Impact of Fordyce Happiness training program on depression severity among patients receiving hemodialysis: An experimental study

Abstract

BACKGROUND:

Depression is a common problem in hemodialysis patients and needs to be treated effectively. The Fordyce Happiness Program, an educational and performance-based intervention that promotes happiness, has shown promise as a complementary therapy to alleviate psychological disorders. This study was conducted to evaluate the impact of this program on the level of depression in hemodialysis patients at the hemodialysis department of Taleghani Treatment and Education Center, Urmia.

MATERIALS AND METHODS:

This double-blind randomized experimental study was conducted between October 5, 2021, and March 9, 2022. The research population included 60 hemodialysis patients who were randomly assigned to two groups. The experimental group received the program for 30 min during each hemodialysis session, once a week, totaling six sessions. The program encompassed communication, interviewing, and active listening techniques to enable patients to independently address their problems. The control group received standard care. Data were collected using two demographic characteristics and Beck Depression questionnaires. To assess the normality of the data, histogram and normal Q-Q plot tests were used. Chi-square tests were utilized to compare demographic factors between the two study groups. The Persian-language version of the Beck Depression Inventory-Second Edition (BDI-II) scores was analyzed using either the Mann-Whitney U test or the Kruskal-Wallis test, depending on the specific comparisons being made. A P value less than 0.05 was considered statistically significant.

RESULTS:

There was a significant difference in the mean depression scores immediately after the intervention and at the fourth week of the study when comparing the experimental group to the control group. After the intervention, the experimental group had a mean depression score of 15.95 ± 3.35, while the control group had a mean depression score of 18.23 ± 2.85. At the fourth week of the study, the experimental group had a mean depression score of 17.26 ± 2.89, whereas the control group had a mean score of 20.01 ± 1.36.

CONCLUSION:

The program showed promise in significantly reducing depression scores in patients receiving hemodialysis. However, a larger sample size to strengthen the evidence base and facilitate the integration of this program into routine clinical practice is needed.

Introduction

Hemodialysis patients often face a range of other health problems, including congestive heart failure, diabetes, and frequent hospitalizations. These factors can further reduce their quality of life. Among these challenges, depression is particularly common and can have a significant impact on a patient’s ability to manage their illness compared to those with other chronic illnesses.[1]

Depression is a common mental disorder in public health worldwide, affecting how people think, act, and feel. It is influenced by many different factors such as feelings about death, concerns about readmission, sexual issues, nutrition status, job, finances, and feelings of hope/guilt in patients that can lead to many mental and physical disorders, as well as a reduced capability to work and self-care.[2]

The development and persistence of depressive symptoms in hemodialysis patients is a common problem. Hemodialysis is a long-term treatment that can have adverse effects on the patient’s physical and psychological health.[3] In Iran, a significant proportion of hemodialysis patients with depression, approximately 60.5%, may not have sufficient knowledge about their symptoms or access to appropriate treatment options, emphasizing the need to increase education and awareness about depression in this patient group.[4]

Addressing and treating depression in hemodialysis patients is essential because it has the potential to hinder recovery and impair mental health and quality of life.[5]

Although the risk of death and suicidality associated with mental health problems is increased in hemodialysis patients, regular screening for these complications is often overlooked. It is essential to recognize the potential impact of mental health problems on the overall health and wellness of this population and to establish effective screening and treatment protocols.[6,7] Early intervention and timely treatment are essential to prevent complications related to psychological disorders. In addressing these conditions, a comprehensive approach that incorporates both non-pharmacological and pharmacological treatments should be considered. Non-pharmacological interventions, such as social support and cognitive-behavioral therapy, have gained attention in recent years for their efficacy in treating depression among patients undergoing hemodialysis. These programs, like the one mentioned, have shown positive results.[8]

Healthcare professionals must not only use non-pharmacological treatments such as the program but also be trained in these methods and be able to inform patients about them. The program provides a model to promote well-being and facilitate positive changes in patient’s mental and emotional health. Through this program, patients can develop a positive outlook on the future, respond to difficult situations positively and adaptively, and ultimately adapt more effectively to their circumstances.[7]

By addressing mental health issues in this population, healthcare professionals can enhance the overall quality of life and health outcomes of patients receiving hemodialysis.[9]

Healthcare settings need to pay attention to boosting patients’ mental health, and well-being. Excessive depression in hemodialysis patients leads to psychological injury, mental health damage, and other health problems. Experts have suggested necessary measures to prevent this problem and treat disorders and health problems where appropriate.[10]

The present study was carried out to evaluate the impact of the program on the level of depression among patients undergoing hemodialysis.

