Abstract
Background:
Depression and anxiety are common after heart transplant, and in a regional heart transplant center servicing northern California, willingness to participate in treatment can be a major barrier.
Introduction:
Our primary aim is to design a remote cognitive-behavioral therapy (CBT) intervention. This study is the first step in the process. Through a survey to the cohort of heart transplant recipients (N = 230), managed within the Kaiser Permanente Northern California's Heart Transplant Service, we aimed to assess symptoms of stress, depression, and anxiety, patient willingness to participate in a CBT intervention, and preference between video and telephone. We proposed to patients a five-visit intervention, with the first and last visits in person and the three middle visits by video.
Materials and Methods:
One hundred twenty of 230 heart transplant recipients returned the 12-question Likert-like survey. Statistical tests included chi-square, fisher exact test, t-tests, and a logistic regression model.
Results:
Patients who reported two or more symptoms of stress, depression, and anxiety were 5.67 times more likely to engage in a remote CBT intervention (odds ratio = 5.67; 95% confidence interval 1.63–19.78; p = 0.006). Patients experiencing stress with depression were the most willing group to participate in a CBT intervention. The 12 patients who met the study criteria of 3 years post-transplant and experiencing at least one mental health symptom were invited to participate in the CBT intervention. All patients (12) who met the CBT intervention criteria were not willing to participate in the two in-person visits. All were willing to participate in a telephone-only CBT intervention.
Discussion:
Among the heart transplant recipients in this cohort, there is more willingness to participate in a CBT intervention when distress is higher and there is a preference for telephone visits as the modality for treatment delivery.
Conclusions:
Based on the findings, the CBT intervention will be shorter in duration; instead of five visits, there will be four visits; and it will be conducted by telephone only. The new intervention will be tested with 8 to 10 patients, changed, and then it will need to be empirically tested.
Introduction
Telemental health (TMH) or psychiatric treatment provided remotely is effective and increases access to care. 1 Hilty et al. recommend that future studies should focus on service models, specific disorders, issues relevant to culture and language, and cost. 1
Kaiser Permanente (KP) Northern California (KPNC) is an integrated healthcare delivery system, connecting providers through an electronic health record, providing care to over 4 million members. The Heart Transplant Service, located in Santa Clara, California, includes a multidisciplinary integrated team of providers, such as cardiologists, nurse practitioners, nurses, a social worker, and a psychologist, providing left ventricular assist device and heart transplant evaluations and care before and after surgery. After surgery, patients receive care from our team for the rest of their lives.
The surgeries take place at centers of excellence, such as Stanford University Medical Center and University of California, San Francisco, so patients are not followed by KP providers for a week or two during the postsurgical recovery period until discharge.
The KP Heart Transplant Service model of behavioral healthcare includes an integrated psychologist and a social worker collaborating toward the patients' goals of care. The psychologist and social worker evaluate all patients for surgery candidacy. Patients may be eligible to receive a left ventricular assist device or heart pump and/or a heart transplant.
During the evaluation process, therapeutic relationships are established, and if there are mental health symptoms present, they are addressed before the patient's candidacy presentation to the center of excellence takes place. The evaluation period can take a few days to several years, depending on progression of the heart condition.
The psychologist provides behavioral health services in person in the clinic, in hospital at the bedside, and by telephone and video. Patients of our cohort live throughout northern California, and if in need of behavioral healthcare, and are not due for clinic visits with the cardiologist, most patients request telephone and video visits. This is in spite of the fact that each local KP provides similar services as the home facility. Since KP embraces a patient-centered approach, the services are provided as per patient preference.
Our experience in the past 10 years suggests that our transplant integrated behavioral health model increases access and patient satisfaction; however, these hypotheses need to be empirically tested.
Depression and anxiety before and after heart transplant are common. In the KPNC heart transplant cohort, ∼34.5% of patients experience both depression and anxiety symptoms. 2 According to other studies, post-transplantation, up to 60% of patients experience significant depression and anxiety. 3,4
In sum, since in our cohort of heart transplant recipients there seems to be a strong preference for TMH services, compared with services received at their home facilities, we decided to develop a TMH protocol. A remote cognitive-behavioral therapy (CBT) intervention for our cohort of heart recipients struggling with mental health symptoms could increase access to these services. The transplant psychologist provides telephone follow-ups already. An evidence-based CBT intervention could provide evidence-based remote treatment.
