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

NCT ID: NCT03094000

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-01
• Study Completion Date: 2018-01-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental group (CBTE-MIND)

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 Type: EXPERIMENTAL

MIND

Intervention Type: BEHAVIORAL

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").

CBT-E

Intervention Type: BEHAVIORAL

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.

Control group (CBTE)

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

Group Type: ACTIVE_COMPARATOR

CBT-E

Intervention Type: BEHAVIORAL

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.

Interventions

MIND

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

CBT-E

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.

Intervention Type: BEHAVIORAL

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

• Current suicidal ideation
• Current substance/alcohol dependence or abuse
• Current psychosis
• Pregnancy (which began prior inclusion)
• Inability to attend treatment on a regular basis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Haifa

OTHER

Sponsor Role: collaborator

The Touro College and University System

OTHER

Sponsor Role: collaborator

Shalvata Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evelyn Steiner, MD

Role: STUDY_DIRECTOR

Shalvata Mental Health Center

References

Fairburn, C. G. (2008). Cognitive behavior therapy and eating disorders. New York: Guilford Press

Reference Type: BACKGROUND

Other Identifiers

SHA-0019-13

Identifier Type: -

Identifier Source: org_study_id