Sound evidence supports the value of meditation-based interventions in patients with cardiovascular disease. As far back as 1971, Wallace et al. [
The most widely available mindfulness training course is the mindfulness-based stress reduction (MBSR) program [
With this study, we sought to evaluate whether a new delivery method (phone delivery) would overcome some of the above-mentioned barriers to mindfulness training in patients with implantable cardioverter defibrillators (ICDs). This is a population with severe underlying cardiac conditions and considerable prevalence of psychological distress, with figures reaching up to 38% for clinically significant anxiety and depression [
The “Coping with ICD study” (Clinicaltrials.gov NCT01035294) is a pilot randomized clinical trial designed to evaluate the feasibility of a phone-administered, mindfulness-based training program for the treatment of psychological distress in patients undergoing an ICD procedure, or reporting an ICD-related event (shocks).
The study will be conducted at the university campus of the UMass Memorial Medical Center (UMMMC), a tertiary care medical center located in Worcester, MA admitting more than 300 patients every year for ICD procedures.
Patients scheduled for an ICD-related procedure or who recently had an ICD-related event (shocks) will be screened for study eligibility within a month of the procedure/event. All potentially eligible patients will receive a letter inviting them to participate and asking them to call a dedicated phone number to communicate their possible interest. To ensure an unbiased presentation of the study, we developed a script of the first phone contact call. If the patient expresses interest, a screening visit will be scheduled.
Patients will be eligible if they meet the following criteria: age ≥21, ICD-related procedure or recent ICD shocks
The randomization sequence will be generated using STATA [
To maximize retention, patients in both study arms will receive a weekly phone call inquiring as to whether they had questions regarding their participation. When a participant misses an intervention session, he/she will be immediately contacted. After three missed contacts, nonresponders will be sent a letter encouraging them to discuss their status. Participants will not be expected to stop any of their usual support services, for example, professional counseling, support groups, or any antianxiety or antidepressant treatment.
The study protocol and the study materials were approved by the Committee for the Protection of Human Subjects at the University of Massachusetts Medical School (Docket H-13078).
The study intervention will adapt elements of the MBSR [
Several conditions suggested the need for a modification of the standard MBSR program for ICD patients. (1) Driving is usually discouraged in ICD patients during the months immediately following ICD surgery [
The conceptual background informing the intervention was guided by the “parsimonious” model recently proposed by Carmody [
Consistently with our endeavor of adapting elements of the MBSR curriculum to meet the needs of ICD patients, the intervention’s content will be simplified to include two basic components: (1) the body scan, a technique based on the cultivation of attention to bodily sensations and cognitions that would normally go unnoticed and (2) training in the awareness of the sensations of breathing. In addition, participants will be gradually taught to direct their attention to simple activities of daily life (such as eating and drinking), to sounds, visual objects, thoughts, and emotions and to recognize when their attention is no longer focused on that specific object of attention. At the final session, participants will practice “open awareness” in which they will be instructed to just notice which events (physical sensation, sound, visual object, and/or thought) their attention will be spontaneously drawn to from moment to moment. Patients will not receive additional materials usually provided to MBSR trainees in the form of poetry or other readings. In addition, lovingkindness (“metta” practice—a technique based on deliberately generating feelings of compassion, benevolence, and acceptance towards self and others) will not be a component of the study intervention. This technique was excluded because there is insufficient evidence for a benefit of such a practice on psychological well-being in patients with cardiovascular disease and because it would imply a different study hypothesis that deserves to be tested in a separate investigation.
The study intervention will consist of eight phone-delivered, individual training sessions each lasting 30 minutes (Table
Characteristics of the study intervention.
Component | Duration | Objectives/content | Strategies/materials |
---|---|---|---|
Screening visit | 10 minutes | (i) Patient receives general instructions about the intervention by the study manager | Study CD player |
Phone sessions | 30 minutes | (i) Instructor checks on patient ability to practice specific mindfulness technique(s) taught during previous session(s) | Intervention checklist Digital recorder for session recording by the instructor |
To ensure that the delivery of the intervention will be similar across instructors we developed a script of each session. Although instructors will not have to follow the script verbatim, they will be expected to follow the sequence indicated in the script. Figure
Overview of the study intervention component by session number. Each color indicates a different component of the intervention.
The instructors will be healthcare professionals and graduates of the Center for Mindfulness Professional Training Program with at least five-year experience in mindfulness training and a personal mindfulness practice. Prior to the study beginning, they will receive three hours of training, including a detailed review of the intervention script. We will hold bimonthly meetings to discuss any questions or difficulties that might be arising during the intervention sessions. Each patient will be trained by the same instructor throughout the intervention, and although not blinded to group assignment, instructors will be blinded to the study outcomes. At the end of each session, the instructors will complete an attendance form and a checklist in which duration and delivery of the intervention as specified in the intervention script as well as their perception of the patient’s level of engagement during the session will be recorded. Patient’s engagement will be evaluated immediately after each session and scored on a scale of 1 (completely unengaged) to 10 (extremely engaged). In order to monitor the provider’s adherence to the protocol and the consistency of the delivery of the intervention across providers, each session will be digitally recorded by the instructor. Electronic copies of the attendance form, the checklist, and the MP3 file of the recorded session will be emailed weekly to the study manager.
Patients in the control group will receive the usual care provided by UMMMC to all ICD patients. Due to budgetary constraints, it was not possible to use an active control condition. To offset this limitation at least partially, patients in the usual care arm will receive a weekly phone call (duration: 5–10 minutes) that, although not designed to offer a specific intervention, will be aimed at addressing patients’ possible concerns regarding their health or the ICD. If such concerns presented, the patient will be advised to contact his/her physician or nurse at the electrophysiology clinic. This phone call will also help to equalize the amount of study contact between study arms.