Dew et al. 5 state “…depressive and anxiety-related disorders and associated distress are common after transplant, and medical complications that happen after transplant can also provoke renewed distress.” These authors suggest that mental health symptoms, whether they meet criteria for a formal diagnosis or not, should be assessed and treated as they affect quality of life, morbidity, and mortality.
Dew et al. 5 write that only a few behavioral health treatment studies have been published to date, stating that there is a need for “…multicomponent psychosocial strategies, focused on risk factor reduction and enhancement of personal coping resources, to reduce psychological distress after transplant.”
In a recent randomized study with mindfulness-based stress education, for 8 weeks, home practicing and telephone monitoring showed promising results, 6 and a pilot study confirmed those results. 7
CBT has been effective in treating depression in a medical population. For example, CBT has been shown to be an effective intervention to improve adherence, depression, and glycemic control in adults with type 2 diabetes and depression. 8 CBT has been successfully tailored to address anxiety with advanced cancer 9 and it has been effective in addressing depression and adherence in patients with HIV. 10
This first step—a survey (see Appendix 1 ), in our staged approach to developing a remote CBT intervention for heart transplant recipients, was guided by the following questions: Would stressed post-heart transplant patients, who might also be experiencing depression or anxiety symptoms in the first three years after the heart transplant, be willing to participate in a brief cognitive-behavioral therapy (CBT) intervention? Would patients have a preference between the telephone and the video to receive remote treatment through? The study was approved by the KPNC Institutional Review Board.
Materials and Methods
Design
A staged approach was employed in designing a CBT intervention for heart transplant recipients. The Likert-like survey was the first step in designing the CBT intervention. The survey's main goal was to collect data to shape the intervention in a patient-centered way, improving patient willingness to engage in treatment. Another goal was to identify and obtain the consent of 8 to 10 patients who met the CBT intervention criteria—up to 3 years post-heart transplant and experiencing stress, depression, or anxiety symptoms.
The second step is to test the CBT intervention with 8 to 10 consented patients and make appropriate changes to the CBT intervention. Finally, the third and last step in designing an effective CBT intervention is to conduct a prospective, randomized controlled pilot to test the CBT intervention's efficacy.
Inclusion criteria consisted of patients who were adults, 18 years of age and older; heart transplant recipients who received a first heart transplant, retransplantation, or dual organ transplants, including the heart, such as heart–kidney; and KPNC members during the study time. Patients excluded were non-English speakers and those with severe cognitive impairment evidenced by a dementia spectrum diagnosis in the electronic medical record (EMR).
Two hundred thirty (N) post-heart transplant patients were invited to participate in the study by mail, e-mail, in-person clinic visits, when hospitalized, at the monthly support group, and through the transplant newsletter sent out to all post-heart transplant patients three times a year. A statement of consent for the survey was included in instructions on how to complete it, therefore returning the survey implied consent. Patients were asked to complete the survey within 6 weeks from the time they received the printed or electronic survey.
Data collection took place from July 2016 until August 2017. Surveys were mailed to all patients with addresses in the EMR. In addition, Survey Monkey, an online, cloud-based survey software, was used to e-mail the survey to those patients with e-mail addresses in the EMR. Patients without e-mail addresses in the EMR were invited to provide a working e-mail address. Patients e-mailed the Survey Monkey version of the survey were reminded to complete the survey automatically before the 6-week expiration date. We kept a list of patients who were mailed and e-mailed the survey to avoid duplication. To maintain patient confidentiality, each patient was assigned a study number.
Patients who met the CBT intervention criteria—up to 3 years out from their heart transplants and who self-reported stress, depression, and/or anxiety symptoms through the standardized brief instruments embedded in the survey—were mailed an invitation letter and consent to participate in a CBT intervention that included two in-person visits, which were the first and last visits, and three video visits in between. A week after the mailed invitation letter, a telephone call was placed to each patient to follow-up on intent to participate.
The CBT intervention protocol was adapted from studies by Safren et al. 11 and Greer et al. 9 and tailored for heart transplant recipients. The initial protocol development occurred in consultation with Dr. Greer and Dr. Safren as part of a Massachusetts General Hospital (MGH) early career researcher weeklong workshop on psychosocial research for cancer patients in November 2015.
