Effectiveness of Conventional Cognitive-Behavioral Therapy and Its Computerized Version on Reduction in Pain Intensity, Depression, Anger, and Anxiety in Children with Cancer: A Randomized, Controlled Trial

Since the last decade, the epidemiology of pain in children is considered. Childhood pain is important because of the challenges in daily life and its effects on the future. For instance, children experiencing abdominal pain are at increased risks of somatic symptoms, mental disorders, and hospital admissions for unexplained medical reasons during adolescence (1). Children with cancer often experience pain due to disease progression or treatment side effects. The prevalence of pain in such children is estimated at 25% - 50%, depending on the stage of the disease and the cause of the pain (2).

The memories of painful experiences in children may affect the way they react to later painful experiences and accept medical interventions. What is remembered about past painful events plays a pivotal role in predicting and responding to future problems (3).

Painful procedures are accompanied by negative emotions. The prevalence of anger and depression is higher in individuals experiencing chronic pain compared with healthy people (4). Chronic pain is common in children (5, 6). It can be accompanied by a significant disability (7) and may continue to adulthood. Psychological treatment includes various types of interventions for different purposes (e g, relieving pain and/or distress and improving self-efficacy). Management of pain and distress, rather than increasing functional abilities, is usually the primary outcome of such interventions (8). Cognitive-behavioral therapies (CBT) are effective in many chronic pain difficulties (9).

Significant portions of children receive inadequate assessment and management of pain in hospitals (10-13). It particularly occurs in the context of procedural pain (11, 14). Experiencing pain of greater than moderate intensity in childhood is associated with short- and long-term adverse physiological and psychological effects. Uncontrolled pain in newborns can change the process of pain, and perception can affect physiological, social, and neurocognitive development outcomes. In contrast, effective pain control strategies are associated with faster and more complete recoveries, as well as cost reductions to the health system (9). Despite the dramatic growth of therapeutic research, solution-focused interventions relying on the evidence of effective tools for pain assessment and guidelines, management practice in hospitalized children still remains a concern (13, 15).

Due to the advancement of technology and the needs of health care, various therapeutic methods, such as internet-based and computerized CBT (cCBT), are developed (16). Internet-based therapy is effective in several disorders, such as anxiety and depression (17). For children and adolescents, the research on cCBT is still limited (18), but their results are promising (19-24). In some studies, the acceptance of treatment from the perspective of patients is investigated (25, 26); cCBT is accepted as a therapeutic approach, which can overcome barriers, such as time constraints (27, 28).

Interventions applied to pain management are generally expensive (29). CBT is one of the most popular and effective pain management therapies utilized in many psychiatric disorders, such as depression and anxiety (30). It is proved that CBT is an acceptable intervention for the ones experiencing pain. CBT was designed to reduce pain, distress, and disability more than 40 years ago; it is now comprised of a set of commonly used treatments for depression, anxiety disorders, and chronic pain (6). The basic principles of CBT for controlling the pain include patient-based assistance to indicate how behavior and cognition can affect the perception of pain. During treatment, patients are encouraged to learn coping skills and reconstruct cognitions and apply coping skills to a wide range of daily activities (31). One of the negative aspects of treatment with CBT is often related to developing countries; high cost and inaccessibility make it an unavailable treatment. As the internet spreads across the globe, CBT can be implemented as internet-based interventions (20).

Babies are born in this technological era; they use computers, smartphones, laptops, and computer games as part of their daily routine. They easily move into this environment and feel comfortable inside it. Therefore, it seems that the use of technology is effective in solving youth psychological problems. However, in spite of its beginning state, research in the current area is increasing at a higher pace. There are several reasons why teenagers are reluctant to receive such treatments-e g, confidentiality concerns, shyness, and embarrassment of presence in mental health institutions, and belief in not being perceived or taken seriously. Restrictions on information about the appropriateness of this form of intervention and other factors such as financial worries, lack of access to services and long waiting lists are also among the barriers for people who need psychological help (32).

The use of technology can eliminate almost all of the abovementioned obstacles. Families can use computer-based programs at home for the sake of confidentiality; they receive treatment without fear of being seen in mental health clinics. Also, technology-based interaction has a non-inhibitory effect, which is due to anonymity; people tend to disclose themselves more often in this environment (33). Therefore, young people probably feel that their records are kept more confidential in a computer environment, and they are more comfortable to expose their personal information in such environments. A vast majority of young people (at least in the developed countries) have access to computers and the internet; and the younger generation, especially teenagers, also use the internet to receive text advice and consultations. They can eliminate the obstacles arising out of face-to-face therapy (34). In addition, most technology-based applications are consistently used. They are more accessible, and the user should not wait for treatment. They can also be used on a large scale. Therefore, technology is likely to be accepted in the youth population as a way to get help for emotional challenges they deal with them. Hence, technology can eliminate the obstacles of face-to-face therapy (35).

