Eating DisordersNCT04433663
Eating Disorders, Self Regulation and Mentalization
A study of Eating Disorders, run by Tel Hai College at 1 site in Israel.
Trial summary
A randomized blinded feasibility study using the Eating Attitudes Test (EAT-26) and the Reflective Functioning Questionnaire RFQ - as the main outcome to assess two interventions for eating disorders. Read more about this study
- Who is it for?
- Ages 17 to 30 years, women only
- Conditions the study is for
- Eating Disorders
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteIsrael
- Study dates
- 2 Sep 2018to 1 May 2020
- 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 17 to 30 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants were previously diagnosed with eating disorder (Eat-26>21)
- 17 yrs age and older
- no acute suicidality
- no physical risks due to eating disorder's symptoms
Who cannot join
- age <17 yrs old
- refusal to corporate with treatment
- Need of 24 hrs medical care
Trial locations and contacts
1 site in 1 country.
Israel1 site
Academic College of Tel Hai
Kiryat Shmona, North of Israel, 1220800
About this study
Official title: Eating Disorders, Emotion Regulation, and Mentalization: Addressing the Gap Between Theory and Practice
A randomized blinded feasibility study using the Eating Attitudes Test (EAT-26) and the Reflective Functioning Questionnaire RFQ - as the main outcome to assess two interventions for eating disorders. Six experienced therapists, and their consecutively 8-9 admitted clients, were randomly allocated to the intervention group and control group. The sample included a total of 52 participants, all women, mean age 24.2 yrs. old. In the intervention group, participants received mentalization-based psychotherapy with ECOSA - a novel developed mentalization tool and in the control group, participants received interpersonal psychotherapy that focused on resolving interpersonal problems and symptomatic recovery. Four randomized samples for each participant were checked for therapy-focused fidelity by two different psychotherapists.
Read the detailed description
Six experienced therapists (more than 10 yrs. in the eating disorders' treatment) within one eating disorder center, were randomly allocated using the excel randomization function to the intervention group and control group. All participants in the clinical sample were drawn consecutively from admitted population to these therapists in a community-based eating disorder center between September 2018 to April 2019. The sample (total of 52 patients) included 26 participants in each group, all women, (mean age 24.2±3.2). Forty two percent of participants in each group were diagnosed with BN, 13% with BED, 35% with AN and 10% with ARFID. Thirty percent of participants in each group, also met criteria for borderline personality disorder on the SCID-II .The overall sample had predominantly high socioeconomic status.
Each therapist received a written consent from 8 to 9 clients to participate in the study and record all sessions. The research student, who collected the data was blind to treatment groups. Therapists and participants were blinded to the research aims and hypothesis.
In the intervention group, therapist received mentalization-based supervision along all participants' treatments, with the suggested tool and facilitated mentalization-focused therapy. The control group's participants received ITP-interpersonal psychotherapy that focused on resolving interpersonal problems and symptomatic recovery. The control group's therapist received regular supervision - with no emphasis on mentalization or tool's usage.
Participants' sessions were recorded over 12 months of treatment. Four randomized samples for each participant were checked for therapy-focused fidelity by two different psychotherapist Measures All participants underwent on entry a standard assessment of eating disorder, including a semi structured interview to measure co-morbid disorders, by experienced psychologist. Participants in both groups completed the Eating Attitudes Test (EAT-26) and the Reflective Functioning Questionnaire RFQ as part of a larger assessment battery.
The EAT-26 is a self-administered questionnaire that reveals abnormal eating behaviors. It consists of 26 items with six components scored from 0 to 3 (Zero: "Never," "Rarely," and "Sometimes"; 1: "Often"; 2: "Very often"; and 3: "Always"). The total score range from 0 to 78, and a score ≥ 20 is considered to represent abnormal eating attitudes or behaviors. The Cronbach's alpha in this study ranged between 0.75-0.90.
The RFQ was developed as a brief, easy-to-administer screening measure to assess severe impairments or imbalances in mentalization capacities. It includes 8 items scaled on 7-point Likert-type scale scored from 0 to 3. High values on this scale indicate high uncertainty about mental states, hence difficulties with mentalizing. The Cronbach's alpha in this study ranged between 0.8-0.94.
