The Effect of Psychotherapy on Anxiety, Depression, and Quality of Life of Patients with Heart Failure: A Randomized Clinical Trial

According to the World Health Organization,1 billions of people will die worldwide from chronic noncommunicable diseases, especially cardiovascular conditions. Patients with heart disease are an object of interest in the field of mental health because of the impacts on the subjects’ lives; therefore, mind and heart are closely interconnected.2 Heart failure (HF) is a complex and progressive clinical syndrome3 in which the heart is unable to pump efficiently to supply the body’s needs, seeking compensatory hemodynamic pathways. Thus, common symptoms are dyspnea, fatigue, tiredness, exercise intolerance, weight gain, loss of appetite, nocturia, and oliguria.4 The main risk factors for hypertension are hypercholesterolemia, coronary artery disease, diabetes mellitus, smoking, and obesity.5 HF is little recognized both by the population and the political power, and affects 1% to 2% of the population worldwide, with an estimated growth of 25% until 2030.6 ORIGINAL ARTICLE International Journal of Cardiovascular Sciences. 2020; [online].ahead print, PP.0-0


Participants
Patients over 18 years old and classified as any New York Heart Association (NYHA) functional class were included. Psychotherapy patients who started using psychotropic drugs during intervention with severe neurological sequelae or severe psychiatric disorders were excluded. Participants were invited, by telephone or personal contact, to participate in the study at a specialty HF clinic, where all data were collected.

Intervention
Sociodemographic data were collected, informed consent was obtained, and then the scales were administered. Control group (CG) patients followed routine clinic visits, without psychotherapy; meanwhile, intervention group (IG) patients were scheduled to start psychotherapy with the study psychologist. The psychologist introduced participants to a shortterm psychological follow-up proposal based on a psychoanalytical approach aiming to improve depressive and anxiety symptoms and, consequently, their quality of life. This semistructured, flexible treatment plan tailored to each patient's personal demands (Treatment Plan -Annex 1) could involve, whenever possible, family members. Altogether, 12 weekly sessions were held.
Each session lasted 45 minutes, with duration monitored by a watch. The environment was maintained at a pleasant temperature (average of 23ºC), bright, with little outside noise, and included a table and two chairs (or three when there was a family member). Statements were not recorded. Session notes were taken later by the researcher.
The patients' statements showed the degree of understanding of the disease, adherence to treatment, social and family support, psychiatric history, and issues highlighted by them. The follow-up sessions addressed topics such as quality of life, lifestyle, personal, professional, religious, social, and family choices , sexuality, coping with the disease, and life itself. Patients were encouraged to talk about themselves and about aspects related to the disease, in addition to being encouraged to be assertive, to perform self-care, and to improve quality of life. Psychoanalysis, as a theoretical framework, was based on free association considering unconscious contents, insights, defense mechanisms, bonds, traumas, among other concepts, all considered in the proposed treatment plan.
In the United States and Europe, it is the leading cause of hospitalization for older individuals, with a very significant socioeconomic impact, being accountable for 68% of hospitalization expenses. 6 In Brazil, cardiovascular diseases are the main cause of death, affecting 20% of people over 30 years old. 7 It is noteworthy that 50% of all hospitalized patients are readmitted within 90 days, which is one of the main risk factors for death. 8 I Brazilian Registry of Heart Failure (BREATHE) 8 described high in-hospital mortality related to low rates of evidence-based therapy. Poor adherence to treatment is one of the main factors for decompensation. Moreover, depression is prevalent in hospitalized patients, with an average ranging from 15% to 36%. 4 This association makes adherence to treatment more difficult, increases hospitalizations, and elevates morbidity and mortality. 9 The coexistence between depressive and anxiety symptoms directly impacts quality of life. 10 Thus, it is essential that health professionals detect and treat such conditions early, in addition to developing new studies to define effective interventions. 11 In this regard, psychologists identify important obstacles, such as difficulty in understanding and accepting the disease and treatment, defense mechanisms, impasses or family conflicts, psychopathological conditions, among others. This reality was observed during psychological consultations at a specialty clinic in Niterói, Rio de Janeiro, Brazil, especially concerning the patients' physical, psychological, and social fragility, with reports of personal and family issues, depressive symptoms, anxiety, and impaired quality of life.
To our knowledge, no studies have assessed the effects of short-term psychotherapy on depression, anxiety, and quality of life of patients with HF. Therefore, this is a pioneer study that aims to assess the effects of short-term psychotherapy, under the perspective of psychoanalysis, on depression, anxiety, and quality of life of outpatients with HF.

Study design
A randomized clinical trial (RCT) was conducted with two distinct parallel groups. This RCT aimed to test a psychological intervention consisting of short-term psychoanalytic listening in patients with HF seen at a specialty clinic.