Methods and Materials

Study design and setting

In this experimental study, conducted between October 5, 2021, and March 9, 2022, patients undergoing hemodialysis and referred to hospitals were recruited using a convenient sampling method. A total of 60 patients were included in two equal groups: an experimental group and a control group consisting of 30 patients. The experimental group received the Happiness Education and Performance Program of Fordyce once a week for a total of six sessions. On the other hand, the control group received standard care. It is important to note that no further interventions were provided to either group after the completion of the program at the end of the sixth week. Sample size: To determine the appropriate sample size for this study, the Sample Size and Power Analysis software (NCSS-PASS) was utilized. They referred to a previous study by Khayeri et al.,[11] which reported a difference of 1.61 points in depression scores after implementing the program in patients with multiple sclerosis.

Based on the findings, to achieve a statistical power of 90% with a two-sided significance level of 5%, a minimum of 30 patients were required for each group. They also considered an expected dropout rate of 10%. By using these parameters, they ensured that the sample size was sufficient to detect potential differences between the experimental and control groups in depression scores after program implementation.

Study participants and sampling

The principal investigator of the study assessed all potential participants for eligibility and provided them with information about the purpose and intervention of the study. Out of the 72 patients screened, eight were found to be ineligible for participation, and four declined to take part in the study. The authors of the study, who were blind to the allocation sequence, assessed all participants’ happiness, namely, before, immediately after, and two months after the intervention.

After the informed consent process, the random assignment was conducted using a random number table, as depicted in Figure 1. It is worth noting that due to the nature of the intervention, the researcher who conducted the training sessions was not blinded to the study groups.

Figure 1.

Flow diagram of the study sample

To ensure impartiality and minimize bias, an independent statistician analyzed the data collected during the study. Therefore, the study was designed as a randomized, non-blinded, controlled trial, where the participants were allocated to different groups randomly, and the analysis of the data was performed by an independent statistician.

The study included patients who were undergoing hemodialysis and were 18 years of age or older, scheduled to receive hemodialysis two or three times per week. Participants with a history of major depression, substance dependency, any neurological disorders, or use of corticosteroids within the past six months were excluded from the study. These eligibility criteria were established to ensure that the study participants did not have pre-existing conditions that could affect the study results and to minimize potential risks associated with the intervention.

Data collection tools and technique

Once the participants were randomly assigned, the experimental group received the program once a week during their hemodialysis sessions for a total of six sessions. The program was delivered face-to-face and through question-and-response communication and mutual discussion, with each session lasting for 30 min. The program consisted of both cognitive and behavioral components.

The cognitive component of the program focused on identifying certain thoughts and behaviors that contribute to happiness, while the behavioral component taught strategies that could be useful for each participant’s daily life. In total, the Fordyce program included 14 elements, of which eight were cognitive and six were behavioral.

The program covered a range of topics such as defining depression symptoms and happiness, increasing physical activity levels, reducing demands and wishes, improving creativity techniques, preparing for social integration, increasing intimacy and managing expectations. Other topics included assigning homework, discussing experiences and suggestions, receiving feedback, applying strategies for optimism, and providing an overview of all the strategies used.[8]

The socio-demographic questionnaire used in the study collected information about the participants’ socio-demographic characteristics, including their educational level, age, employment status, gender, marital status, and financial status.

By collecting information on these variables, the researchers could control for any potential differences in baseline characteristics between the control and experimental groups. For instance, differences in age or educational level could impact the participants’ response to the program. Therefore, by collecting this information, the researchers could better understand the effects of the intervention on the study population.