Statistical analysis All analyses were conducted using SPSS 23®. Normality distributions and outliers for each outcome variable were examined prior to commencing analysis. Independent T-tests analysis was used to assess differences between groups at baseline and between groups' improvements. Paired T-tests within each group used to assess the improvement between baseline, and 12 months treatment. Pearson correlations were computed to assess the relationship between change in eating disorder's symptoms and change in mentalizing capacities.
- Conditions
- Eating Disorders
- Being tested
- Mentalization -based therapy using novel tool to demonstrate eating behavior and control axis
- Keywords
- eating disorders, self-regulation, self-control, Mentalization
- Medical subject headings
- Feeding and Eating Disorders, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentalization -based therapy using novel tool to demonstrate eating behavior and control axisOther
Also called IPT - interpersonal psychotherapy
To address the gap between theory and practice in the treatment of eating disorders we y developed a novel axis, ECOSA, to better conceptualize the complex interaction between eating style, control conditions, and the impact of the "emotional brain" versus the "thinking brain". A randomized pilot study was used to evaluate the integration of this tool in a mentalization-based treatment compared to treatment as usual (IPT).
Methods: The suggested tool was tested in a randomized blinded feasibility study using the Eating Attitudes Test (EAT-26) and the Reflective Functioning Questionnaire RFQ - as the main outcome.
| Study group | Role | What they receive |
|---|---|---|
| Mentalization-based Intervention | Experimental | Participants in the intervention group, received mentalization-based psychotherapy with the developed ECOSA axis. Therapist received mentalization-based supervision. Receives: Other: Mentalization -based therapy using novel tool to demonstrate eating behavior and control axis |
| IPT-Inter Personal Therapy | Active comparator | The control group's participants received IPT - interpersonal psychotherapy that focused on resolving interpersonal problems and symptomatic recovery. The control group's therapist received regular supervision - with no emphasis on mentalization or tool's usage. Receives: Other: Mentalization -based therapy using novel tool to demonstrate eating behavior and control axis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reflective Functioning Questionnaire RFQ
The RFQ was developed as a brief, easy-to-administer screening measure to assess severe impairments or imbalances in mentalization capacities. It includes 8 items scaled on 7-point Likert-type scale scored from 0 to 3. High values on this scale indicate high uncertainty about mental states, hence difficulties with mentalizing (Fonagy, Luyten, Moulton-Perkins, Lee, Warren et al, 2016). The Cronbach's alpha in this study ranged between 0.8-0.94.
Measured: 1 year
Eating Attitudes Test (EAT-26)
The EAT-26 is a self-administered questionnaire that reveals abnormal eating behaviors. It consists of 26 items with six components scored from 0 to 3 (Zero: "Never," "Rarely," and "Sometimes"; 1: "Often"; 2: "Very often"; and 3: "Always"). The total score range from 0 to 78, and a score ≥ 20 is considered to represent abnormal eating attitudes or behaviors (Garner, 1991). The Cronbach's alpha in this study ranged between 0.75-0.90.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start2 Sep 2018
- Primary completion30 Apr 2019
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies 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
- Sequential
- Model description
- Six experienced therapists (more than 10 yrs. in the eating disorders' treatment) within one eating disorder center, were randomly allocated using the excel randomization function to the intervention group and control group. All participants in the clinical sample were drawn consecutively from admitted population to these therapists in a community-based eating disorder center between September 2018 to April 2019.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Hai College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moria Golan, Tel Hai College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433663
- Sponsor's protocol ID
- TelHaiC
- Status last verified
- Oct 2020
- First submitted
- 31 May 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All names and identification data will be omitted from the file that will be sent to statistical assessments.
Publications
Fonagy, P., Gergely, G., Jurist, E. L., & Target, M. (2018). Affect regulation, mentalization and the development of the self. Taylor and Francis Inc. https://doi.org/10.4324/9780429471643
Fonagy P, Luyten P, Moulton-Perkins A, Lee YW, Warren F, Howard S, Ghinai R, Fearon P, Lowyck B. Development and Validation of a Self-Report Measure of Mentalizing: The Reflective Functioning Questionnaire. PLoS One. 2016 Jul 8;11(7):e0158678. doi: 10.1371/journal.pone.0158678. eCollection 2016.
PubMed 27392018Garner, D. (1991). The Eating Disorder Inventory-2: Professional Manual. Odessa, Florida: Psychological Assessment Resources.
