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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MIND
CBT-E
Sponsored by
Shalvata Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bulimia Nervosa focused on measuring Bulimia Nervosa, Binge-Eating, Self monitoring, Cognitive Behavioral Therapy (CBT), Mindfulness

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental group (CBTE-MIND)

    Control group (CBTE)

    Arm Description

    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)

    Group psychotherapy according to the principles of the Enhanced Cognitive-Behavioral Therapy (CBT-E) for eating disorders (Fairburn, 2008), without a mindfulness skills intervention

    Outcomes

    Primary Outcome Measures

    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.
    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).
    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).
    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).
    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).

    Secondary Outcome Measures

    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)

    Full Information

    First Posted
    February 19, 2017
    Last Updated
    March 22, 2017
    Sponsor
    Shalvata Mental Health Center
    Collaborators
    University of Haifa, The Touro College and University System
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03094000
    Brief Title
    Mindfulness Training Effect on Self-monitoring Adherence and Group CBT Outcomes for Binge Eating Disorders
    Official Title
    A Randomized Controlled Trial Examining Mindfulness Training Effect on Self-monitoring Adherence and Group Cognitive-behavioral Treatment Outcomes Among Women Suffering From Eating Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2015 (Actual)
    Primary Completion Date
    January 1, 2018 (Anticipated)
    Study Completion Date
    January 1, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shalvata Mental Health Center
    Collaborators
    University of Haifa, The Touro College and University System

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bulimia Nervosa, Binge-Eating Disorder, Night-eating Syndrome
    Keywords
    Bulimia Nervosa, Binge-Eating, Self monitoring, Cognitive Behavioral Therapy (CBT), Mindfulness

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group (CBTE-MIND)
    Arm Type
    Experimental
    Arm Description
    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)
    Arm Title
    Control group (CBTE)
    Arm Type
    Active Comparator
    Arm Description
    Group psychotherapy according to the principles of the Enhanced Cognitive-Behavioral Therapy (CBT-E) for eating disorders (Fairburn, 2008), without a mindfulness skills intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    MIND
    Intervention Description
    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").
    Intervention Type
    Behavioral
    Intervention Name(s)
    CBT-E
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Changes in the Eating Disorder Examination Questionnaire (EDE-Q-I)
    Description
    EDE-Q-I (Eating Disorder Examination Questionnaire; Fairburn & Beglin, 1994): A self-report measure of eating disorders psychopathology.
    Time Frame
    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)
    Title
    Changes in the Clinical Impairment Assesment (CIA) questionnaire
    Description
    Assessment of psychosocial impairment due to eating disorder will be conducted through CIA (Clinical Impairment Assesment) self-report questionnaire (Bohn & Fairburn, 2008).
    Time Frame
    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)
    Title
    Changes in the Night Eating Questionnaire (NEQ)
    Description
    Assessment of Night Eating Syndrome psychopathology will be conducted through NEQ (Night Eating Questionnaire) self-report questionnaire (Allison et al., 2008).
    Time Frame
    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)
    Title
    Changes in the treatment Outcome Questionnaire-45 (OQ-45)
    Description
    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).
    Time Frame
    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)
    Title
    Treatment outcomes as seen in the compliance to the nutritional instructions (conducted through analyzing the self monitoring documents )
    Description
    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).
    Time Frame
    Analyzed at 3 time points along the CBT-E program: week 1, week 10, week 19 (end of CBTprogram)
    Secondary Outcome Measure Information:
    Title
    Self monitoring adherence (conducted through scoring the self monitoring content of the participants)
    Description
    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)
    Time Frame
    Every week along 19 weeks of CBTE program
    Other Pre-specified Outcome Measures:
    Title
    Mediating and moderating processes between mindfulness and SM adherence: Depression and anxiety (will be examined through self-report questionnaires)
    Description
    Depression and anxiety: DASS-21 (Depression Anxiety Stress Scales-21) (Lovibond & Lovibond, 1995)
    Time Frame
    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)
    Title
    Mediating and moderating processes between mindfulness and SM adherence: Motivation (will be examined through self-report questionnaires)
    Description
    Motivation: SCQ (Stages of Change Questionnaire) (McConnaughy, Prochaska, &Velicer, 1983)
    Time Frame
    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)
    Title
    Mediating and moderating processes between mindfulness and SM adherence: Attention deficit disorder (will be examined through self-report questionnaires)
    Description
    Attention deficit disorder: ASRS (ADHD Self Report Scale) ( Kessler et al, 2005)
    Time Frame
    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)
    Title
    Mediating and moderating processes between mindfulness and SM adherence: Dissociation (will be examined through self-report questionnaires)
    Description
    Dissociation: DES (Dissociative Experience Scale ) (Freyberger et al., 1998)
    Time Frame
    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)
    Title
    Mediating and moderating processes between mindfulness and SM adherence: Obsessiveness (will be examined through self-report questionnaires)
    Description
    Obsessiveness: WISPI (Wisconsin Personality Disorder Inventory-4) (Klein et al., 1993)
    Time Frame
    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)
    Title
    Mediating and moderating processes between mindfulness and SM adherence: Impulsivity, perfectionism and interoceptive awareness (will be examined through self-report questionnaires)
    Description
    Impulsivity, perfectionism and interoceptive awareness: EDI-2 (Eating Disorders Inventory-2) (Garner, 1991)
    Time Frame
    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)
    Title
    Mediating and moderating processes between mindfulness and SM adherence: therapeutic alliance (will be examined through self-report questionnaires)
    Description
    Therapeutic alliance: WAI (Working Alliance Inventory)(Tracey & Kokotovic, 1989) - a self-report questionnaire.
    Time Frame
    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)
    Title
    Level of mindfulness
    Description
    Assessment of changes in mindfulness levels throughout the treatment and the follow up period will be conducted via self-report questionnaire: FFMQ (Five Facet Mindfulness Questionnaire) (Baer, Smith, Hopkins, Krietemeyer & Toney, 2006)
    Time Frame
    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)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Evelyn Steiner, MD
    Organizational Affiliation
    Shalvata Mental Health Center
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    Citation
    Fairburn, C. G. (2008). Cognitive behavior therapy and eating disorders. New York: Guilford Press
    Results Reference
    background

    Learn more about this trial

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

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