Mindfulness Training Effect on Self-monitoring Adherence and Group CBT Outcomes for Binge Eating Disorders

Study Overview
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Brief Summary
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Bulimia Nervosa (BN), Binge Eating Disorder (BED) and Night Eating Syndrome (NES) are Binge Eating Disorders (BE-Dis) in which binge eating episodes are a main symptom. Cognitive Behavioral Therapy (CBT) is the leading evidence-based treatment for patients suffering from these disorders. CBT-E is an enhanced trans-diagnostic version of the treatment which appears to be more effective in a variety of Eating Disorders (EDs). The main goals of this treatment are reducing dietary restrictions and EDs symptoms as well as food intake regulation. Self-monitoring (SM) is an important and central tool in this type of treatment considered crucial for its success. Therefore, during treatment, patients are required to monitor their eating, the circumstances, and their thoughts and feelings proximate to the time of eating. Nevertheless, despite the importance of this tool, research has shown that there are many difficulties challenging the clients' adherence to SM, which might reduce this treatment's effectiveness and outcome. Additionally, in recent years there has been cumulative data supporting the use of mindfulness in the treatment of EDs. Mindfulness, as a western psychological approach, is defined as the unique non-judgmental focus of one's attention at the present moment. Although SM requires the ability to observe, describe and identify occurrences, no studies have yet examined the direct effect of mindfulness skills on SM adherence, and therefore the improvement of treatment outcomes. The main objective of the present study is to examine the effect of a mindfulness based intervention on SM adherence during a CBT intervention for BE-Dis, and on the treatment outcomes as seen in the ED psychopathology and compliance to the nutritional instructions and food intake composition. Other aims include examining the differences between the experimental group and the control group, regarding their level of mindfulness and SM adherence. In addition, mediating and moderating processes between mindfulness and SM adherence will be examined.

Official Title
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A Randomized Controlled Trial Examining Mindfulness Training Effect on Self-monitoring Adherence and Group Cognitive-behavioral Treatment Outcomes Among Women Suffering From Eating Disorders

Conditions
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Bulimia Nervosa, Binge-Eating Disorder, Night-eating Syndrome

Intervention / Treatment
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* Behavioral: MIND
* Behavioral: CBT-E