Data collection will be performed at the baseline interview immediately after consent is provided, and nine weeks after enrollment once the intervention is completed.
Feasibility metrics include eligibility and recruitment rates, retention rates, intervention adherence rates, treatment fidelity, and patient’s experience with the intervention. Recruitment metrics include number of screened and eligible patients, number of eligible patients who refused to participate, and reasons for refusal. Retention measures will be the number of subjects who dropped out or were lost to followup and reason(s) for dropping out. Adherence metrics include number of sessions attended and total time spent in mindfulness practice in hours over the intervention period. In addition, the time spent engaging in each separate technique will be collected. Mindfulness practice will be self-reported by means of a daily diary that patients will receive at the consenting visit, and will be instructed to mail them back using prestamped envelopes. A similar diary was successfully used in a study [
Baseline and postintervention mindfulness scores will be measured using the Five Facets of Mindfulness (FFM) questionnaire [
Anxiety will be measured using the Hospital Anxiety and Depression Scale, [
The number of delivered shocks (if any) will be abstracted from the electronic version of the follow-up visit 9 weeks after enrollment. While patients can receive care in other centers during the follow-up period, ICD-specific follow-up visits are mostly performed at UMMMC, thus limiting the chance of missing important information about ICD functioning and arrhythmic events.
Information will be collected on demographics (age, gender, ethnicity, education, marital status, and financial status), type of ICD, indication for and time from the ICD procedure or shocks, prior history of anxiety and depression, ejection fraction and cardiac functional status, hospital readmissions during the study period, ongoing medications as well as other relevant data such as physical activity, use of other complementary medicine treatments, and life events (i.e., death or illness of spouse or relative) during the study period.
Demographic data, physical activity, use of other complementary/alternative therapies, anxiety, and mindfulness scores will be obtained from self-administered standardized questionnaires. Medical history, including past history of anxiety or depression, prescription of psychotropic medications and antiarrhythmic drugs, indication for ICD implantation, functional class, and number of shocks/arrhythmic episodes and hospital readmissions will be abstracted directly from the medical record. Study questionnaires will be administered by in-person interview at baseline and by phone interview at week 9. Questionnaires delivery via phone interview (following intervention) was preferred to mailing of questionnaires because response rates tend to be higher using the telephone as compared with mailed surveys [
Daily management of study activities will be facilitated by the use of Microsoft Access 2007 tracking system software. Scores from study questionnaires will be immediately calculated, copied into abstraction forms together with other relevant study variables, and then entered into STATA software [
Descriptive statistics will be used to describe retention and adherence indices; a graphical examination of the distribution of the continuous variables will be used to assess the need for transformation and to show patterns (e.g., whether the amount of self-reported daily mindfulness practice shows preferential “patterns” of practice). Correlations between duration of individual mindfulness practice and baseline characteristics such as age, gender, education, and severity of cardiac illness will be evaluated using Spearman’s correlation. We will assess the preliminary estimates of effect sizes of the MBI intervention on pre-/postintervention differences in mindfulness and anxiety scores using multivariate linear regression models (shown here for FFM scores):
Our planned sample size (
Sample size calculations§.
Measure | Instrument | Definition | Hypothesized mean (SD) control group | Hypothesized mean (SD) intervention group | Sample size (total) |
---|---|---|---|---|---|
Anxiety | HADS | Mean differences between baseline and postintervention | 3.0 | 5.1 | 42 |
§Null hypothesis Ho = mean difference in pre- /post-HADS score in intervention group = mean difference in pre- /post-HADS score in control group;
The purpose of this study is to evaluate whether a mindfulness-based behavioral intervention delivered over the phone and adapted to the needs of ICD patients would be feasible and acceptable to these individuals. Since the proposed intervention will involve several changes from the traditional MBSR program, the question arises of whether such changes are legitimate. Since its inception in the early eighties the MBSR program has been modified several times to meet the needs of hospitalized patients [
This study presents some limitations, which for the most part reflect its pilot nature and budgetary constraints. First, we did not have the financial and personnel resources to plan for the recruitment from additional clinical centers to achieve an ethnically diverse population. For similar reasons we will not be able to have an active control comparison group. Under ideal conditions, a three-arm randomization to a nurse education intervention, a mindfulness intervention, and usual care would probably be the optimal design. A usual care comparison group does not control for the possible effect deriving from the interaction with the instructor, independently of the intervention administered. Second, study assessments will occur only before and after the intervention. Further data collection points (i.e., at six months and one year) would provide useful information about a possible long-term effect of the intervention on anxiety and possibly on the number of shocks. However, this pilot study is a very preliminary exploration of the possible effects of a mindfulness-based intervention on anxiety in cardiac patients and specifically, in ICD-implanted patients. It seems that evidence of a short-term effect is warranted before the analysis can be carried on further. Third, study participants will not be blinded. This is a common limitation of behavioral interventions; however, assessors will be blinded to patients’ treatment allocation status and the instructors will be blinded to study outcomes. Finally, the individual mindfulness practice will be self-reported. With adequate funding, it would be possible to develop techniques to track the amount of time that each participant listens to the study CD, such as the device used by Bauer-Wu et al. [
In conclusion, this project has potentially great significance considering the prevalence of anxiety in this population (up to 40%) [
The authors declare that there is no conflict of interests.
Dr E. Salmoirago-Blotcher is funded by a Grant from the National Center for Complementary and Alternative Medicine (NCCAM F32-AT005048).