The experience of pain in cancer is widely recognized as a major threat to the quality of life; relief of pain is a priority in oncology care. By the disease progression, pain management should be presented at different levels from the disease onset, even for those who are in the final stages of life (36).

Cancer is one of the most painful chronic disorders in children. Because of the significant impact of childhood cancer on both the patients and their families, a computer program is designed to help children to cope more effectively with the circumstances. Because of some limitations in the availability of psychological services for such patients, cCBT may be a suitable alternative to conventional CBT due to more accessibility. Therefore, the current study aimed at examining the effectiveness of conventional CBT and its computerized version on the reduction in pain intensity, depression, anger, and anxiety in children with cancer.

The present randomized, controlled, clinical trial was performed on all patients with cancer, referring to Ahvaz Shafa Hospital, from October 2018 to the end of December 2018. The inclusion criteria were: patients with one type of cancer, age range from 9 to 12 years, literate, and fluent in Persian; the exclusion criteria were: patients with a developmental, psychiatric disorder, autism spectrum disorders (based on the diagnosis of a psychiatrist), and a history of seizure. At first, patients willing to participate in the study were randomly (using the lottery method) assigned to three groups of conventional pain (CBT), pain (cCBT), and control. Both interventions (CBT and cCBT) were performed as individual psychotherapy. The sample size was determined in the present study based on similar studies on the control of the negative psychological effects of cancer (14).

The study objectives were described to the parents, and written consent was provided by the parents. For ensuring the presence of the participants, the subjects signed an agreement, including the number of sessions and the estimated duration. All three groups received routine medical treatment until the end of the study, but two intervention groups also received psychological interventions as a complementary therapy. The control group just received the routine medical treatment, and after the research, they received the cCBT.

The CBT group attended six 45-minute psychological sessions (session 1: introduction of the program and psychoeducation about cancer; session 2: relaxation training; session 3: negative thought control; session 4: behavioral activation and self-rewarding; session 5: anger control techniques; session 6: physical activation and goal setting). The cCBT group received a guidebook including parents section and homework, as well as a compact disk containing the contents of all six CBT sessions. Psychoeducation and training were provided via texts, animations, and games. After the last session in the sixth week, the participants were reevaluated. The therapeutic package was designed based on the articles (8-14) in this area and the content of the handbook of Pain Management (37). Three clinical psychology experts confirmed the content validity of the package (Supplementary information about the design and implementation of the two interventions is being published in a separate study). In order to reduce the bias, the data (i e, pre and post-tests) were collected by a master student in clinical psychology who was blind to the study objectives. Then, the results were analyzed using MANCOVA, ANOVA, and t-test of differential scores by SPSS version 20.

In the current study, MANCOVA was used to examine the significance of the difference between the mean scores of the intervention and control groups. Prior to the implementation of MANCOVA, its assumptions (i e, normality, homogeneity of variances, and homogeneity of regression slopes) were examined. Based on the results of the Shapiro–Wilk test, the normality of the data was confirmed (P > 0.05). In addition, the Levin test results were not significant for all the variables (i e, depression, anxiety, anger, and pain), indicating that the variance of scores was consistent. In addition, the interaction between dependent variables and consistency was not significant (0.692), implying that the assumption of the homogeneity of regression slopes was true.

Table 1 shows the mean and standard deviation ± SD of the variables in pre- and post-tests. In addition, MANCOVA was used to examine differences among the three groups. The results of this analysis are presented in Table 2.

The results of Table 2 show no significant difference between the two intervention groups and the control group in terms of depression, anxiety, anger, and pain (P < 0.01). In other words, the study variables were homogenous in the three groups in the pretest.

The results of Table 3 show a significant difference between the two intervention and the control groups in the post-test in terms of depression, anxiety, anger, and pain (P < 0.0001). In other words, CBT and its computerized version could reduce depression, anxiety, anger, and pain in the post-test.

In order to investigate if CBT and its computerized version differed in the severity of pain, depression, anger, and anxiety in children with cancer, a series of t-tests were used. In addition, a series of t-tests were used to examine whether cognitive-behavioral therapy and its computerized version differ in their effectiveness in reducing pain, depression, anger, and anxiety in children with cancer. Table 4.

