Effectiveness of mindfulness-integrated cognitive behavior therapy on anxiety, depression and hope in multiple sclerosis patients: a randomized clinical trial.

INTRODUCTION
Multiple sclerosis (MS) is a chronic medical condition that attracts particular attention because of the high risks associated with it. MS patients suffer from medical problems, depression, anxiety, and reduced hopefulness. These issues can increase the severity of the disease and treatment resistance and reduce patients' individual and social efficacy. Mindfulness-integrated cognitive behavior therapy (MICBT) is a new approach that is being applied in chronic diseases and can be used in combination with existing treatments. Therefore, the present study investigated the efficacy of MICBT in terms of anxiety, depression, and hope in MS patients.


METHODS
A sample of 20 patients with MS was randomly selected at Shafa Hospital in Kerman City, Iran. Patients were then assigned to one of two groups of 10 people using a random number table. The experimental group received MICBT. The control group also received the same therapy after study completion. The assessment tools used in this study included the Beck Depression Inventory-Second Edition (BDI-II), Beck Anxiety Inventory (BAI), and Miller Hope Scale (MHS). Measurements were conducted at three stages: pre-test, post-test, and follow-up. For data analysis, means and standard deviations were calculated and one-way analysis of covariance was conducted using SPSS 24.


RESULTS
Compared with controls, MICBT was effective for reducing depression (P < 0.001, F = 72.55), anxiety (P < 0.001, F = 100.75). Additionally, MICBT was effective in improving hope (P < 0.001, F = 45.36). Changes were maintained in the follow-up phase.


CONCLUSION
The MICBT affects depression, anxiety and hope of MS patients. Therefore, mental health professionals can benefit from the results obtained in the present study to reduce depression and anxiety and increase hope in this group of patients.


CLINICAL TRIAL REGISTRATION
Iranian Registry of Clinical Trials, IRCT201601030258N4.


Introduction
Multiple sclerosis (MS) is a complicated, disabling, and immune-related disease, involving the central nervous system (CNS), including the brain and the spinal cord.
The etiology of MS remains unidentified; the consensus is that MS is probably caused by either an abnormality of the immune system, or contact with environmental factors (infectious agents), or a combination of both. 1 Experts recognize MS as an autoimmune disease; indicating that the immune system mistakenly attacks the body's healthy organs as though they were foreign invaders. MS is among the most prevalent chronic diseases of the CNS and it is a demyelinating disease, affecting motor-sensory functions. 2 It is estimated that approximately 2-3 million people suffer from MS globally; According to Iran's MS Association, there are 40,000 MS patients in Iran, 9,000 of whom are registered cases. 3 MS frequently occurs in the 20-40 years age group 4 ; i.e. the age associated with greatest family and social responsibilities and with reproduction. 5 Due to its nature, numerous mental symptoms are with reduced hope in relation to life. 7 Untreated depression in patients diagnosed with a physical illness can lead to symptoms such as magnifying and exacerbating physical symptoms, excessive referral to medical settings and use of healthcare, increased treatment costs, involvement in high-risk behaviors, and even suicide. 8 Anxiety is another mental problem in this group. Anxiety has been overlooked in MS patients, despite its disabling consequences. 6 Moreover, persistent anxiety may exacerbate the disease and lead to cardiovascular disorders. 9 Awareness of the degenerative nature of the disease causes anxiety in patients. 10 Recent studies indicate that the prevalence rate of anxiety in MS patients is 37%. 11 Additionally, MS patients recognize anxiety as the most disabling sign of their disease. 12 Hopefulness is impacted negatively in MS, like any other chronic diseases. 13

Study design
This was a repeated measure clinical trial study with a control group. The study consisted of one experimental group (that received MICBT), and one control group.

Statistical population and sampling method
The statistical population of the current study included all MS patients who were referred to Shafa Hospital in Kerman City, Iran, from February 21 to April 20, 2018, and diagnosed with MS by a neurologist.

Sample size
The sample size was calculated on the basis of prior research, using the formula shown below. 20 The sample size needed in each group was estimated as about 8 people, for a 95% confidence interval (CI) and a 20% type II error. However, considering probable losses from samples, this number was increased to 10, for a total sample size of 20 patients. A total of 41 patients were initially invited to participate in the study; but some of them were excluded because they did not meeting the inclusion criteria for the study. There were no losses from the sample at the post-test or follow-up stages of the present study.

Inclusion and exclusion criteria
The inclusion criteria for the study were a diagnosis of relapsing-remitting MS by a neurologist; confirmation of MS diagnosis by diagnostic procedures (e.g. magnetic resonance imaging, etc.); patient aware of MS disease for 1 year prior to enrollment; age in the range of 18-50 years; signature of written informed consent form for participation in the study; and education to at least the 9th grade (to be able to complete the questionnaires). Exclusion criteria comprised comorbid physical illnesses; psychosis and/or delirium during the course of treatment; severe arousals (e.g. extreme anger, uncontrolled restlessness, or impulsiveness); and receiving other psychological treatments during the course of the study.

Interventions and randomization
Each study participant was coded with a number after enrolment. The sample was divided into two groups (10 patients per group) with a computerized random number generator, using the permuted block randomization method. Control group members also received MICBT after study completion.

Study tools
The demographic data questionnaire This was a questionnaire constructed by the researchers, covering age, gender, and educational level.

individuals excluded
No interest in participation (10) History of drug abuse (2) Session times incompatible (5) Medicine type and dose incompatible (3) Other reasons (1)

Intervention procedure
The In the fifth session, the second stage was continued at a more challenging level and the third stage was introduced. The sixth session consisted of introduction of assertiveness skills and role-playing as a means of encounter. In the seventh session, the fourth stage was introduced and at the eighth session, the fourth phase was consolidated and the entire intervention program was reviewed. 15 Table 1 provides further details of the contents of the treatment sessions.

Data analysis
The data obtained were analyzed using SPSS 24.
Mean scores and standard deviations were calculated and one-way analysis of covariance (ANCOVA) was conducted.

Ethical considerations
Prior to initiating the study, a meeting was held to explain the project to patients.

Results
Descriptive findings of research: Table 2 lists the demographic variables for the sample participants.
As per Table 2    group, more than in the control group. Additionally, hope increased in the intervention group.

Data on the research hypotheses
To determine whether the data obtained fulfilled the underlying assumptions for use of ANCOVA, they were tested prior to analyzing the hypothesis data. The test results showed that ANCOVA could be conducted.
The assumptions examined included the following: for the post-test data and Table 5 shows results for the follow-up phase.
Observing the results from Table 3 and examining the mean values for experimental and control groups in post-experimental data from Table 2, it can be concluded that post-intervention, MICBT group therapy was successful for reducing depression and anxiety scores and improving hope scores. The results in Table   4 show that the difference between the two groups in The results in Table 5 show that the differences between the two groups in depression (P < 0/001, P = 85.87), anxiety (P < 0/001, F = 89. 19), and hope (P < 0/001, F = 88.35) were still significant at the follow-up stage.

Discussion
The data obtained suggest that MICBT significantly decreased depression in the experimental group, compared to controls, and that its impact was self-esteem. 33 The present study also revealed that MICBT significantly reduced anxiety in the experimental group, compared with controls, and that this effect was sustained until the follow-up stage. These findings are consistent with other studies. 18,20,29

Disclosure
No conflicts of interest declared concerning the publication of this article.