Mental Health & Prevention

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1 Mental Health & Prevention 9 (2018) Contents lists available at ScienceDirect Mental Health & Prevention journal homepage: The effect of dialectical behaviour therapy on binge eating, difficulties in emotion regulation and BMI in overweight patients with binge-eating disorder: A randomized controlled trial T Maliheh Rahmani a, Abdollah Omidi a,, Zatollah Asemi b, Hossein Akbari c a Department of Clinical Psychology, Faculty of Medicine, Kashan University of Medical Sciences, Kashan, I.R. Iran b Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran c Department of Biostatistics and Public Health, Faculty of Health, Kashan University of Medical Sciences, Kashan, I.R. Iran ARTICLE INFO Keywords: Dialectical behaviour therapy Binge eating disorder Difficulties in emotion regulation Body Mass Index ABSTRACT Objective: This study was conducted to determine the effect of dialectical behaviour therapy (DBT) on binge eating disorder (BED), difficulties in emotion regulation (DER), and body mass index (BMI) of patients suffering from BED and overweight. Methods: Sixty female binge eating disorder patients of old were randomly assigned into two groups. Thirty patients received dialectical behaviour therapy and the rest (i.e. control group) stayed in the waitlist for 10 weeks in the randomized controlled trial. Patients received a total of 20 treatments (two treatments per week). Results: After 10 weeks, DBT resulted in a significant reduction in the BMI of the patients under treatment (+3.49 ± 1.94 vs ± 1.22 kg/m 2, P < 0.001). Also, meaningful differences were observed in binge eating scale (BES) (+6.73 ± 3.22 vs ± 1.90, P < 0.001) and difficulties in emotion regulation scale (DERS) ( ± vs ± 24.32, P= 0.01) of the treatment group compared to the control group. Conclusion: This study showed that the relation of the DBT intervention had positive effects on BMI, BED and DER. 1. Introduction Obesity is a critical health issue affecting many countries in recent decades (Nestle & Jacobson, 2000). Obesity and overweight are often associated with eating disorders (Bruce & Agras, 1992; Spitzer et al., 1992). Binge eating disorder (BED) is the most prevalent eating disorder and was first categorized as a distinct diagnosis in the fifth edition of the Diagnostic and Statistical Manual (DSM-5) (De Zwaan, 2001). Previously, in DSM-IV-TR (Yanovski, 2003), it was grouped within the category of 'Eating disorder not otherwise specified' (EDNOS). BED's two core features consist in consuming more food than others in similar situations and lacking the ability to control oneself while eating (De Zwaan, 2001). It has been recommended that the treatment of pathological eating habits in obese patients should precede the treatment for their obesity (De Zwaan, 2001). However, using a treatment that targets both BED and obesity simultaneously could help patients to both successfully lose weight and maintain that weight (Yanovski, 2003). Previous research has emphasized that emotions play an important role in BED. For example, people with extreme binge eating have more negative emotions (Polivy & Herman, 1993), and when overweight BED patients experience negative emotions they are more vulnerable to BED than those who are not overweight (Eldredge & Agras, 1996). An inability to regulate emotions can stress BED patients and cause them to eat excessively (Safer, Telch, & Chen, 2009). The concept of emotion regulation has been increasingly used for investigating psychopathological patterns. Studies show that people who cannot manage their emotions in response to daily events may experience periods of disorders such as depression and anxiety (Aldao & Nolen-Hoeksema, 2010). Different treatment options have been suggested and tested for treating BED. A few studies have examined the effect of pharmacotherapy on weight loss and improving BED and have concluded that medications could aid weight loss and improve BED only for a short period of time (Agras et al., 2000; Marcus et al., 1990). However, there are studies which suggest longer-lasting results when pharmacotherapy and behaviour therapy are carried out simultaneously (Agras et al., 2000; Marcus et al., 1990). Dialectical behaviour therapy (DBT) focuses primarily on the role of emotions, whereas this is not the case in many Corresponding author. address: abomidi20@yahoo.com (A. Omidi). Received 13 January 2017; Received in revised form 28 October 2017; Accepted 13 November 2017 Available online 14 November / 2017 Elsevier GmbH. All rights reserved.