CBT Intervention
Patients complete the Hospital Anxiety and Depression Scale (HADS), 12 Patient Health Questionnaire (PHQ)-9, 13 and Immunosuppressant Therapy Adherence Scale (ITAS) 14 before and after the CBT intervention. The CBT intervention consists of five visits, with one visit every other week. CBT tools can be found in the workbook Coping With Chronic Illness. 11 Before the first visit, the patient is mailed a copy of the HADS, PHQ-9, and ITAS. The patient is asked to complete them and to e-mail or mail them back to the therapist before the first visit.
Visit 1 in person
Provide a study summary and obtain consent from the patient. The patient completes the HADS, PHQ-9, and ITAS instruments. The therapist provides psychoeducation (pages 17–20 of Chapter 2). The patient is mailed a copy of Chapter 2 in the mail before this visit. The therapist discusses the CBT model (pages 20–22), current stress, depression, and anxiety symptoms and facilitates discussion of reasons for seeking treatment and, collaboratively with the patient, sets goals for the CBT intervention. Homework includes writing about stress symptoms. The patient is mailed pages 105 to 108. The patient reads the text before visit 2.
Visit 2 by video
The therapist checks on homework and then defines breathing retraining and progressive muscle relaxation (pages 105–107). The therapist leads the patient through these two techniques. Homework includes the patient tracking daily practice as discussed (page 108). The patient is mailed Chapter 5, Adaptive Thinking (Cognitive Restructuring). The patient reads the chapter before visit 3.
Visit 3 by video
The therapist checks on homework and then leads an exploration on coping after heart transplant. The therapist introduces the concept of automatic negative thoughts (stressful, depressive, and anxious), and then the patient talks about one situation and, together with the therapist, states one negative thought to work through with the thought restructuring worksheet (page 76). The therapist discusses the difference between distorted thoughts and realistic fears and points out helpful questions on page 87. Homework: the patient completes one thought restructuring worksheet. The patient is mailed Chapter 4, Activity Scheduling.
Visit 4 by video
The therapist checks on homework and summarizes evidence regarding activity planning and pacing to improve depression. The therapist introduces the activity log (page 61) and helps the patient plan the activity log for the following week. The therapist discusses management of level of energy, prioritizing activities, daily responsibilities, and pleasurable events. Homework: the patient completes the activity log for the next visit. The patient is mailed the HADS, PHQ-9, and ITAS and requested to complete them and e-mail or mail them back to the therapist before the last visit.
Visit 5 in person
The therapist checks on homework and wraps things up, reviews goals and progress toward achieving them, discusses next steps and relapse prevention, and reviews scores of HADS, PHQ-9, and ITAS before and after treatment, summarizing the findings.
The decision to include both in-person—first and last visits—and remote visits in this first version of the CBT intervention followed the assumption that an initial in-person visit would allow for a stronger therapeutic relationship to be established and the final in-person visit would provide a setting to resolve any unfinished issues. In addition, since patients do, in general, come to the clinic every 2 to 3 months, the other assumption was that one or two in-person visits would work for most patients because they would already be on-site and the behavioral health visit would be an add-on visit to their scheduled cardiologist visits and heart tests.
Survey
A Likert-like survey included 12 questions: one demographic question, the PHQ-2 15 to screen for depression, the Generalized Anxiety Disorder-2 16 to screen for anxiety, the Perceived Stress Scale-4 17 to measure stress, and three additional questions about willingness and preferences: willingness to participate in a CBT intervention, willingness to participate remotely, and preferences between telephone and video.
Statistics
Patient characteristics were broken down by mental health symptoms: stress, depression, and anxiety (Table 1). The chi-square or Fisher exact test was used to compare categorical variables. Logistic regression modeled the association between psychological symptoms and willingness to engage in a CBT intervention after heart transplant. Odds ratios (ORs) were calculated using a 95% confidence interval (CI), adjusting for patient demographic characteristics (Table 2).
Patient Characteristics
p < 0.05 (chi-square test).
p < 0.05 (Fisher exact test).
CBT, cognitive-behavioral therapy.
