Clinical trial NCT03094000: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Bulimia Nervosa
Binge-Eating Disorder
Night-eating Syndrome
Keywords: Bulimia Nervosa
Binge-Eating
Self monitoring
Cognitive Behavioral Therapy (CBT)
Mindfulness
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
Collaborators: name: University of Haifa
name: The Touro College and University System
First posted: 2017-03-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes in the Eating Disorder Examination Questionnaire (EDE-Q-I)
timeFrame: 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)
measure: Changes in the Clinical Impairment Assesment (CIA) questionnaire
timeFrame: 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)
measure: Changes in the Night Eating Questionnaire (NEQ)
timeFrame: 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)
measure: Changes in the treatment Outcome Questionnaire-45 (OQ-45)
timeFrame: 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)
measure: Treatment outcomes as seen in the compliance to the nutritional instructions (conducted through analyzing the self monitoring documents )
timeFrame: Analyzed at 3 time points along the CBT-E program: week 1, week 10, week 19 (end of CBTprogram)
Secondary outcomes:
measure: Self monitoring adherence (conducted through scoring the self monitoring content of the participants)
timeFrame: Every week along 19 weeks of CBTE program
Other outcomes:
measure: Mediating and moderating processes between mindfulness and SM adherence: Depression and anxiety (will be examined through self-report questionnaires)
timeFrame: 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)
measure: Mediating and moderating processes between mindfulness and SM adherence: Motivation (will be examined through self-report questionnaires)
timeFrame: 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)
measure: Mediating and moderating processes between mindfulness and SM adherence: Attention deficit disorder (will be examined through self-report questionnaires)
timeFrame: 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)
measure: Mediating and moderating processes between mindfulness and SM adherence: Dissociation (will be examined through self-report questionnaires)
timeFrame: 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)
measure: Mediating and moderating processes between mindfulness and SM adherence: Obsessiveness (will be examined through self-report questionnaires)
timeFrame: 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)
measure: Mediating and moderating processes between mindfulness and SM adherence: Impulsivity, perfectionism and interoceptive awareness (will be examined through self-report questionnaires)
timeFrame: 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)
measure: Mediating and moderating processes between mindfulness and SM adherence: therapeutic alliance (will be examined through self-report questionnaires)
timeFrame: 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)
measure: Level of mindfulness
timeFrame: 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)
Locations:
Study officials:
affiliation: Shalvata Mental Health Center
name: Evelyn Steiner, MD
role: STUDY_DIRECTOR
References:
citation: Fairburn, C. G. (2008). Cognitive behavior therapy and eating disorders. New York: Guilford Press