Juarascio, A., Manasse, S., Clark, K. E., Schaumberg, K., Kerrigan, S., Goldstein, S. P., & Forman, E. (2020). Understanding the overlap and differences in terms describing patterns of maladaptive avoidance and intolerance of negative emotional states. Personality and Individual Differences. Elsevier Ltd. https://doi.org/10.1016/j.paid.2020. 109859.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eating Disorders, Emotion Regulation, and Mentalization: Addressing the Gap Between Theory and Practice
- ClinicalTrials.gov ID
- NCT04433663
- Acronym / sponsor ID
- TelHaiC
- Conditions
- Eating Disorders
- Keywords
- eating disorders, self-regulation, self-control, Mentalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Tel Hai CollegeUniversity, hospital or other
- Study start
- 2 Sep 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 16 Jun 2020 (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.
A randomized blinded feasibility study using the Eating Attitudes Test (EAT-26) and the Reflective Functioning Questionnaire RFQ - as the main outcome to assess two interventions for eating disorders. Six experienced therapists, and their consecutively 8-9 admitted clients, were randomly allocated to the intervention group and control group. The sample included a total of 52 participants, all women, mean age 24.2 yrs. old. In the intervention group, participants received mentalization-based psychotherapy with ECOSA - a novel developed mentalization tool and in the control group, participants received interpersonal psychotherapy that focused on resolving interpersonal problems and symptomatic recovery. Four randomized samples for each participant were checked for therapy-focused fidelity by two different psychotherapists.
Detailed description
Six experienced therapists (more than 10 yrs. in the eating disorders' treatment) within one eating disorder center, were randomly allocated using the excel randomization function to the intervention group and control group. All participants in the clinical sample were drawn consecutively from admitted population to these therapists in a community-based eating disorder center between September 2018 to April 2019. The sample (total of 52 patients) included 26 participants in each group, all women, (mean age 24.2±3.2). Forty two percent of participants in each group were diagnosed with BN, 13% with BED, 35% with AN and 10% with ARFID. Thirty percent of participants in each group, also met criteria for borderline personality disorder on the SCID-II .The overall sample had predominantly high socioeconomic status.
Each therapist received a written consent from 8 to 9 clients to participate in the study and record all sessions. The research student, who collected the data was blind to treatment groups. Therapists and participants were blinded to the research aims and hypothesis.
In the intervention group, therapist received mentalization-based supervision along all participants' treatments, with the suggested tool and facilitated mentalization-focused therapy. The control group's participants received ITP-interpersonal psychotherapy that focused on resolving interpersonal problems and symptomatic recovery. The control group's therapist received regular supervision - with no emphasis on mentalization or tool's usage.
Participants' sessions were recorded over 12 months of treatment. Four randomized samples for each participant were checked for therapy-focused fidelity by two different psychotherapist Measures All participants underwent on entry a standard assessment of eating disorder, including a semi structured interview to measure co-morbid disorders, by experienced psychologist. Participants in both groups completed the Eating Attitudes Test (EAT-26) and the Reflective Functioning Questionnaire RFQ as part of a larger assessment battery.
The EAT-26 is a self-administered questionnaire that reveals abnormal eating behaviors. It consists of 26 items with six components scored from 0 to 3 (Zero: "Never," "Rarely," and "Sometimes"; 1: "Often"; 2: "Very often"; and 3: "Always"). The total score range from 0 to 78, and a score ≥ 20 is considered to represent abnormal eating attitudes or behaviors. The Cronbach's alpha in this study ranged between 0.75-0.90.
The RFQ was developed as a brief, easy-to-administer screening measure to assess severe impairments or imbalances in mentalization capacities. It includes 8 items scaled on 7-point Likert-type scale scored from 0 to 3. High values on this scale indicate high uncertainty about mental states, hence difficulties with mentalizing. The Cronbach's alpha in this study ranged between 0.8-0.94.