Multivariable Logistic Regression of Demographic Characteristics Associated with Patients' Willingness to Participate in Post-Transplant Cognitive-Behavioral Therapy Intervention (N = 120)
CI, confidence interval; OR, odds ratio.
After controlling for demographic factors in a multivariable logistic model, we found that patients with two or more mental health conditions had higher odds of willingness to participate in a CBT intervention (OR 5.67; 95% CI 1.63–19.78). There was no statistically significant relationship between age, race, gender, and time after transplantation and willingness to participate in a CBT intervention. Statistics were performed using Stata 13.0 software, and two-tailed significance was set at p < 0.05.
Findings
One hundred twenty (N) heart transplant recipients returned the 12-question survey, and patient characteristics are summarized below (Table 1): Sixty-five (54%) of 120 patients were interested in a CBT intervention if it was offered. Seventy-two (60%) of 120 patients would participate in remote treatment as part of a CBT intervention. Sixty-seven (70%) of 96 patients preferred telephone visits over video visits as remote treatment. Twenty-four patients did not answer this question. Fifty-five (46%) of 120 patients reported at least one mental health symptom, including stress, depression, or anxiety. Twenty-four (20%) of 120 patients reported at least two mental health symptoms and were willing to participate in a CBT intervention. The presence of two or three mental health symptoms was associated with more willingness to participate in a CBT intervention.
A logistic regression model (Tables 2 and 3) shows significant results in the number of mental health symptoms and patients' willingness to participate in a CBT intervention, holding other covariates constant. Patients who self-reported two or more mental symptoms were 5.67 times more likely to engage in a CBT intervention than those with no symptoms (p = 0.006).
Regression Output Analysis
LR, likelihood ratio.
Note: _cons estimates baseline odds.
Seventy-two patients—of 120 returned surveys—post-transplant indicated willingness to participate in a CBT intervention. This provides an overall sense of willingness to engage in behavioral health treatment in the whole cohort, from patients recently transplanted to those living many years after a transplant. We wanted to get a sense of willingness, in general, due to mental health stigma and general patient willingness to participate in a behavioral health treatment.
Twelve patients met the CBT intervention criteria—up to 3 years post-heart transplant; experiencing stress, depression, or anxiety symptoms; and willing to participate in the intervention. Post-transplant adjustment is challenging for patients and that is the reason we wanted to target stress, depression, and anxiety symptoms up to 3 years after transplant. Once a patient has lived for a few years after the transplant, a new normal is achieved. New complications, such as rejection and infection, as well as longevity beyond 10 years—life expectancy—can also cause new stress.
Our goal was to obtain consent from 8 to 10 patients to test the CBT intervention—the second step in our staged approach to designing the intervention. The first six patients were mailed a packet with a cover letter and attached consent, inviting them to participate in the intervention. Follow-up telephone calls were made a week later to discuss patient intent to participate.
To our surprise, none of the first six patients who met the study criteria were willing to have in-person visits. The next six patients who met the intervention criteria were also mailed a packet, and later called, and they were not willing to have in-person visits.
When asked the reason for lack of commitment to a CBT intervention, in spite of potential interest, answers included long distance from the transplant center and added lifestyle burden. A couple of patients explained that the medical management post-transplant was complex and took most of their energy, and if they needed behavioral health treatment, it would need to be delivered remotely. They were not willing to visit a provider in the psychiatry department.
As an attempt to problem-solve with patients, they were offered in-person visits paired up with their cardiologists' appointments. Even then, they were not willing to commit to seeing the psychologist twice in person as part of a 5-visit CBT intervention.
The transplant psychologist already conducts telephone visits on a regular basis with patients in need of behavioral health treatment and who do not want to meet with a psychotherapist in person in their local area. Unless patients have severe mental health problems, such as bipolar disorder, major depressive disorder with psychotic features, or present with suicidal ideation, generally, our experience has been that patients prefer to talk to the transplant psychologist or social worker by telephone instead of meeting a new psychotherapist near where they live when experiencing depression or anxiety after surgery.
Discussion
Our cohort of heart transplant recipients lives throughout northern California, a large geographic area. Two hundred thirty (N) patients were mailed or e-mailed the survey. Of the 120 returned surveys, 33 (27.5%) self-reported depression symptoms, 10 (8.33%) self-reported anxiety symptoms, and 46 (38.33%) self-reported stress. Fifty-five patients experienced any mental health symptoms (45.83%).