2 Fig. 1. Diagram of study procedure. treatments methods, including interpersonal psychotherapy (IPT) and cognitive behaviour therapy (CBT) (Cain, 2009). While CBT is the most researched of the evidence-based approaches for improving BED, pathological eating remains or reappears in a significant number of those treated (Halmi et al., 2002). DBT may be another suitable treatment for patients with BED, especially for those with high impulsivity (Cain, 2009). Obesity and BED are significant health issues that cannot always be adequately addressed through conventional pharmacotherapy or even surgery (Aronne, 2002; Balsiger et al., 2000; Stallone & Stunkard, 1991). Psychological treatment may be a more suitable option (Wing, 2004). The objective of this research is to investigate the efficacy of DBT for the treatment of obesity Research aim We hypothesized that DBT will reduce binge eating and weight while enhancing emotion regulation ability of BED patients. 2. Methods and materials 2.1. Participants The participants of the study were female obese or overweight patients averaging years old who suffered from binge eating and were referred to the Specialized Nutrition Clinic in Kashan, Iran from April to September Inclusion criteria Patients were included if they were obese or overweight, diagnosed as binge eater (i.e. DSM-IV-TR research criteria of 2 binge days on average over 6 months and BMI 25 kg/m 2 ), were at least 18 years old, received the prescribed diet from a nutritionist (weight loss diet in which food was distributed in the balance and there was minimum of food items according to the following pyramid (15% protein, 30% fat and 50 45% carbohydrate)) and were willing to participate in the study Exclusion criteria Exclusion criteria were: non-psychological diagnosis, compensative or purging behaviours, severe physical illnesses as the main reason of obesity (e.g. diabetics who use insulin or cancer patients who use chemotherapy), pregnancy or lactation, major depression disorder, history of drug abuse, being absent for more than 3 sessions, and the history of receiving psychological intervention during the past month Ethics statements This research project was approved by the Ethics Committee of KUMS (reference number is IR.Kaums.REC ). The study protocol was precisely explained to all potential participants before obtaining informed consent. The study was registered in the Iranian website for the registration of clinical trials. All participants signed an informed consent form Study design This study is a randomized clinical trial with a treatment and control groups. At first, the researcher went to Specialized Nutrition Clinic with a written letter of introduction from the School of Medicine, Kashan University of Medical Sciences and Health Services. 60 eligible participants entered the study after inclusion and exclusion criteria were evaluated, including scoring a 17 or higher on the Binge Eating Scale (BES). The diagnosis of BED was verified by structured clinical interview using the Diagnostic and Statistical Manual of mental disorders, 4th edition (SCID-DSM-IV TR) (Mohammadkhani, Jahani Tabesh, Tamannaiefar, & Jokar, 2009). The participants were randomly placed into treatment and control groups. Evaluating the scores was done before and after the study. At the first meeting, the researcher explained the research procedure to the participants and obtained their consent. All the participants completed a demographic information questionnaire. Patients were asked not to change their lifestyle and to maintain their usual habits, exercise, diet and medication. The height and weight of the participants (while wearing light clothes and without shoes) were also measured and recorded. All the participants took the DERS test. Their medication and diet were also 14

3 recorded. They were then randomly assigned into two groups (DBT (n = 30) and control (n = 30)) based on a table of random numbers. This process was performed randomly so the researchers were blind as to how the participants were placed into groups. Blinding was also applied when the assistant collected the required data for the study. However, the researcher who did the intervention was aware of the group allocation. Fig. 1 illustrates the study procedure Body mass index Body mass index is calculated by dividing body weight in kilogram by height squared in meters: BMI = (mass(kg))/(height(m)) Binge eating scale This self-report measure is designed to measure the intensity of binge eating in obese people (Gormally et al., 1982); it comprises 14 items with four options and two items with three options. This scale consists of a cognitive subscale (e.g. feeling guilty or preoccupied with eating limited food) and a behavioural subscale (e.g. eating fast, eating fast and alone, and eating alone) of eating disorders. Responses are graded from 0 to 3, and the overall score ranges from 0 to 46. In this scale, a score of 17 or less indicates a lack of binge eating, a score between 18 and 26 indicates medium binge eating, and a score of 27 or higher indicates severe binge eating. As the reliability and validity of this test is confirmed in Iran (Dezhkam et al., 2009; Moloodi et al., 2009), it is used in the present study. This scale does not have