Statistical analysis All analyses were conducted using SPSS 23®. Normality distributions and outliers for each outcome variable were examined prior to commencing analysis. Independent T-tests analysis was used to assess differences between groups at baseline and between groups' improvements. Paired T-tests within each group used to assess the improvement between baseline, and 12 months treatment. Pearson correlations were computed to assess the relationship between change in eating disorder's symptoms and change in mentalizing capacities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Six experienced therapists (more than 10 yrs. in the eating disorders' treatment) within one eating disorder center, were randomly allocated using the excel randomization function to the intervention group and control group. All participants in the clinical sample were drawn consecutively from admitted population to these therapists in a community-based eating disorder center between September 2018 to April 2019.
| Arm | Type | Receives |
|---|---|---|
| Mentalization-based Intervention | Experimental | Other: Mentalization -based therapy using novel tool to demonstrate eating behavior and control axisParticipants in the intervention group, received mentalization-based psychotherapy with the developed ECOSA axis. Therapist received mentalization-based supervision. |
| IPT-Inter Personal Therapy | Active comparator | Other: Mentalization -based therapy using novel tool to demonstrate eating behavior and control axisThe control group's participants received IPT - interpersonal psychotherapy that focused on resolving interpersonal problems and symptomatic recovery. The control group's therapist received regular supervision - with no emphasis on mentalization or tool's usage. |
Who may qualify
- Ages
- 17 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Participants were previously diagnosed with eating disorder (Eat-26>21)
- 17 yrs age and older
- no acute suicidality
- no physical risks due to eating disorder's symptoms
Key exclusion criteria (3 listed)
- age <17 yrs old
- refusal to corporate with treatment
- Need of 24 hrs medical care
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 |
|---|---|---|
| Mentalization -based therapy using novel tool to demonstrate eating behavior and control axisAlso: IPT - interpersonal psychotherapyTo address the gap between theory and practice in the treatment of eating disorders we y developed a novel axis, ECOSA, to better conceptualize the complex interaction between eating style, control conditions, and the impact of the "emotional brain" versus the "thinking brain". A randomized pilot study was used to evaluate the integration of this tool in a mentalization-based treatment compared to treatment as usual (IPT). Methods: The suggested tool was tested in a randomized blinded feasibility study using the Eating Attitudes Test (EAT-26) and the Reflective Functioning Questionnaire RFQ - as the main outcome. | Other | IPT-Inter Personal Therapy, Mentalization-based Intervention |
Primary outcome
Reflective Functioning Questionnaire RFQ
Time frame: 1 year
The RFQ was developed as a brief, easy-to-administer screening measure to assess severe impairments or imbalances in mentalization capacities. It includes 8 items scaled on 7-point Likert-type scale scored from 0 to 3. High values on this scale indicate high uncertainty about mental states, hence difficulties with mentalizing (Fonagy, Luyten, Moulton-Perkins, Lee, Warren et al, 2016). The Cronbach's alpha in this study ranged between 0.8-0.94.
Eating Attitudes Test (EAT-26)
Time frame: 1 year
The EAT-26 is a self-administered questionnaire that reveals abnormal eating behaviors. It consists of 26 items with six components scored from 0 to 3 (Zero: "Never," "Rarely," and "Sometimes"; 1: "Often"; 2: "Very often"; and 3: "Always"). The total score range from 0 to 78, and a score ≥ 20 is considered to represent abnormal eating attitudes or behaviors (Garner, 1991). The Cronbach's alpha in this study ranged between 0.75-0.90.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- BackgroundFonagy, P., Gergely, G., Jurist, E. L., & Target, M. (2018). Affect regulation, mentalization and the development of the self. Taylor and Francis Inc. https://doi.org/10.4324/9780429471643
- Background: PubMed 27392018Fonagy P, Luyten P, Moulton-Perkins A, Lee YW, Warren F, Howard S, Ghinai R, Fearon P, Lowyck B. Development and Validation of a Self-Report Measure of Mentalizing: The Reflective Functioning Questionnaire. PLoS One. 2016 Jul 8;11(7):e0158678. doi: 10.1371/journal.pone.0158678. eCollection 2016.
- BackgroundGarner, D. (1991). The Eating Disorder Inventory-2: Professional Manual. Odessa, Florida: Psychological Assessment Resources.
- BackgroundJuarascio, A., Manasse, S., Clark, K. E., Schaumberg, K., Kerrigan, S., Goldstein, S. P., & Forman, E. (2020). Understanding the overlap and differences in terms describing patterns of maladaptive avoidance and intolerance of negative emotional states. Personality and Individual Differences. Elsevier Ltd. https://doi.org/10.1016/j.paid.2020. 109859.
- Individual participant dataSharing planned: No. All names and identification data will be omitted from the file that will be sent to statistical assessments.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Eating Disorders, run by Tel Hai College at 1 site in Israel.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reflective Functioning Questionnaire RFQ (time frame: 1 year). The study lists 2 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 NCT04433663, which also lists 4 linked publications.
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 8 Oct 2020.