Mental health symptoms are common after a transplant. For example, a study suggests that transplant recipients experience depression (17%), post-traumatic stress disorder (13%), and adjustment disorder (10%). 4 In a meta-analysis, 4 depression was found to affect up to 60% of solid-organ recipients after the transplant.
In our cohort, patients with two or three mental health symptoms were the most willing patients to participate in remote treatment; however, patients who met the study criteria of up to 3 years out from heart transplant and reporting at least one mental health symptom (12) were not willing to undergo in-person CBT treatment. Distance from the transplant team and added disease burden were reasons for unwillingness to participate in in-person visits discussed by patients.
We speculate that mental health stigma may also be a barrier to treatment; however, this hypothesis needs to be tested. An advantage of remote treatment is that it is one step removed and may be a better option for these patients. This hypothesis also needs further exploration and testing.
In our cohort, the telephone was a more popular option for remote treatment delivery (70%) than video (30%). Older patients were concerned about new technology. Some of our older patients do not even have e-mail addresses and do not seem to like to use computers. The area of technology adoption and use needs further study.
Based on our survey findings, a regional transplant team should offer a CBT intervention remotely. For over 10 years, the U.S. Department of Veterans Affairs (VA) has been providing TMH services to patients in rural areas with promising outcomes. 18
TMH services may include telephone, video, and other electronic devices, and this treatment modality has been established as effective for treatment of depression, 19 obsessive-compulsive disorder, 20 and post-traumatic stress disorder. 21 A study examined the therapeutic alliance in relation to telephone-administered CBT, with positive outcomes evidenced by decreased depressive symptomatology. 22
Hilty et al. 1 state that future studies should focus on service models among other recommendations. Our study builds on existing service models by showcasing an embedded psychologist (and social worker) within a regional heart transplant team, providing TMH services through the telephone and video in addition to confidential e-mails.
Our study also builds on the work of Safren et al. 11 and Greer et al. 9 by adapting the CBT intervention and tools used with other medical populations to post-heart transplant patients. The findings from our study provide evidence that in our cohort, CBT intervention visits may be best delivered by telephone. Our study also builds on the Dew et al. 5 recommendations for behavioral healthcare of transplant patients to offer multicomponent psychosocial strategies focused on risk factor reduction and enhancement of personal coping resources.
We will plan to shorten the CBT intervention protocol to diminish the commitment time—instead of five visits, we will propose four visits. We hypothesize that our model of care—an embedded transplant psychologist, in addition to the transplant social worker—may improve patient access to behavioral health evidence-based care, as discussed by Hilty et al. 1 and others in the current scientific literature.
Study limitations include a small post-transplant sample and a small number of returned surveys. A larger sample would have provided additional power for statistical analysis. This study brings to light issues that behavioral health providers may face in regional medical services, which parallel those faced by rural patient populations, who generally live far away from their medical facility. Follow-up, randomized controlled studies to measure TMH CBT interventions with post-transplant patients are needed to provide insight into intervention efficacy.
Conclusion
Based on our survey findings, we plan to change our CBT intervention, to make it shorter, and by telephone only. The new CBT intervention will include the same pre and post self-assessment instruments, which will be e-mailed and mailed to patients before the CBT intervention. This new version of our CBT intervention, adapted for heart transplant recipients, will need to be empirically tested.
Footnotes
Disclosure Statement
No competing financial interests exist.
Appendix 1
This survey was designed to screen the level of stress that patients experience post-heart transplant. It is your choice to participate or not in this survey and your decision will not impact your care with Kaiser Permanente in any way. Completing this survey, mailing, or e-mailing it back to the investigator implies consent to participate in this study. A follow-up cognitive-behavioral intervention or a referral to a local Kaiser psychotherapist will be offered to patients who are experiencing stress symptoms. Please mail this survey back to
The same survey will be e-mailed as Survey Monkey to you in a few days in case you prefer to e-mail it back to the investigator rather than fill it out on paper. Be sure to either fill out this form OR the Survey Monkey. Please do not fill out both since they are the same.