As Table 4 shows, the two methods of intervention used in the present study did not differ significantly in terms of the changes made into the dependent variable. However, it is shown that in CBT, the difference of anger score between pre and post-tests was greater than that of cCBT, which means the CBT was more effective in the reduction of anger reduction.

An effective pain management program should target different dimensions of pain experience (44). Various manner focusing on mental abilities and reduction of symptoms include hypnosis, music therapy, thought stopping skills, and other supportive psychotherapy methods (45). CBTs are among the most well-known methods to treat chronic pain and many psychological disorders, such as anxiety and depression (29, 34). The underlying principles of CBT help the patient understand how cognition and behavior affect the experience of illness, and teach coping skills and cognitive restructuring. Therefore, along with all the efforts made to get rid of the negative effects of cancer, experts should pay more attention to the psychological aspects of cancer.

Several studies are conducted in Iran on pain management interventions in children, which were effective in controlling and reducing pain severity and its associated psychological variables, such as anxiety and depression. A study compared the effect of distraction and touch therapy on the intensity of pain among children aged 5 - 10 years. There were two intervention groups, and controls only underwent routine pain management therapies. The obtained results showed no significant differences between the intervention groups, but both the groups had significantly lower pain intensity than controls (46). In a study entitled "Investigation of the effect of distraction using bubbles on injection-induced anxiety in school-age children with thalassemia". In this study, the intervention and control groups were compared. The mean score of anxiety in the two groups did not show any significant differences before the intervention, but the mean score of the intervention group was significantly lower than that of the control group after the intervention. It indicates that the intervention was effective in reducing anxiety (47). Several studies also show that distraction during injection reduces the behavioral responses to pain, physiological indices, and intensity of pain (48). Other methods used to reduce pain include the use of an ice pack, music, and relaxation (49). The results of a study indicated that all of these interventions were effective. Only one study in Iran was conducted on the reduction of pain intensity through psychological interventions in patients with cancer. In this study, the effect of play therapy techniques was investigated on decreasing anxiety and increasing positive emotions and the level of general adaptation in 9 - 12-year-old children with leukemia. The results showed that the intervention was effective in reducing anxiety and increasing the level of positive emotions, and improved general adaptation (50).

As the review of the literature showed, cCBT was effective in treating depression and anxiety in children and adolescents (18). Moreover, computer-assisted CBT revealed that children did not show the symptoms of anxiety after the intervention (19). The decrease in children’s anxiety was also reported in three studies using internet-based and online CBTs (20, 21, 24). The findings of these studies were in line with those of the present study. In fact, two studies, with results similar to those of the current one, were randomized, controlled trials of Cool Teens CD-ROM computerized program for adolescent anxiety; 43 adolescents with anxiety were randomly gotten with the Cool Teens program, which is a cCBT for anxiety management in 12 weeks. The results advocated the positive effect of the intervention on treating anxiety in adolescents (22). A study evaluated the effectiveness of a new cCBT as SPARX (smart, positive, active, realistic, X-factor thoughts), a computerized self-assistance intervention, on the reduction of depressive symptoms in help-seeking adolescents. In fact, SPARX is an alternative to routine care for adolescents with depression (23).

By summarizing the studies, few interventions for pain management and other outcomes of cancer were retrieved. In the study on the barriers to implement non-pharmacological methods of pain management in children and the strategies provided by nurses, the main reason for the lack of implementing such interventions was the shortage of staff in hospitals (51). In fact, the inadequacy of health care services in the management of the negative effect of cancer in children is obvious. Furthermore, the current study findings stated that the used therapeutic intervention had significant efficacy in reducing the negative effects of cancer in children. Moreover, there was no significant difference between the two interventions. It means that cCBT can be used as an effective intervention where psychological interventions are not available. Demographic variables, including age and level of education, influenced treatment outcomes as moderators. Older and very educated patients benefited more from the treatment. The next generation of pain treatment methods should approach the younger and less educated subjects (52). Therefore, in the present study, the inclusion and exclusion criteria were set in a way to control this moderator variable. The current study interventions focused on different aspects of the negative effects of pain on children. Thus, different skills, such as pain evaluation, behavioral activation, problem-solving, relaxation, attention fraction, imagination techniques, and anger control, were taught via psychoeducation.

The advantage of the present study is briefed sessions but wide coverage.

(This means that while it is short and concise, it is accessible to a large number of clients). In addition, in the program delivered by CD-ROM, the other advantages are accessibility and low-cost. The findings of the current study can provide a better battle against cancer in the affected patients.