Efficacy of acceptance and commitment therapy (ACT) on depression, pain acceptance, and psychological flexibility in married women with breast cancer: a pre- and post-test clinical trial

Abstract Objective: Breast cancer is the most common cancer in women worldwide. Many of these patients suffer from multiple psychological symptoms. The present study aimed to investigate the impact of acceptance and commitment therapy (ACT) on depression, pain acceptance, and psychological flexibility in married women with breast cancer. Methods: The present study was a pre- and post-test clinical trial with intervention and control groups. The research population consisted of women with breast cancer referred to the Ayatollah Yasrebi and Shahid Beheshti Hospitals in Kashan in 2018. Through a purposive sampling method, 40 women were selected and randomly divided into two groups, namely, intervention (n = 20) and control (n = 20). The applied tools included the Depression, Anxiety and Stress Scale (DASS-21), Chronic Pain Acceptance Questionnaire 8 (CPAQ-8), and Acceptance and Action Questionnaire - II (AAQ-II). Data were analyzed by SPSS 16 using descriptive statistics and analysis of variance (ANOVA). Results: The results showed that ACT treatment significantly reduced the mean scores of depression compared to the control group (F = 107.72, p < 0.001). The mean scores of pain acceptance (F = 9.58, p < 0.05) and psychological flexibility (F = 10.61, p < 0 .05) significantly increased in comparison with the control group. Conclusion: ACT can be considered as an effective therapeutic approach to reduce depression and increase pain acceptance and psychological flexibility in women with breast cancer. These changes appear to be due to improved acceptance of thoughts and feelings associated with cancer and increased psychological flexibility, which is the primary goal of ACT treatment. Clinical trial registration: Iranian Registry of Clinical Trials (IRCT), IRCT20190518043620N1.


Introduction
Breast cancer is the most commonly occurring cancer in women worldwide and has been reported as the second leading cause of cancer deaths. 1 It affects Iranian women a decade earlier when compared to their counterparts in developed countries. 2,3 According to statistics, the risk of breast cancer in women worldwide is 22.26%. 4 This disease accounts for about one-third of all cancers in women and is the leading cause of death between the ages of 35 and 45. 5 The first line of treatment is surgery, but a combination of trastuzumab, pertuzumab, and a kind of chemotherapy called taxane also are applied. 6 Despite widespread advances in the biological treatment of breast cancer, some problems based on biopsychosocial aspects of this disease remain unsolved.
Patients experiencing significant pain and suffering from worry about the future of family members, fear of death, reduced functionality, likelihood of malformations, financial and social problems, body image disorders, and sexual problems are among the factors that affect the mental health of patients with breast cancer. 5,7 In particular, three crucial factors have been leading to widespread disability: depression, pain acceptance, and psychological flexibility.
Studies suggest that depression is one of the most common problems that cancer patients are faced with. 7 Some studies have reported that the likelihood of major depression in patients with breast cancer is two times greater than in the general population. 8 A study has shown that the death risk in adults with cancer who have depression is higher than among those without depression. 9 One of the characteristics of depressed people is the lack of flexibility in different contexts. Psychological flexibility is defined as the ability to adapt to changing environmental stimuli. Some researchers describe it as the ability of the individuals to fully communicate with the present as a conscious human being and their ability to change or continue behaving in the direction of their values. [10][11][12] What makes a person psychologically vulnerable to depression and anxiety is mental involvement with memories and probable events. 13 Studies have shown that psychological flexibility-based therapies effectively improve the physical and psychological symptoms of depression disorders. 14 Also, pain is an essential factor leading to disability and reduced quality of life in these patients. Various research studies have demonstrated that medication and rehabilitation do not eliminate the severity of chronic pain. [15][16][17] Because pain has a bio-psycho-social dimension and consists of a constellation of affective, cognitive, and neural factors, a combination of evidence-based psychotherapies and medication is required for its healing. 15  Research has shown that ACT could overcome those obstacles. As a trans-diagnostic approach, ACT deals with the essential pathological core of mental problems rather than specifically with one particular symptom.
The ACT therapeutic approach consists of six central processes that lead to psychological flexibility. The six processes include: acceptance, cognitive diffusion, contact with the present moment, self-as-context, values, and committed action. ACT takes its name from its original message, i.e., acceptance of what is out of your control and commitment to taking action that enriches your life. 21,29 Previous studies have demonstrated efficacy of ACT in improving depression and stress in Iranian patients with breast cancer, 30,31 in reducing pain in American patients with breast cancer, 29 and in improving both depression and anxiety in breast cancer patients in Colombia. 32 However, those studies have some important limitations, such as lack of followup period, 30,31 non-random selection, no control for demographic variables, 31 small sample size, 32 and lack of integrated protocol. 29 Also, based on our literature search, there is not any randomized clinical trial currently available targeting these symptoms.
In an attempt to overcome those limitations, the objective of the present study was to determine whether ACT is effective in reducing depression, increasing pain acceptance, and improving psychological flexibility in a sample of Iranian women with breast cancer.

Trial design
The present study was a pre-and post-test clinical trial with intervention and control groups. The intervention group received ACT and was then been compared with patients in a waiting list (control group).

