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
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
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
NCT ID
NCT03094000
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
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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