Sample size
The sample size was calculated with WinPepi 11.46, based on the sample calculation of two studies that used depression as an outcome based on BDI. The first study¹⁷ was conducted by a research group named "Heart failure: from the molecule to the population," which includes the main researcher and served as a pilot for this study because of the same patient profile. Mean score was 31.5±3.53 before intervention and 50.5±13.4 after intervention. The second study¹ 8 found the following: before intervention, scores were 29.6±10.2 for CG and 30.7±10.2 for IG; after intervention, scores were 16.0±10.6 for CG and 11.2±10.7 for IG. We considered a sample of 16 patients in each group, with a difference of 17 points, 20% of losses, a significance level of 5%, and a power of 80%.

Randomization
Randomization was performed using a simple sequence, at www.randomization.com, considering 20% of losses from an initial list with the names of patients who met the inclusion criteria.

Statistical methods
Data were organized by preparing and synthesizing a database with Microsoft Excel 2010. The data collected from the study instruments were tabulated and analyzed by SPSS, version 20.0. Categorical variables were expressed by frequency and percentage distributions and compared between groups using chi-square test and Fisher's exact test.
Continuous variables were expressed by mean and standard deviation or median and interquartile range according to the behavior of variables (normality) as identified by Kolmogorov-Smirnov test. Comparison of continuous variables between groups was performed by Student's t-test for independent samples or Mann-Whitney test.
Mean initial and final scores for quality of life, anxiety, and depression were also compared with Student's t-test for independent samples when distribution was normal, or Mann-Whitney test when distribution was non-normal. A bivariate p-value < 0.05 was considered statistically significant for all analyses.
The effect size was measured, which made it possible to add information to the concept of statistical significance. The effect size was calculated using Cohen's d.
All participants were informed about the objectives, risks, and benefits of the study, and their doubts were clarified. Then they completed the informed consent form and received a copy, as provided in Resolution no. 466/2012 of the Brazilian National Health Council (Conselho Nacional de Saúde). 19 This study ensured the confidentiality and privacy of the data collected from all participants. Figure 1 represents the flowchart of selection of participants since recruitment, as recommended by the Consolidated Standards of Reporting Trials (CONSORT) 2010. 20 Table 1 shows sociodemographic and clinical characteristics of the 32 participants, which included 16 women (50%). There was no statistically significant difference when comparing the groups (p > 0.05). Table 2 shows the results of the initial interview regarding patients' self-perception, the areas they considered most affected by HF, their expectations, and their role in treatment. Table 3 shows a comparison between the initial and final scores of IG and CG. There was a statistically significant difference between the groups in terms of quality of life and depression before and after intervention (p < 0.05). Psychotherapy proved to have a positive effect on these outcomes. Cohen's d 21 was used for the outcome quality of life (0.593), which refers to the mean effect of the intervention performed. It was not possible to calculate the effect of the outcome depression; this calculation is only possible using mean and standard deviation, but depression was calculated using median.

