Retrospective study of Cognitive Behavioral Therapy for Obesity modified as FIRE method (CBT-F) in combination with medication for weight loss

doi:10.21203/rs.3.rs-3440829/v1

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Retrospective study of Cognitive Behavioral Therapy for Obesity modified as FIRE method (CBT-F) in combination with medication for weight loss

https://doi.org/10.21203/rs.3.rs-3440829/v1

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Obesity rates continue to rise globally, posing a significant public health concern. Current treatments often lack long-term effectiveness, necessitating the exploration of new approaches. This study examines the effectiveness of a modified treatment method called Cognitive Behavioral Therapy modified as FIRE method (CBT-F), which combines cognitive behavioral therapy with pharmacotherapy. The study involves 62 women seeking weight loss treatment, divided into a CBT-F group and a control group receiving only pharmacotherapy. Anthropometric measures and blood chemistry data were collected over an average follow-up period of 68.5 days. The results demonstrate that the CBT-F group achieved significantly greater weight loss compared to the control group. No notable differences were observed in blood chemistry data. The combination of CBT-F and pharmacotherapy offers a comprehensive and planned approach to obesity treatment by addressing psychological factors and leveraging the effects of medication. Modules specifically designed to handle medication side effects and changes in eating behavior may contribute to treatment success and sustainability. Although this study focused on women, future research should examine the effectiveness of CBT-F in diverse populations. CBT-F shows promise as an alternative or complementary treatment option for individuals who have undergone CBT for extended periods or struggle with lifestyle changes. Overall, the findings suggest that CBT-F, with its shorter treatment duration and immediate effects of pharmacotherapy, holds potential as an effective and sustainable approach to obesity treatment. Further studies are necessary to validate these findings and expand the evidence base for this novel treatment.

CBT-F

obesity

weight loss

CBT-OB

medication therapy

Obesity is considered a major risk factor for health problems. It adversely affects nearly all physiological functions of the body and comprises a significant public health threat [1–3]. The overweight and obesity rates have increased considerably during the past 35 years. Currently, more than one-third of the world's population is classified as overweight or obese [4]. In addition to diet and exercise, surgical and psychological therapies are used, and while they have some benefits, sustainability is an issue with all of these treatments. Weight-loss medication s are commonly used to treat obesity, but their long-term use is known to have side effects[5,6]. All the obesity medication s tested over the past half century have produced disappointingly little weight loss overall, and many have had to be withdrawn from the market because of unacceptably serious side effects[7]. Combinations of slimming medication s have the potential to significantly increase weight loss and may be a worthwhile avenue to pursue, but so far anti-obesity medications have had limited success[8]. Since about 2000, Zafra Cooper and his colleagues have been conducting research on Cognitive Behavioral Therapy for Obesity (CBT-OB) around the world[9]. CBT-OB has been highly successful as a highly sustainable obesity treatment, but the length of time required to complete the program has been a barrier to patients choosing it as a treatment option. In general, CBT-OB has 6 modules and 3 phases (Preparatory stage, it is provided in Phase 1 and Phase 2). Phase 1 usually lasts about 24 weeks and phase 2 usually lasts 48 weeks[10]. To solve this problem, we developed CBT-OB modified as FIRE method (CBT-F), an original treatment method that combines CBT-OB and pharmacotherapy. Phase 1 of CBT-F is a 12-week-based treatment plan (8 visits) that adds module 1.5 between modules 1 and 2 of CBT-OB to monitor medication side effects of medication. This study aims are to compare the use of CBT-F in combination with medication therapy to medication therapy alone to see what effect it has on body weight in the medium to long term.

Participants and Study Design

A total of 62 women (age range 20–59) were included in this case-control study who presented to our FIRE CLINIC for weight loss treatment for at least 2 months (8 visits) between May 23, 2020 and September 17, 2020 and received CBT-F and pharmacotherapy (n = 42) or pharmacotherapy alone (control group) (n = 20). There was one participant (2.3%) who withdrew from CBT-F and two participants (9.1%) who withdrew from the control group.

