior to their SCAD, which can become compounded by the traumatic experience, lifestyle limitations, and stressors of having a SCAD event [8, 43–45]. It is worth noting, however, that some participants in Cohort 2 would have liked more discussion of personal SCAD experiences. One approach to balance group safety and personal sharing is to invite more sharing toward the end of the group when participants have developed more coping skills.

Acceptability of the intervention content was high for treatment completers in both cohorts, indicating that UpBeat-MBCT skills and techniques may be useful for SCAD survivors. The telehealth delivery was also feasible and acceptable to most participants, though some found it distracting to participate from home and/or uncomfortable to be on camera. UpBeat-MBCT group leaders can provide guidance to help reduce distractions (e.g. turning off email and other web browsers, participating from a quiet place and asking household members for privacy), and offer gentle encouragement and choice regarding the use of video. In terms of research procedures, feasibility of daily diary research procedures was lower in Cohort 1 but improved in Cohort 2, while actigraphy was generally feasible across both groups.

Exploratory results regarding changes in health outcomes suggest that UpBeat-MBCT is a promising intervention for SCAD survivors. FOR severity scores and FOR mechanisms of intolerance of uncertainty and interoceptive bias all showed medium-large changes in the direction of clinical improvement. In addition, cognitive decentering, a well-established mechanism of action in MBCT [46], showed a large effect size for improvement. These results provide preliminary evidence that, in line with our conceptual model, UpBeat-MBCT may reduce FOR for SCAD survivors by helping them step back from unhelpful thoughts about their body, notice body sensations with less judgment, and tolerate the uncertainty of whether or not a physical symptom may be concerning or whether SCAD will recur in the future. Exit interview themes were consistent with these findings, as patients reported decreased FOR and improved ability to cope with anxious thoughts and physical sensations. These results are consistent with research on MBCT in other medical and psychiatric populations [47–50] and advance this literature by explicating and providing preliminary support for a detailed conceptual model for FOR processes in a novel, underrecognized SCAD population.

The benefits for physical activity were limited. There was no meaningful change in MVPA as measured by the Physical Activity Vital Sign (self-report measure). These findings contrast with the larger literature focused on mindfulness and behavior change [51] including a recent meta-analysis which found that mindfulness interventions are associated with increased physical activity [52]. In our qualitative findings, some participants reported increased walking, moving more, or paying more attention to physical activity. While MVPA is an important goal, greater intention for physical activity or increases in less vigorous activity can also have health benefits [53]. Many SCAD survivors were highly physically active prior to SCAD but become fearful of exercise sensations, concerned about triggering a recurrent SCAD, and confused about exercise safety after SCAD since there are no evidence-based clinical guidelines [54, 55]. Walking or moving more might be an important first step to re-expose survivors to exercise and build self-efficacy, while a targeted exposure-based approach may be needed to achieve MVPA goals. Future adaptations to UpBeat-MBCT could include psychoeducation and application of mindfulness skills to thoughts and sensations of exercise, specific weekly physical activity goals, acceptance of physical activity limits, and appreciating improvements. Pairing MBCT with cardiac rehab may also be useful. The effect size for improvement in muscle strengthening exercises was large, suggesting that SCAD survivors may feel more comfortable increasing muscle strengthening rather than aerobic exercise, which may be due to the fewer chest sensations evoked by muscle strengthening.

In regard to sleep outcomes, the effect size for sleep efficiency (measured by total sleep time divided by total time in bed) was small, which may be because UpBeat-MBCT skills were emphasized for sleep outcomes in Session 1 but not consistently throughout the intervention. However, many participants in the exit interviews reported finding mindfulness helpful for sleep. These findings are consistent with previous research where sleep, when measured objectively, was inconsistent with perceived sleep quality [22, 56]; thus sleep improvements noted in our trial may be most related to perceived sleep. Previous literature discusses the bidirectional relationship between sleep health and CVD—sleep disturbances such as poor sleep quality and insufficient or excessive sleep duration can contribute to the development of CVD and vice versa [57, 58]. Mindfulness-based interventions have been shown to improve sleep outcomes, including self-reported total sleep time, sleep efficiency, and decreased sleep onset latency [59, 60]. Larger effects on sleep may require more direct application of UpBeat-MBCT skills to sleep behaviors, and/or treatment with cognitive behavioral therapy for insomnia (CBT-I), a form of CBT teaching patients techniques to modify sleep behaviors and expectations [61]. Future research may benefit from integrating CBT-I with MBCT (e.g. stimulus control, bedtime sleep restriction) and measuring a diversity of sleep outcomes using a mixed-methods approach.