reverse coding Difficulties in emotion regulation scale The primary scale of emotion regulation is a self-report measuring tool that comprises 36 questions (Gratz & Roemer, 2004). It is developed to clinically measure difficulties in emotion regulation (Gratz & Roemer, 2004). Responses range from 1 to 5 in Likert scale. Factor analysis has 6 factors including rejecting emotional response, difficulty in having purposeful behaviour (purposes), difficulty in controlling impulses (impulse), lack of emotional awareness (awareness), limited access to emotion regulation strategies (strategies) and lack of emotional transparency (transparency). Higher scores show more difficulties in emotion regulation. This scale has been normalized in Iran (Alavi Kh., Amin Yazdi, & Salehi Fadardi, 2011; Shams, Azizi, & Mirzaei, 2010; Soltan et al., 2014) Structured clinical interview based on the 4th diagnostic and statistical manual of mental disorders (SCID-DSM-IV) This interview is designed based on the diagnostic criteria of the 4th diagnostic and statistical manual of mental disorders of American Psychiatric Association to diagnose mental disorders structurally. By asking questions about mental disorders symptoms in this interview, the diagnosis of BED was confirmed (Mohammadkhani et al., 2009). Validity and reliability of this scale has been examined in Iran (Amini et al., 2007; Sharifi et al., 2004). 3. Intervention 3.1. Dialectical behaviour therapy for binge eating Dialectical behaviour therapy was originally used to treat borderline personality disorder (BPD), especially those behaviours that lead to suicide and self-harm (Robins & Chapman, 2004). Currently, this type of therapy has been adapted for treating binge eating disorder (Telch, 1997). In this study, patients in the treatment groups received the DBT intervention in 20 two-hour sessions which were offered twice a week. Each session included a practice and group discussion. At the end of each session, participants were given their homework and offered some refreshments. This treatment is in accordance with Telch's (Aronne, 2002) and Telch and Linehan's treatment protocol (Telch, Agras, & Linehan, 2000, 2001). In the first two introductory sessions, dialectics, direction and treatment commitment were discussed. In the next 16 sessions, emotion regulation skills were taught through three modules. Finally, the last two sessions summarized the previous sessions and focused on relapse prevention. The three modules that were taught in the intervention were mindfulness (sessions 3 5), emotion regulation (sessions 6 12) and distress tolerance (sessions 13 18). The mindfulness module deals with non-judgmental observation and how you should describe your experiences, thoughts and emotional interests. Emotion regulation skills are concerned with how emotions work; how to reduce vulnerability to negative emotions; how to experience more positive emotions; and how to improve certain emotional feelings, such as fear or anxiety. Distress tolerance skills teach patients effective techniques for tolerating life's inevitable stresses instead of turning to binge eating. These skills also facilitate the acceptance of reality rather than prolonging suffering. The control group were told to avoid psychotherapy over the 10 weeks they were on the wait-list. They were offered treatment at the end of the wait-list period. The content of the DBT sessions is presented in Table Statistical methods and sample size The data were analyzed according to the intention-to-treat (ITT) principle using Version 18 of the Statistical Package for Social Science (SPSS Inc., Chicago, Illinois, USA). To identify differences in baseline characteristics between the two groups, the independent samples t-test was used. To determine the effects of DBT on BMI, BES and DERS, oneway repeated-measures ANOVA was used to evaluate the betweengroup changes in variables during the study. A p-value less than 0.05 was considered statistically significant. In order to examine the efficacy of intervention, the minimum sample size was calculated by the Cohen formula (Cohen et al., 2013; Cohen, 1992) and d= 0.5 was the effect size used to estimate the sample size needed. The results showed that considering 0.05 risk of a Type I error and 90% power, 26 people were needed in each group. Taking the probability of participant withdrawal and available resources into account, this study was performed on two groups of 30 patients (total of 60 patients). 4. Results As demonstrated in the study flow diagram (Fig. 1), during the intervention phase of the study, 3 persons were excluded from the DBT group [withdrawn due to personal reasons (n= 3)] and 3 persons were excluded from the control group [withdrawn due to personal reasons (n= 3)]. However, as the analysis was done based on ITT principle, all 60 participants with BED were included in the final analysis. On average, the rate of compliance in our study was high, such that more than 90% of the patients completed the treatment throughout the study in both groups. Means for age, marital status, education, employment, BMI, BES and DERS, were not significantly different between the DBT and control groups at baseline (Table 2). After 10 weeks of intervention, in the treatment group, DBT resulted in a significant reduction in BMI ( ± 1.94 vs ± 1.22 kg/ m 2, P < 0.001) (Table 3) as well as significant decreases in the BES ( ± 3.22 vs ± 1.90, P < 0.001) and DERS (79.30 ± vs ± 24.32, P= 0.01). In the DERS, the greatest smallest changes between pretest and posttest were observed in Acceptance, Awareness and Mechanism (P < 0.001) and Impulse (P= 0.02) respectively. 15