Participants and randomization
The research population consisted of women with and control (n = 20) groups. They were motivated to participate in the program and willing to cooperate with the research team. Informed consent forms were obtained before the initial interview.

Patient selection
The following inclusion criteria were observed in this study: 1) having a diagnosis of breast cancer by a physician; 2) not presenting other serious diseases (chronic obstructive pulmonary disease, pulmonary disease, diabetes etc.); 3) being at least 18 years old; 4) having at least primary school education level; 5) being married; 6) being motivated to participate in the program; 7) having a depression score ≥ 10 according to the Depression, Anxiety and Stress Scale (DASS-21); 8) having an anxiety score ≥ 8 according to DASS-21 test; and 9) having no history of hospitalization in psychiatric section.
The following exclusion criteria were also taken into consideration: 1) participation in any psychiatric intervention during the course of this study; 2) failure to attend more than two sessions; 3) failure to the homework; 4) reporting suicidal thoughts during the study; and 5) unwillingness to continue the research.

Procedure
Participants were tested at three time points, namely: before and after the intervention and 2 months after the intervention. In all three assessments,  Table 1.

Control group
The control group did not receive any intervention.
Instead, the principal investigator informed patients for total score. 35 In another study, internal consistency was also assessed using Cronbach's alpha values, with the following results for depression, anxiety, and stress: 0.77, 0.79, and 0.78, respectively. In criterion validity assessment, the correlation found between DASS-21 and the Beck Depression Inventory was 0.70, with the Zung Self-Rating Anxiety Scale it was 0.67, and with the Perceived Stress Test 0.49. All of these correlations were significant at p < 0.001 level. 36

Chronic Pain Acceptance Questionnaire (CPAQ)
The Persian version of this tool, like its original version, assesses chronic pain acceptance in two subscales focusing on committed action (11 items) and reluctance to accept pain (9 items). In this scale, scores

Second session
Assessment of prior session assignment, assessment of patients' problems from ACT perspective, extraction of avoidance experience, mixing and individual values. Homework: Providing a list of the advantages and disadvantages and approaches to problem control.

Third session
Assessment of prior session assignment, highlighting the inefficiency of controlling negative events using metaphors and training the tendency toward negative emotions and experiences. Homework: Registering situations in which the patients could eliminate ineffective control approaches.

Fourth session
Assessment of prior session assignment, training distinction between evaluations and personal experiences (bad cup metaphor) and adopting a position of observing the thoughts without judgment. Homework: Registering situations in which the patients could observe but did not evaluate experiences and emotions.

Fifth session
Assessment of prior session assignment, communicating with the present moment and considering it as the context (chessboard metaphor) and teaching mindfulness exercises. Homework: Registering situations in which the patients were able to observe thoughts using mindfulness techniques.

Sixth session
Assessment of prior session assignment, identifying patients' life values and evaluating values based on their importance. Homework: Providing a list of obstacles to the realization of values.

Seventh session
Assessment of prior session assignment, presenting practical solutions to eliminate the obstacles while applying metaphors and planning for commitment to pursue values. Homework: Preparing a report on the steps to pursue values and contemplating the outcomes of the sessions.

Eighth session
Summing up the concepts discussed during sessions, asking members to explain their achievements to the group and talking about their plans for their lives. shows good discriminant validity. The AAQ-II appears to measure the concept similarly to AAQ-I, but has better psychometric stability. 40

Results
In this study, 40 women were randomly assigned to two different groups; there were no dropouts at any of the study stages. and no significant differences were found between the two groups for these variables either.
The mean and standard deviation values found for depression, pain acceptance, and psychological flexibility at the three evaluation stages are shown in Table 3. Based on these results, the mean depression    Table 4 shows the results of repeated measures ANOVA.
As it seen in this table, there were significant differences in severity of depression symptoms (F = 107.72, p < 0.001), mean changes of pain acceptance (F = 9.58, p < 0.05) and mean changes of psychological flexibility (F = 10.61, p < 0.05) in the intervention group.

Discussion
The current study aimed to investigate the effect of ACT on depression, pain acceptance, and psychological flexibility in married women with breast cancer. women with breast cancer, the authors found that ACT effectively reduced the severity of perceived pain and increased pain acceptance. 44   seems that the process of acceptance and mindfulness, and the process of changing behavior, end up improving the morale of patients with breast cancer. 21,30,33 This study's limitations are the use of self-report tools and the lack of consideration of other mental and psychological problems in women with breast cancer. Also, because of the difficulty associated with investigating these patients, the sample size was small. One possible way around the small sample size would be to offer ACT-based psychological treatment in specialized cancer treatment units and also at outpatient treatment clinics that see both men and women in different age groups. Assessing larger groups is suggested to validate the approach here presented.
Finally, it would be interesting to compare this approach with other therapies and to evaluate their therapeutic effect over a more extended follow-up period.

Conclusion
According to the results, ACT was an effective therapeutic approach to reduce depression and increase pain acceptance and psychological flexibility in women with breast cancer. These changes appear to be achieved through increased acceptance of thoughts and feelings associated with cancer and increased psychological flexibility, which is the primary goal of ACT treatment.