The Persian Beck Depression Inventory-Second Edition (BDI-II)

The BDI-II was used as an outcome measure to assess the severity of depressive symptoms among the participants. It can evaluate depressive symptoms in psychiatric patients as well as the general population.[12]

The BDI-II consists of 21 items to assess various symptoms associated with depression, including social isolation, fatigue, decision-making difficulties, inflexibility, lack of assertiveness, reduced appetite, weight loss, sadness, dissatisfaction, health concerns, reduced sexual interest, pessimism, feelings of guilt, expectation of punishment, self-blame, self-hate, suicidal ideation, insomnia, sense of loss, tendency for crying, impaired body image, and feelings of displeasure. The scores can help categorize the severity of depression into different levels: normal condition, mild-level depression (10–19), moderate-level depression (20–29), and severe-level depression (30–63).

The scale is designed to assess various symptoms associated with depression, including social isolation, fatigue, difficulty making decisions, rigidity, insecurity, loss of appetite, weight loss, sadness, dissatisfaction, health problems, decreased sexual interest, pessimism, feelings of depression, feelings of guilt, anticipation of punishment, self-blame, self-hatred, suicidal thoughts, insomnia, feelings of loss, tendency to cry, altered body image, and feelings of insecurity satisfied. To validate the use of the BDI-II in a Persian-speaking population, Ghassemzadeh et al.[13] conducted a study and evaluated its psychometric properties. They reported test-retest reliability (r = 0.74) and an internal consistency Cronbach’s alpha value of 0.87 for the Persian version of the BDI-II. These results indicate that the scale is a valid tool for assessing depressive symptoms in Persian speakers. Using the BDI-II, the researchers in this study sought to quantify and evaluate the severity of depressive symptoms in participants before and after the implementation of the program, providing valuable information about the effectiveness of interventions aimed at reducing depression severity.

Statistical analyses were performed using IBM SPSS version 20.0 software (IBM company Armonk, N Y, U.S.A). To assess the normality of the data, histogram and normal Q-Q plot tests were used. Chi-square tests were utilized to compare demographic factors between the two study groups. The Persian-language version of the BDI-II scores was analyzed using either the Mann-Whitney U test or the Kruskal-Wallis test, depending on the specific comparisons being made. A P value less than 0.05 was considered statistically significant.

Ethical considerations

This study is the research project (IR.UMSU.REC.1400.368) sponsored by The Student Research Committee of the Deputy of Research and Technology from Urmia University of Medical Sciences, Iran. The authors maintained all the protocols before performing all the procedures engaged in this study involving human participants in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Results

The mean ages of the patients in the experimental and control groups were 33.85 ± 13.53 years and 34.17 ± 11.86 years, respectively. These values suggest that the average age of participants was comparable between the two groups.

In terms of income level, in the experimental group, 13.4% of patients had a moderate income level, while 31.6% had a low income level. In the control group, 15% of patients had a moderate income level, while 26.6% had a low income level. The remaining participants belonged to other income levels.

Regarding educational level, 30% of the experimental group and 25% of those in the control group were either illiterate or had graduated from primary school. Other educational levels were present among the remaining participants.

Table 1 provides the demographic characteristics of the study participants. Both groups had similar distributions in terms of gender.

Table 1.

Demographic characteristics of participants (n=60)

Demographic characteristics		Intervention (n=30)				Control (n=30)				Test statistic				P
		n		%		n		%
Gender
Female		15		50.0		15		50.0		0.187				0.68
Male		15		50.0		15		50.0
Age (M±SD)		33.85±13.53				34.17±11.86				1.354				0.70
Income level
High		3		5.0		5		8.4
Moderate		8		13.4		9		15.0				2.038		0.76
Low		19		34.6		16		26.6
Educational level
Illiterate or primary school		18		30.0		15		25.0
High school		9		15.0		6		10.0				1.678		0.30
University		3		5.0		9		15.0

M: Mean, SD: Standard deviation, test statistics: Student’s t-test or Chi-square test

These findings indicate that there were no significant differences in demographic characteristics between the experimental and control groups, suggesting a balanced distribution of demographics within the study sample.