4 Table 1 Curriculum of DBT sessions. Session 1st 2nd 3rd 4th 5th 6th 7th 8th 9th 10th 11th 12th 13th 14th 15th 16th 17th 18th 19th 20th Agenda Promising to avoid binge eating, eating sparingly and mindfully, reviewing the agreements between groups members and therapist, encouraging patients to use diaries Dialectical abstinence from binge eating, diaphragmatic breathing skill Presenting three states of mind (rational mind, emotional mind, wise mind), wise mind skill What skills, practicing mindful eating, observation skill, description and being How skills, non-judgmental state, mindfulness, effectively, urge surfing, alternate rebellion Emotion regulation purposes, letting go, emotional suffering, primary and secondary emotions, current emotion skills and loving emotions The model of emotion description, ways of describing emotions, observing and describing emotions, emotion expression skill Emotion operation, emotion diary, emotion operation skill Reducing vulnerability to negative emotions, going toward increasing positive emotions, adults plan for enjoyable activities, vulnerability reduction skill, establishing dominance, creating positive experiences and positive experience mindfulness Changing emotions by acting against the current emotion Myths and legends about emotions Reviewing emotion regulation Reviewing mindfulness core skills Going toward discomfort tolerance, the important points in reality acceptance including breath observation skill Half-smiling, awareness exercise and related skills to these two Going toward acceptance skills, burning your bridges, core acceptance skills (mind flow, inclination and tendency) and burning your bridges Crisis survival skills, discomfort tolerance homework, detraction skills, self-pacification, improving now Reviewing discomfort tolerance and improving skills (reviewing all the helping factors) Reviewing mindfulness, emotion regulation and discomfort tolerance, planning for future, coping ahead Discussing future plans, farewell Table 2 Baseline characteristics of study participants. Variables Condition/Subscale Group P a 5. Discussion DBT (n= 30) Control (n= 30) Age (y) 29.8 ± ± Marriage (%) Single 1 (3.3) 2 (6.7) 0.26 Married 29 (96.7) 28 (93.3) Education (%) Below diploma 8 (26.7) 8 (26.7) 0.45 Diploma &associate 13 (43.3) 9 (30) degree Bachelor & Upper 9 (30) 13 (43.3) Job (%) Homemaker 27 (90) 23 (76) 0.80 Employee 3 (10) 7 (23.3) BMI (kg/m 2 ) ± ± BES Behaviour ± ± Cognition ± ± Total ± ± DERS Acceptance 4.01 ± ± Goals 4.26 ± ± Impulse 4.17 ± ± Awareness 4.16 ± ± Mechanism 3.97 ± ± Lucidity 4.20 ± ± Total ± ± BMI, body mass index; BES, binge eating scale; DERS, difficulties in emotion regulation scale. a Obtained from independent t-test. This study examines DBT-BED, an adaptation of DBT targeting patients with binge eating disorder. DBT-BED has been tested in two randomized trials. One was against a wait-list (Telch et al., 2001) and the other against an active comparison control (Safer & Jo, 2010). Given the few randomized studies of DBT-BED, the current study of DBT-BED versus a wait-list offers an additional replication study and, importantly, was the first to be conducted by an independent research team. In addition, this was the first study of DBT for binge eating that has been conducted in Iran. Other contributions of the study are that it tests DBT-BED within a community clinic and also tests a more compressed version of the 20-session treatment, with group sessions meeting 2x/week for 10 weeks instead of 1x/week for 20 sessions. The current study showed that DBT can reduce BMI, binge eating and difficulties in emotion regulation. Ninety percent of the intervention group completed the treatment, whereas lower retention rates are often seen in CBT (Castonguay, Eldredge, & Agras, 1995; Wilfley & Cohen, 1997). BMI was reduced after treatment (10.63%), while in short-term cognitive therapy (Fischer et al., 2014) and in CBT (Munsch et al., 2012), a reduction of only 5% in BMI has been observed. Binge eating and difficulties in emotion regulation are considered major risk factors in obesity and overweight (Erem et al., 2004). Some studies have shown that DBT results in weight loss (Safer & Jo, 2010; Safer et al., 2009), but others have not demonstrated that behavioural treatments alone have a significant impact on weight loss (Wilson, 2011). More studies are warranted to understand the effect of DBT on weight loss or binge eating. One of the indices of binge eating is difficulty with emotion regulation. DBT may help to reduce and maintain weight in obese and overweight patients who eat emotionally because of DBT's emphasis on teaching emotion regulation skills. After DBT, the improvement with regard to emotion regulation has been seen. For example, Neacsiu et al. (2014) showed DBT intervention to be more effective than group-based activities in improving emotion regulation (7.14 vs. 31.3). However, these findings were reversed in the follow-up period, when improvement in emotion regulation was not seen in the group using DBT and continued in the group using group-based activities. Attrition rates from DBT and CBT vary across different studies. For example, sample attrition in one BED treatment using DBT was 4% (Aronne, 2002) whereas in Masson et al. s guided self-help DBT study (Masson et al., 2013), it was 30%. Attrition with CBT was 24% in Grilo et al. s study (Grilo et al.,) and 30% in Wilson et al. s study (Wilson et al., 2010). The limited number of participants who dropped out of treatment in the current study may be related to satisfaction due to lost weight or maintenance of previous weight. In other words, no participant gained weight during the treatment period. The low drop-out rate could also be associated with the young age of the participants (M= years old). Young people could be more prepared than older people to participate in ongoing therapies and complete the required homework. At the end of the treatment process, emotion regulation was improved in the treatment group compared to the control group. While the DERS scores at baseline were higher in this study compared to previous studies (i.e. 145 vs. 98 (Safer & Jo, 2010), 80 (Gianini, White, & Masheb, 2013) and 94 (Eichen et al., 2017)), the reduction in scores seen in this study was consistent with the previous findings in this regard (Eichen et al., 2017; Gianini et al., 2013; Safer & Jo, 2010). The current randomized clinical trial measured treatment effect on 16

5 Table 3 Means ± SD of BMI, BES & DERS at study baseline and after 10-week intervention. DBT group (n= 30) Control group (n= 30) P a Scale Subscale Baseline End-of-trial Change Baseline End-of-trial Change BMI (kg/m 2 ) ± ± ± ± ± ± BES Behaviour ± ± ± ± ± ± Cognition ± ± ± ± ± ± Total ± ± ± ± ± ± DERS Acceptance 4.01 ± ± ± ± ± ± Goals 4.26 ± ± ± ± ± ± Impulse 4.17 ± ± ± ± ± ± Awareness 4.16 ± ± ± ± ± ± Mechanism 3.97 ± ± ± ± ± ± Lucidity 4.20 ± ± ± ± ± ± Total ± ± ± ± ± ± BMI, body mass index; BES, binge eating scale; DERS, difficulties in emotion regulation scale. a Obtained from repeated measures ANOVA test (time*group interaction). spontaneous improvement and evaluated binge eating using a structured interview. Our findings were consistent with other studies that investigated the effects of DBT on eating disorders. For instance, Safer and Jo (2010) found that DBT reduced eating disorder symptoms, anger, anxiety and depression at one year follow-up. DBT achieved its results more quickly than an active comparison group therapy in treating BED. Moreover, Salbach et al. (2006) have shown that DBT can improve disorders such as anorexia nervosa and bulimia nervosa. In addition, Palmer et al. (2003) found positive effects of DBT on treating eating and comorbid personality disorders. Our findings are also consistent with the study of Grilo and Masheb (2005). The findings of our study can be generalized to female binge eaters aged 18 and over who experience from obesity and overweight. In summary, this study independently supports prior research that DBT reduces BED symptoms and impacts other related mental health variable such as emotion regulation difficulty. In addition, it also demonstrated a significant effect on BMI. Such findings need to be replicated with long-term follow-ups. Based on such findings, we feel it is reasonable to recommend that eating disorder specialists consider using DBT, especially for those patients who did not benefit from other methods such as CBT or IPT. 6. Limitations The lack of follow-up was a major limitation in this study. Although we did not advertise for participants, once the participants were obtained, they were randomly allocated. Another limitation was that the participants of the study groups were not blind, as it was not possible to blind them to treatment group versus wait-list. A lack of data on actual binge eating frequency (at baseline and post-treatment) and percentage abstinence (at post-treatment) was another limitation of this study. Also, studies with a follow-up period and larger sample groups are needed to determine if DBT is effective in the longer term. 7. Conclusions DBT improved BMI, binge eating and emotion regulation ability. This treatment approach might be suitable option for treating binge eating and obesity. Applying DBT so that sessions are delivered over a more compressed period of time appears to be a feasible option that needs to be evaluated further as a potential way to shorten treatment length and thus save time. Acknowledgments The present study was supported by a grant from the Vice-chancellor for Research, KUMS, Iran. Authors' contributions ZA contributed in conception, statistical analysis and drafting of the manuscript. MR contributed in data collection, administration and manuscript drafting. AO and HA contributed in conception and design. Conflict of interest None. References Agras, W. S., et al. (2000). Outcome predictors for the cognitive behavior treatment of bulimia nervosa: Data from a multisite study. American Journal of Psychiatry, 157(8), Alavi Kh., M. G. M., Amin Yazdi, S. A., & Salehi Fadardi, J. (2011). 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