Discussion
This study tested a short-term psychological intervention They concluded that depression was the variable that had the strongest correlation with quality of life. Furthermore, they highlighted the lack of studies assessing outpatients.
Quality of life was moderately affected, especially in the physical dimension, which is consistent with the present study. Therefore, the innovative feature of this study, which consisted of a short-term psychological intervention conducted at a clinic that specializes in HF, was evidenced, and the results demonstrated its positive effect on depression and quality of life of patients.
Although there was no statistical significance between groups in the results for anxiety, a slight improvement in the severity of these symptoms was observed in IG. In other words, patients with moderate and severe anxiety scores had them reduced to mild, minimal, or moderate. Lundgren et al., 22 also concluded in their study of 64 participants that there was no difference in intervention between groups from the internet-based cognitive behavioral therapy (CBT) for depression. However, they found an intragroup difference in this outcome, describing an improvement in symptoms.
Depressive symptoms can be confused with HF symptoms such as fatigue, changes in sleep, and appetite. Also, periods of sadness do not necessarily represent a depressive condition. For this reason, medical assessment with proper use of screening instruments is essential. 23 It is worth mentioning that this patient profile tends to have experienced several losses intrinsic to their discourse, including health, profession, role in the family, in society, and in the marriage, leisure, and self-esteem. Within this context of vulnerability, patients face frequent and evolutionary limitations that may generate sadness or even depression.
Studies have shown that depression increases the number of readmissions, 9 as self-care is greatly impaired. Clinical outcomes are impacted by this comorbidity.
A survey 24 showed that depressive symptoms and social isolation influenced the prognosis and survival (75% in up to 1 year) of patients waitlisted for heart transplant, and individuals without this condition had a survival of up to 8 years after transplant. The authors concluded on the importance of well-defined screening and intervention in patients at risk.
The Brazilian Guideline on Heart Failure 3 and other studies emphasize the importance of psychological monitoring to patients with HF, especially in relation to depression. However, there are still few studies, especially RCTs, on psychotherapy in HF. Some research using CBT is described in the scientific literature, but with limitations in terms of sample, intervention time, and risk of bias. 25 Studies on cardiology and psychoanalysis were found in the literature, but not specific studies using the psychoanalytic approach in an HF outpatient setting. Therefore, this is a pioneer study using this approach in this patient profile with these outcomes.   Physical and emotional symptoms have significant impacts on quality of life. 10 A Brazilian study that used the same outcomes and the same scales concluded that quality of life was moderately affected, with the physical dimension being the most impacted, 10 as shown in the present study.
Another study 26  Bordoni et al., 27 described anxiety as a neglected symptom, which increases hospitalization rates, and a gap in the scientific literature. It is often related to a high expectation or even to worry or fear, commonly described by patients with HF. Lack of social and/or family support and situations of socioeconomic vulnerability may aggravate these symptoms. Studies have described the relationship of this condition with the absence of social support and inability to deal with stressful situations. 26 Such studies suggested that stress is a risk factor for acute myocardial infarction and recommended interventions focusing on prevention. Generalized anxiety disorder, for instance, may increase the risk of cardiovascular events, therefore being predictive of hospital complications and deaths. 11 Mourning experiences were described by participants and reported by Knebel & Marin 28 in their study, which assessed psychosocial factors and their psychological management 27 . Losing beloved ones was related to symptoms of depression and anxiety, in addition to loss of vitality, productivity, and sexuality.
A small sample (n = 32), only one professional to work with all participants, and irregular attendance by some of them (financial difficulties, personal and/or medical appointments, discouragement, health problems, etc.) were some of the limitations of this study. Another limitation was the extreme difficulty in contacting patients, as despite seeking constant updating, the team found incorrect or unavailable phone numbers. Using registered letters was an ineffective alternative to contact patients.
Investigating patients with HF promoted reflections and considerations for future studies, especially those using a qualitative approach. The patients' statements portrayed their vulnerability, as well as individual and collective physical and psychological suffering. Thus, future investigations should describe and analyze the content of the participants' complaints; the helpless state of patients with HF; mourning; the experience of the study psychologist at the specialty clinic; and patients' perception of the psychotherapeutic process.
We hope that the experience described in this paper can be used in other HF outpatient settings. Short-term psychotherapy using psychoanalytic listening proved to be effective in improving quality of life and depression. The semistructured, flexible treatment plan made it possible to approach patients, who were able to express their anxieties, fears, and concerns, as well to devise better ways to face illness and their personal issues. An alternative method for a high number of users is group therapy, which was not tested this time but is a future research opportunity. Moreover, other researchers are encouraged to expand this study by investigating the benefits of this process to hospital readmissions and assessing gratitude and resilience in this patient profile.

Conclusion
This study tested a short-term psychological intervention using the perspective of psychoanalysis and assessed its effect on anxiety, depression, and quality of life of patients with HF seen at a specialty clinic. The results demonstrated a positive effect of the proposed intervention on quality of life and depression in this patient profile.

Author contributions
Conception and design of the research, Writing of the manuscript, Analysis and interpretation of the data:Rocha, ICAO. Acquisition of data: Figueiredo, LS, Cruz, DCS, Freitas, RVM, Oliveira, SX. Critical revision of the manuscript for intellectual content, Supervision / as the major investigador: Cavalcanti, ACD, Mesquita, ET. Analysis and interpretation of the data: Pereira, JMV.

Potential Conflict of Interest
No potential conflict of interest relevant to this article was reported.

Sources of Funding
There were no external funding sources for this study.

Study Association
This article is part of the thesis of master submitted by Isaura Cristina Azambuja de Oliveira Rocha, from Universidade Federal Fluminense.  -Identify together with patients three priority aspects for treatment.

Ethics approval and consent to participate
-Initial demands -Assess the possibility of adjustments in lifestyle as well as encourage changes in habits, offering support and outlining coping strategies (including social, family, and religious support, social, leisure, and/or physical activities, public spaces, specialty clinics, etc.).
-Discuss the progress of the process with patients and make adjustments, if necessary.
-Discuss the possibility of changing the priority aspects of treatment.
-Provide feedback to patients.
-Address changes in personal choices.
-Address the impacts and limitations of the disease and think of possibilities or alternatives for everyday life, be it work, social interaction, or family environment. 9 th -Address treatment closure and aspects related to the termination of this bond, as well as highlight the gains obtained during therapy.
10 th and 11 th -Address some possible issues.
12 th -End the process, reinforcing all topics covered, and hand over the discharge guidance sheet.
-Deliver referral to patients who need to continue treatment.
-Administer a final questionnaire.
-New administration of the Beck Anxiety/Depression Inventory (BAI and BDI) and the Minnesota Living with Heart Failure Questionnaire (MLHFQ) by a psychologist or a nursing student.