Table 2 provides a significant difference in the mean depression scores between the two groups, indicating the effectiveness of the program in reducing depressive symptoms in patients undergoing hemodialysis.

Table 2.

Comparison of mean scores of depressions in the groups (n=60)

Time		M±SD				Test statistic		P
		Intervention (n=30)		Control (n=30)
Baseline (T0)		19.94±2.13		20.01±1.89		0.548		0.21
Immediately after the intervention (T1)		15.95±3.35		18.23±2.85		4.716		0.03
Four weeks after the intervention (T2)		17.26±2.89		20.01±1.36		7.253		0.03

M: Mean, SD: Standard deviation, test statistic: Independent t-test

Specifically, there was a significant difference in the mean depression scores immediately after the intervention and at the fourth week of the study when comparing the experimental group to the control group. After the intervention, the experimental group had a mean depression score of 15.95 ± 3.35, while the control group had a mean depression score of 18.23 ± 2.85. At the fourth week of the study, the experimental group had a mean depression score of 17.26 ± 2.89, whereas the control group had a mean score of 20.01 ± 1.36.

However, no significant difference was found in the mean depression scores, immediately after the intervention, and at the fourth week of the study within the control group. This suggests that the routine care provided to the control group did not have a significant impact on their depressive symptoms during the study period.

Furthermore, an independent t-test analysis indicated no significant difference in the mean depression scores between both groups at the baseline assessment (P = 0.05). This suggests that the two groups were initially comparable in terms of their depressive symptoms before the intervention was implemented.

Taken together, these findings provide evidence that the program was effective in reducing depressive symptoms among patients undergoing hemodialysis. The program resulted in significantly lower mean depression scores in the experimental group compared to the control group immediately after the intervention and at the fourth week of the study.

Participants' adherence to the Fordyce Happiness training program

Two important findings from the study are worth highlighting:

Safety and Tolerance: An important finding is that none of the participants discontinued the program due to unexpected adverse events. This suggests that the program was well-tolerated and safe for patients undergoing hemodialysis, which is particularly significant considering the comorbidities and increased risk for adverse events that these patients may have. The program’s favorable safety profile implies that it can be implemented without posing harm to patients.

Feasibility and Implementation: Another noteworthy finding is the successful implementation of the educational and performance program according to the study protocol. This indicates that the intervention is feasible and can be effectively delivered in real-world clinical settings. Feasibility is crucial as interventions that are difficult to implement or sustain may not be practical or effective in practice. The fact that all participants in the experimental group received the program sessions demonstrates its feasibility within the existing care pathway for patients undergoing hemodialysis. This finding supports the potential for wider adoption of the program to enhance the mental health and overall well-being of this patient population.

By emphasizing these points, it becomes evident that the study’s findings have positive implications regarding both patient safety and the feasibility of implementing the program in real-world clinical practice.

Discussion

The results of this study are consistent with previous research that has shown the effectiveness of the program in improving mental health outcomes, particularly depression.

Monitoring a patient’s clinical condition and their state of function, together known as quality of life measurements, is of specific importance because the psychological and physical incapacity experienced by patients has possibly serious consequences. Therefore, it is very important to recognize patients who may need increased attention and risk reduction interventions to adapt to stressful events and the next changes in life.[7]

The study by Abolghasemi et al.[9] on women found that attending happiness training sessions using the program led to increased life satisfaction and happiness in the experimental group compared to controls. The present study adds to this by demonstrating that the program was also effective in reducing depression in patients undergoing hemodialysis.

Another study by Samadzadeh et al.[14] also found that the program improved the mental health of patients undergoing hemodialysis. These findings suggest that the program may have broad applicability and could be used to improve mental health outcomes in other patient populations as well.

The results are in line with previous research that has established the effectiveness of the program in improving mental health outcomes, particularly depression, in various patient populations. No studies contradicting the findings of this study were identified.