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women between the ages of 18-60 who meet the criteria for BN, BED or NES according to the DSM-V. The participants will be recruited via convenience sampling among patients applying for treatment in the ED unit in Hanotrim outpatient clinic (Shalvata mental health center) and through internet advertising. Participation in the research program will be allowed only after evaluation and a diagnostic procedure to examine if the criteria for CBT are met in terms of diagnosis and motivational status. This procedure will be conducted through psychological and nutritional intake. Exclusion Criteria (contraindications to starting CBT-E immediately): Current suicidal ideation Current substance/alcohol dependence or abuse Current psychosis Pregnancy (which began prior inclusion) Inability to attend treatment on a regular basis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Following an evaluation and screening process, those who fit the criteria will be allocated randomly to one of the two research groups: experiment or control.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group (CBTE-MIND)<br>Adding a mindfulness skills intervention to group psychotherapy according to the principles of the Enhanced Cognitive-Behavioral Therapy (CBT-E) for eating disorders (Fairburn, 2008) | Behavioral: MIND<br>* Both experimental and control groups receive 20 weekly sessions (1.5 hours each), based on principles of CBT-E (Fairburn, 2008), adapted for a group format . The experimental group will receive in addition to CBT-E a mindfulness based intervention comprising of 4 weekly group sessions (1.5 hours each) during the month prior to the CBT-E program. The mindfulness skills intervention will also be practiced throughout the CBT-E program at the beginning of every group session and independently as homework. Mindfulness intervention includes formal mindfulness practice (brief mindfulness meditation - 10 minutes each) and informal mindfulness practice (Other non meditation exercises, also known as mindfulness in everyday life- eg STOP).<br>Behavioral: CBT-E<br>* The comparison group (control) will receive 4 weekly supportive-educational group sessions (1.5 hours each) prior to the group CBT-E program, with no mindfulness content or training.<br>|
| Active Comparator: Control group (CBTE)<br>Group psychotherapy according to the principles of the Enhanced Cognitive-Behavioral Therapy (CBT-E) for eating disorders (Fairburn, 2008), without a mindfulness skills intervention | Behavioral: CBT-E<br>* The comparison group (control) will receive 4 weekly supportive-educational group sessions (1.5 hours each) prior to the group CBT-E program, with no mindfulness content or training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Eating Disorder Examination Questionnaire (EDE-Q-I) | EDE-Q-I (Eating Disorder Examination Questionnaire; Fairburn & Beglin, 1994): A self-report measure of eating disorders psychopathology. | 8 Time points: Recruitment (entry to study), pre-CBT-E (5 weeks from recruitment), along CBT-E (10, 5, 20 weeks from recruitment), post-CBT-E (24 weeks from recruitment), follow-up (3 and 6 months post CBT-E = 9 and 12 months post recruitment) | 
| Changes in the Clinical Impairment Assesment (CIA) questionnaire | Assessment of psychosocial impairment due to eating disorder will be conducted through CIA (Clinical Impairment Assesment) self-report questionnaire (Bohn & Fairburn, 2008). | 8 Time points: Recruitment (entry to study), pre-CBT-E (5 weeks from recruitment), along CBT-E (10, 5, 20 weeks from recruitment), post-CBT-E (24 weeks from recruitment), follow-up (3 and 6 months post CBT-E = 9 and 12 months post recruitment) | 
| Changes in the Night Eating Questionnaire (NEQ) | Assessment of Night Eating Syndrome psychopathology will be conducted through NEQ (Night Eating Questionnaire) self-report questionnaire (Allison et al., 2008). | 8 Time points: Recruitment (entry to study), pre-CBT-E (5 weeks from recruitment), along CBT-E (10, 5, 20 weeks from recruitment), post-CBT-E (24 weeks from recruitment), follow-up (3 and 6 months post CBT-E = 9 and 12 months post recruitment) | 
| Changes in the treatment Outcome Questionnaire-45 (OQ-45) | OQ-45 (Outcome Questionnaire-45) (Lambert et al., 1996) is a self-report scale used to estimate client degree of disturbance at the outset and over the course of treatment. It measures three subscales: symptom distress (depression and anxiety), interpersonal relationships and social role (difficulties in the workplace, school or home duties). | 8 Time points: Recruitment (entry to study), pre-CBT-E (5 weeks from recruitment), along CBT-E (10, 5, 20 weeks from recruitment), post-CBT-E (24 weeks from recruitment), follow-up (3 and 6 months post CBT-E = 9 and 12 months post recruitment) | 
| Treatment outcomes as seen in the compliance to the nutritional instructions (conducted through analyzing the self monitoring documents ) | Treatment outcomes regarding the compliance to the nutritional instructions, will be examined by analyzing the participants' self monitoring reports. This analysis will be conducted by comparing the actual number of meals a day and the composition of food consumed (and reported) to dietary recommendations for the treatment of binge eating disorders (Fairburn & Wilson, 1993). Nutritional composition analysis of food consumed will be conducted by using the Tzameret software (of the Israeli Ministry of Health). This procedure will be conducted before (week 1), during (week 10) and at the end of the CBT program (week 19). | Analyzed at 3 time points along the CBT-E program: week 1, week 10, week 19 (end of CBTprogram) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self monitoring adherence (conducted through scoring the self monitoring content of the participants) | Self monitoring during the CBT-E program will be conducted electronically using the Qualtrics software via the participants' smartphones (for both groups). Adherence to self monitoring will be evaluated by analyzing and scoring the self monitoring content of each participant. In this procedure we are measuring every week along 19 weeks of CBTE program: The number of days documented in the self monitoring form The degree of detail type and quantity of food reported (The percentage of total reports) The extent (frequency) of real-time monitoring (real-time monitoring will be examined by comparing the time gaps between the reported time of eating, and the actual electronic timestamp (The percentage of total reports) The extent (frequency) which the participant used the thoughts\feelings column (The percentage of total reports) | Every week along 19 weeks of CBTE program | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bulimia Nervosa, Binge-Eating, Self monitoring, Cognitive Behavioral Therapy (CBT), Mindfulness