We randomly separated participants into CBT-F and pharmacotherapy alone. Average follow-up was 68.5 days. Participants were women with a BMI more than 18.5. In this study, the results are up to phase 1 (8 visits) and phase 2 is being followed up. The results of this time will be a comparison between the baseline and the 8th visit.

The study was approved by the Institutional Ethics Committee of SOUKEN (approval number: 151574_rn-34457. Approved March 1, 2023) and conducted following the principles of the Declaration of Helsinki. All participants were given the opportunity to opt out of participation before initiating this study. Information on the study was posted on the board of FIRE CLINIC to provide participants with the opportunity to opt-out at any time of which the protocol was approved by the institutional review board.

Laboratory data

Height was self-reported, and weight were determined using a body composition analyzer (RD-803L-BK, Tanita Corp., Tokyo, Japan). Venous blood samples were collected at the first visit and 8th follow-up. Blood chemistry data [aspartate aminotransferase (AST), alanine aminotransferase (ALT) triglycerides, total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), blood sugar, hemoglobin A1c (HbA1c) and lipase] was outsourced to Health Sciences Research Institute East Japan CO., LTD. Blood was collected in tubes containing ethylenediaminetetraacetic acid and in serum separation tubes for all biochemical tests. The collected samples were kept at room temperature and collected by Insurance Sciences within 1 day and tested within 3 days.

Differences between CBT-F and CBT-OB

CBT-OB module is shown in Fig. 1 and the CBT-F module is shown in Fig. 2. CBT-F has a different module structure than CBT-OB. Table 1 shows the main procedures of the six CBT-F modules. Although the key difference is the presence or absence of pharmacotherapy, CBT-F has unique modules that result from the concurrent implementation of pharmacotherapy. Module 1.5, which involves addressing obstacles to medication side effects, begins after the completion of Module 1. Module 1.5 deals with obstacles to medication side effects and aims to prevent dropout through online (phone, email, SNS, etc.) or face-to-face encouragement.

In contrast to CBT-OB, which aims at positive changes in eating behavior, Module 2 of CBT-F focuses on retrospective acceptance of changes in appetite and eating behavior resulting from pharmacotherapy. Changes in eating behavior are very important, but they are difficult for patients to grasp, and the barriers are often high due to repeated trial and error. Module 2 of CBT-F focuses on accepting changes in eating behavior caused by medication and adapting to new eating habits. Work with the therapist to become aware of and accept the changes in life that occur when medications suppress appetite and weight loss is observed.

While CBT-OB has a Module 3, " Developing an active lifestyle" there is no equivalent module in CBT-F. This is partly because CBT-F's short- and medium-term programs focus on changing eating behaviors. However, in CBT-F Module 3, " Addressing obstacles to weight loss" there is an opportunity to discuss ways to increase activity when decreased activity is a barrier. This provides guidance on how to increase activity if a patient's activity level is lower than before or if overall activity is decreasing.

Module 4 of CBT-F is equivalent to Module 5 of CBT-OB.

Module 5 of CBT-F aims to reduce the patient's psychological dependence and burden by tapering off medication; CBT-OB is specific to the treatment of bulimia nervosa and other eating disorders, while CBT-F is aimed at those who wish to improve their body shape for the purpose of diabetes prevention, which is the difference is that CBT-F is intended to prevent diabetes and improve body shape.

Medication Therapy

The medications used (Hyguanide, GLP-1 receptor agonist, SGLT2 inhibitor, Bofu-Tsusho-San, Boiogito, Domperidone and Purimperan for anti-nausea, and others) were prescribed according to the physician's judgment as best suited for the patient.

Statistical analysis

Continuous variables are expressed as mean ± standard deviation (SD). Inter-group comparisons were performed using Welch’s t-tests for continuous variables.

All data were analyzed using SPSS version 25 (IBM Corp, Armonk, NY), and p < 0.05 was considered statistically significant.

Participant characteristics

Table 2 shows participant characteristics, including anthropometric measures, blood chemistry data and the number for each item between the control and CBT-F groups. The mean age (± standard deviation: SD) for the control group was 34.3 (± 10.9) years, compared to 35.7 (± 11.0) years for the CBT-F group. There were no significant differences between the two groups.