MBCT is a scalable intervention, especially when delivered via telehealth, that can be implemented as an insurance-reimbursable group therapy in clinical settings [62]. MBCT is delivered by licensed mental health providers who have completed MBCT training, which typically involves participation in a multiday workshop, participant-observation of an 8-week MBCT group, and leading MBCT groups with mentorship [32]. MBCT providers are expected to maintain their own personal mindfulness practice, which can benefit providers’ own mental health and patient-provider relationships [63]. As an example of scalability, in the United Kingdom, MBCT is recommended and implemented by the UK National Health Service, with evidence of cost-effectiveness and greater clinical improvements as compared to usual care [64].

Despite the burden of cardiovascular disease in women, the prevalence and deleterious effects of FOR, and the American Heart Association’s call for psychosocial interventions for SCAD [2], SCAD remains under-researched and undertreated. A few qualitative studies have established that SCAD survivors experience significant emotional distress and need targeted psychosocial support, education, and connection with other survivors [26, 54, 55, 65]. However, to our knowledge, there have only been two other pilot studies aimed at developing targeted SCAD interventions [66, 67]. These studies used cognitive behavioral therapy [67] and acceptance and commitment therapy [66] and showed high acceptability and promising effects on anxiety and depression symptoms, but neither emphasized mindfulness meditation practice nor targeted or measured FOR. The current study was the first test of a behavioral intervention for FOR in SCAD survivors. Recognizing the detriments of unmanaged FOR, guidelines have been developed in other illness populations (i.e. cancer), but no research has focused on FOR treatment guidelines or interventions in SCAD [68]. The results of the current study greatly advance this research and highlight that SCAD survivors are eager to participate in behavioral interventions and may benefit from targeted interventions such as UpBeat-MBCT.

This study had several limitations. First, the generalizability of our results is impacted by our relative demographic homogeneity. While our lack of gender diversity may not be a limitation given that SCAD primarily affects women [69] future projects should explore MBCT for men after SCAD. Our study was also almost entirely non-Hispanic, White, and college educated. While almost 90% of reported SCAD cases are among White individuals, this may be due to referral bias and patients of minoritized groups being underdiagnosed [43, 70]. Patients of color are more likely to have to forego healthcare due to cost, increasing the risk for delayed or missed diagnosis of SCAD [71] and contributing to a misrepresentation of SCAD incidence among patients of color. Second, our open pilot design, though appropriate for the phase of research, limits the conclusions we can draw regarding UpBeat-MBCT efficacy and mechanisms. The use of completer analyses may have inflated the effect size estimates. Third, our study recruited from the Massachusetts General Hospital SCAD Program and does not reflect a nationally representative sample. We also found a low follow-up rate and did not meet feasibility benchmarks in Cohort 1, which impacts our ability to draw conclusions about intervention feasibility. However, feasibility benchmarks were met in Cohort 2 following changes made based on lessons learned in Cohort 1, emphasizing the need for pilot studies and iterative approaches in behavioral intervention development. Daily diaries did not consistently meet feasibility and acceptability benchmarks. Future research should explore ways to make daily diaries more feasible (e.g. using shorter surveys and/or more user-friendly technologies).

Overall, this open pilot study showed promising feasibility, acceptability, and potential benefits for UpBeat-MBCT to improve FOR among SCAD survivors. Adaptations between cohorts to create boundaries around emotionally difficult topics related to SCAD seemed important for intervention feasibility. Further research using randomized controlled trials and nationally representative, demographically diverse samples are needed.

Supplementary Material

Supplementary Data

Supplementary material is available at Translational Behavioral Medicine online.

Implications.

Practice:

Fear of recurrence (FOR) interventions such as Mindfulness-Based Cognitive Therapy should be considered for SCAD survivors.

Policy:

Applying FOR interventions such as Mindfulness-Based Cognitive Therapy can advance psychosocial care for women with SCAD.

Research:

Randomized controlled efficacy trials of Mindfulness-Based Cognitive Therapy to reduce FOR in SCAD survivors are warranted.

Data availability

De-identified data from this study are not available in a public archive. De-identified data from this study will be made available (as allowable according to institutional IRB standards) by emailing the corresponding author.