For instance, Khayeri et al.[11] found that the program significantly reduced the severity of depression among patients with multiple sclerosis. Also, Rabiei et al.[8] reported that the program was effective in increasing happiness among family caregivers. These findings suggest that the program may be beneficial for individuals with various chronic illnesses and their caregivers.

Furthermore, Mehrabi et al.[15] found that teaching happiness resulted in a significant reduction in depression and anxiety scores among patients receiving hemodialysis, affirming the consistent positive impact of the program within this specific patient population. Nassab et al.[16] reported similar results, showing that the program was effective in reducing depression scores among elderly women. These findings highlight the potential effectiveness of the program across different age groups and populations.

The collective evidence from the study of Kheirabadi et al.[17] supports the conclusion that implementation of any cost-effective, efficient, and scientifically feasible training program on health-related behaviors can promote awareness, life satisfaction, motivation, skills, and interest, and strengthen the general health status of the clients.

The study by Narmashiri et al.[18] provides further support for the effectiveness of the program in improving various aspects of mental and physical well-being. This study specifically demonstrated positive outcomes such as reduced complications, improved physical well-being, happiness, job-related performance, and social interactions among patients in rehabilitation centers. These findings suggest that the program has the potential to have a broader impact beyond reducing depression.

Another study by Bitsko et al.[19] showed happiness as a significant predictor of quality of life, and self-care ability among adolescent patients and declared some parts of Fordyce’s program such as effective social relationships, hopefulness, and optimism can promote family caregivers abilities to provide more effective care through improving their engagement in collective activities, and social contribution.

However, it is important to consider the limitations of the present study. Firstly, the program was implemented at only one hemodialysis clinic, which limits the generalizability of the results to other patient populations or settings. To establish wider applicability, future studies should implement the program in multiple settings and diverse patient populations.

Secondly, there was no follow-up assessment after the completion of the program sessions, which restricted our understanding of the long-term effects of the intervention. Future studies could address this limitation by conducting follow-up assessments to examine the durability of the program’s effects over time.

Based on the findings, it appears that the program can be an effective intervention for reducing depression in patients undergoing hemodialysis. Given the high prevalence of depression in this population, healthcare providers, including nurses, could play a crucial role in informing patients about the potential benefits of complementary methods like the program and encouraging their participation.

Importantly, the study findings indicate that the program was well-tolerated and did not result in any side effects following the training sessions. This highlights the safety and practicality of the program as a potential intervention for improving mental health outcomes in patients with end-stage renal disease.

Overall, the results suggest that the program could be a valuable addition to the treatment and management of depression in patients undergoing hemodialysis. By incorporating complementary interventions like programs, healthcare providers have the potential to improve the mental health and well-being of this vulnerable patient population.

Study limitations

One possible limitation of the research is the inability to control confounding factors, such as the limited number of participants, their psychological state, and demographic characteristics. This limitation makes it challenging to generalize the results to other communities or complementary methods.

Conclusion

In summary, the findings suggest that interventions like the Happiness Education and Performance Program of Fordyce can effectively improve the mental health of patients undergoing hemodialysis. This highlights the significance of healthcare professionals in addressing patients’ psychological challenges and providing comprehensive care.

However, it is important to acknowledge the limitations, such as the small sample size and the inability to control for potential confounding variables. Future research with larger and more diverse populations would be valuable in addressing these limitations and obtaining a more robust understanding of the effectiveness and generalizability of the program in promoting mental health outcomes for patients undergoing hemodialysis.

Considering the high prevalence of psychological issues in this patient population, it is crucial for healthcare providers to explore new strategies, such as implementing the program, to enhance the quality of care based on health policy, and address the psychological well-being of patients receiving hemodialysis. By recognizing and addressing their mental health needs, healthcare providers can contribute to improving the overall well-being and quality of life of the patients.

Ethical considerations

The study was conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of Urmia University of Medical Sciences. All eligible participants were informed about their anonymity, voluntary participation, and confidentiality of the data. Patients with severe depression were recommended to consult with a psychologist.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

Nil.