Blood chemistry data at final follow-up and differences in blood tests at baseline and final follow-up, shown in Tables 3 and 4, were not significantly different between the two groups. No medication-induced liver injury was observed during the short average follow-up of 68.5 days. On the other hand, the CBT-F group lost an average of 5.3 kg and the control group 2.9 kg of body weight, a significant difference, with the CBT-F group losing more weight (Fig. 3).

Although CBT-OB is considered one of the most effective tools in the treatment of obesity, its effectiveness may be limited. For example, CBT-OB alone may have limited effectiveness in cases of serious mental illness or when lifestyle habits, such as lack of exercise, are ingrained and difficult to change. On the other hand, anti-obesity medications can have a direct effect on weight loss. When these therapies are used in combination, synergistic effects can be expected, resulting in better outcomes. In fact, a comparison of the combination of CBT and anti-obesity medications with CBT and placebo reported that the former was significantly more effective in weight loss[11]. These results suggest that the combination of CBT-OB and anti-obesity medications increases the effectiveness of obesity treatment.

The combination of CBT-OB and anti-obesity medication can provide a more planned treatment; CBT-OB provides the psychological support needed to treat obesity, with a focus on improving diet and exercise. Some anti-obesity medications are fast-acting and can have a short-term effect by suppressing appetite[12]. While a typical CBT-OB lasts 24 weeks or more, CBT-F is a shorter 12-week program combined with the immediate effects of anti-obesity medications. The shorter treatment time translates into lower costs for the patient. Early weight loss is expected to increase patient motivation for obesity treatment.

However, because anti-obesity medications have side effects, caution should be exercised in their long-term use[13]. Common side effects of anti-obesity medications include dry mouth, nausea, headache, insomnia, diarrhoea and constipation. A history of high blood pressure or heart disease may also cause more severe side effects. Amphetamine-based anti-obesity medications are also known to affect the central nervous system and can cause dependence. Chronic use may reduce the effectiveness of the medication. Withdrawal symptoms have also been reported when the medication is stopped. Anti-obesity medications should be used at the minimum dose required, as long-term use can cause side effects, and Module 1.5, a feature of CBT-F, is a measure of the side effects of anti-obesity medications, and the functioning of Module 1.5 is suggested as one of the reasons for the low withdrawal rate from CBT-F. The functioning of Module 1.5 is suggested as one of the reasons for the low withdrawal rate from CBT-F. Module 2 also aims to recognise changes in eating habits due to the effects of medication and to respond to new eating habits. This enables acceptance of changes in appetite and eating behaviour and a positive attitude to treatment due to the appetite-suppressing and fat-absorbing effects of anti-obesity medications.

The limitation of the present study is that it was carried out on women only. Future studies should look at different men and ethnic groups. On the other hand, there is limited evidence on weight management interventions for young women1[14] and CBT-F is one possible intervention. In this study, the results are up to phase 1 (8 visits) and phase 2 is being followed up. Therefore, future research is needed to see if there are any differences from CBT-OB in addressing obstacles to weight maintenance and medication reduction in Pphase 2 (weight maintenance).

The use of CBT-F in obese patients may result in shorter and more sustained weight loss than treatment with weight-loss medication s alone. CBT-F may be a new treatment to improve the high initial weight loss rate of CBT-OB. The results of this study suggest that CBT-F, with its short treatment duration and rapid pharmacotherapy, has the potential to be an effective and sustainable approach to the treatment of obesity. Further studies are needed to validate these findings and expand the evidence base for this novel treatment.

Data Availability Statement: Request to the corresponding author.

Conflicts of Interest: The authors declare no conflict of interest.

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Tables 1, 3 and 4 are available in the Supplementary Files section.

Table 2 is not available with this version.

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Table 1. The main procedures of the six CBT-F modules
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Table 3. Participant characteristics at final follow-up according to CBT-F and control
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Table 4. Difference in blood tests at baseline and at the last follow-up visit

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Retrospective study of Cognitive Behavioral Therapy for Obesity modified as FIRE method (CBT-F) in combination with medication for weight loss

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