Bulimia NervosaNCT03094000
Mindfulness Training Effect on Self-monitoring Adherence and Group CBT Outcomes for Binge Eating Disorders
A study testing MIND and CBT-E in people with Bulimia Nervosa and Binge-Eating Disorder, run by Shalvata Mental Health Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Bulimia Nervosa, Binge-Eating Disorder, Night-eating Syndrome
- What is being tested?
- MIND and CBT-E
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 1 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- Current psychosis
- Pregnancy (which began prior inclusion)
- Inability to attend treatment on a regular basis
Who cannot join
None listed.
About this study
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
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.
- Being tested
- MIND, CBT-E
- Keywords
- Bulimia Nervosa, Binge-Eating, Self monitoring, Cognitive Behavioral Therapy (CBT), Mindfulness
- Medical subject headings
- Bulimia Nervosa, Binge-Eating Disorder, Night Eating Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINDBehavioural
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-EBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (CBTE-MIND) | Experimental | 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) Receives: Behavioral: MIND; Behavioral: CBT-E |
| Control group (CBTE) | Active comparator | Group psychotherapy according to the principles of the Enhanced Cognitive-Behavioral Therapy (CBT-E) for eating disorders (Fairburn, 2008), without a mindfulness skills intervention Receives: Behavioral: CBT-E |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Analyzed at 3 time points along the CBT-E program: week 1, week 10, week 19 (end of CBTprogram)
Secondary outcomes (1)
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)
Measured: Every week along 19 weeks of CBTE program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start1 Oct 2015
- Primary completion1 Jan 2018 (estimated)
- Study completion1 Jan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Haifa, The Touro College and University System
- Responsible party
- Sponsor
- Investigators
- Evelyn Steiner, MD, Study director, Shalvata Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094000
- Sponsor's protocol ID
- SHA-0019-13
- Status last verified
- Mar 2017
- First submitted
- 19 Feb 2017
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fairburn, C. G. (2008). Cognitive behavior therapy and eating disorders. New York: Guilford Press
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03094000
- Acronym / sponsor ID
- SHA-0019-13
- Keywords
- Bulimia Nervosa, Binge-Eating, Self monitoring, Cognitive Behavioral Therapy (CBT), Mindfulness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Collaborators
- University of Haifa, The Touro College and University System
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Jan 2018 (estimated)
- Study completion
- 1 Jan 2018 (estimated)
- First posted
- 29 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group (CBTE-MIND) | Experimental | Behavioral: MIND, Behavioral: CBT-EAdding a mindfulness skills intervention to group psychotherapy according to the principles of the Enhanced Cognitive-Behavioral Therapy (CBT-E) for eating disorders (Fairburn, 2008) |
| Control group (CBTE) | Active comparator | Behavioral: CBT-EGroup psychotherapy according to the principles of the Enhanced Cognitive-Behavioral Therapy (CBT-E) for eating disorders (Fairburn, 2008), without a mindfulness skills intervention |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
- Current suicidal ideation
- Current substance/alcohol dependence or abuse
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MINDBoth 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"). | Behavioural | Experimental group (CBTE-MIND) |
| CBT-EThe 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. | Behavioural | Control group (CBTE), Experimental group (CBTE-MIND) |
Primary outcome
Changes in the Eating Disorder Examination Questionnaire (EDE-Q-I)
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)
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
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)
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)
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)
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)
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)
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 )
Time frame: Analyzed at 3 time points along the CBT-E program: week 1, week 10, week 19 (end of CBTprogram)
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).
1 secondary outcome
Self monitoring adherence (conducted through scoring the self monitoring content of the participants)
Time frame: Every week along 19 weeks of CBTE program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- BackgroundFairburn, C. G. (2008). Cognitive behavior therapy and eating disorders. New York: Guilford Press
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evelyn Steiner, MD study director
Shalvata Mental Health Center
Questions about this trial
What is this clinical trial studying?
A study testing MIND and CBT-E in people with Bulimia Nervosa and Binge-Eating Disorder, run by Shalvata Mental Health Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Eating Disorder Examination Questionnaire (EDE-Q-I) (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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03094000, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.