Clinical trial NCT04101032: eBEfree - an ICT Adaptation of BEfree
Official title: eBEfree - an ICT Adaptation of BEfree: an APP Delivered Programme Based on Mindfulness, Values, and Compassion for Binge Eating
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Binge-Eating Disorder
Keywords: Mindfulness
Self-compassion
Values
Binge Eating
Lead sponsor: University of Coimbra
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The eBEfree project aims at testing the effectiveness of an information and communication technology-based delivery version of BEfree in individuals with obesity and Binge Eating Disorder (BED). BED is a serious public health concern, given its prevalence, psychiatric comorbidity and association with obesity, which is currently a major health and economic challenge of epidemic proportions. BED affects obesity onset, maintenance and treatment. BEfree is a 12-session face-to-face group intervention for BED, developed by the current project research team, that integrates mindfulness, compassion, and values. BEfree was found to be effective in treating BED and in improving psychological adjustment. ICT-based interventions are a cost-effective form of treatment delivery that may increase treatment accessibility for individuals with BED and obesity. This project will directly contribute to the treatment of these conditions and improvement of health services at regional and national levels.

Detailed description: The current project aims at developing a mobile-app adapted version of BEfree - eBEfree - as well as test the efficacy of this ICT-delivery version in a sample of participants with obesity and BED. The specific objectives of the project are:

1. Develop an ICT-delivery version of BEfree: eBEfree.
2. Examine the effectiveness of the ICT-delivery version eBEfree.
3. Test the stability of the outcomes over 6 months.
4. Compare the effectiveness of the eBEfree and the face-to-face version of BEfree.
5. Analyse eBEfree cost-effectiveness.

A detailed description of the aims of the project are presented below.

1. Developing the ICT-delivery version of BEfree - eBEfree. This toolkit will be developed based on the original manual of the face-to-face version of BEfree and will include the tools targeted in BEfree to support participants in reducing BE symptomatology and improve psychological well-being. These tools will cover three main areas:

   i) Mindfulness skills to promote adaptive emotion regulation and improve eating behaviour regulation; ii) Compassion skills to promote motivation that supports sustained adaptive behaviour regulation.

   iii) The development of psychological flexibility and the promotion of values-based living; The techniques of each area will be implemented sequentially in a portfolio of ICT-enabled tools, including a platform with multimedia resources (e.g. videos of sessions) and mobile applications to promote the engagement of users. User evaluation of the platform will be measured using data collected by the mobile application (using metrics like usage time, sessions attended, among others) and through the intervention feedback questionnaire.
2. Examining the effectiveness of the ICT-delivery version eBEfree, through a 2 x 2 factorial Randomized Clinical Trial (RCT) in 70 participants: eBEfree intervention vs. Waiting List Condition (WLC). Primary outcomes are: reductions in BE symptoms and other disordered eating and body image symptoms. Secondary outcomes: Weight loss outcomes; reductions in depressive symptoms and improvements in wellbeing. Mediators of the effectiveness of the ICT-delivery version eBEfree: increases in self-compassion, mindfulness, engagement with valued living, body image psychological flexibility; and decreases in shame, self-criticism and body image-cognitive fusion. Moderators of the intervention: eBEfree engagement (i.e., frequency of mindfulness and compassion meditation practices and daily tasks).
3. Examining the stability of the outcomes measured at 3 and 6 months.
4. Comparing the effectiveness of the eBEfree and the face-to-face version of BEfree, through a 2 x 2 factorial nonrandomized controlled intervention. This aim will be achieved by comparing results from participants who complete the eBEfree intervention and data obtained in the original project BEfree (PTDC/MHC-PCL/4923/2012.).
5. Analysing the cost-effectiveness of the eBEfree by comparing intervention formats: TAU for BED in patients with obesity vs. BEfree, and BEfree vs. eBEfree.

The eBEfree toolkit will include the same components as the original BEfree intervention organized in sequential modules, that will provide psychoeducation of the maintenance cycle of BE, will introduce compassion and mindfulness practices, and will promote psychological flexibility and engagement in values-based actions. A detailed description of each module is provided in Pinto-Gouveia et al. (2016).

The eBEfree will emphasize experiential mindfulness and compassion practices, and daily self-monitoring (i.e., eating behaviour, physical activity). To maximize adherence weekly emails will be sent to participants to prompt engagement with the platform. EBEfree will also include a web-based discussion forum to promote group support and discussion.

Participants Inclusion criteria: a) age: 18-55; b) overweight and obesity (IMC ≥ 25 using a Body Mass Analyzer TANITA-SC-330); c) BED (confirmed through the Eating Disorder Examination 17.0D; d) access to smartphone and willingness to use it regularly (at least once a week).

Exclusion criteria: a) undergoing any other form of psychological intervention for BED or having attended the face-to-face BEfree; b) severe psychiatric problem (e.g., major depression; psychotic illness; bipolar disorder, assessed through a semi-structured interview using DSM-5 criteria).

Results from G\*Power calculations for within-group repeated measures analysis, assuming a p value = 0.05, an effect size of f = 0.5, with a statistical power of 0.95, recommend a sample size of 54. Assuming a 20-30% drop-out rate, the minimum sample will be N = 70.

Procedure The sample will be recruited through the dissemination of the study in public health services in the central region of Portugal covered by the Health Centre Regional Administration \[Administração Regional de Saúde do Centro - ARSC, IP\], a key partner of the project. The study will also be disseminated by the Association of obese and ex-obese patients of Portugal (Associação de Doentes Obesos e Ex-obesos de Portugal, ADEXO) among its members and through its website, which has ≅ 300 daily visits. ADEXO is a nation-wide organization, that promotes the treatment and prevention of obesity. The study will also be advertised in national media outlets.

The advertisement will include a brief description of the project and RT contacts. After contacting the RT, participants will be required to provide informed consent and will be sent a link (through QRCode in flyers or other means) to the eBEfree platform for an online questionnaire to assess eligibility criteria in a first screening phase: age (18-55), self-reported weight status; BE symptomatology (using the Binge Eating Scale cut-off score of \> 17); severe depressive symptomatology (using the Beck Depression Inventory cut-off score of \> 30); access to smartphone and willingness to use it. If these initial eligibility criteria are met, an individual face-to-face meeting (in the research unit CINEICC), will be scheduled to assess the inclusion criteria described above. Those who meet all inclusion will answer to a set of self-report online questionnaires (3 to 10 presented below) and will be randomly assigned to one of two conditions: eBEfree or WLC. Participants´ responses will be directly sent to a data hub that only the RT will have access to. Those who met criteria for an excluding psychiatric condition will be advised to contact mental health services indicated by the RT. Participants allocated to the eBEfree condition will have access to the eBEfree platform and will be invited to complete eBEfree over the following 12 weeks. After completing the programme participants will be asked to attend an individual face-to-face post intervention assessment where they will be assessed through the EDE 16.0D and the same set of online self-report questionnaires and a post-intervention qualitative feedback questionnaire. Engagement with the online platform data (e.g., practice frequency) will be recorded in the data hub over the 12 weeks of programme completion. Follow-up assessments through online self-report measures (1-10 and self-reported weight) will be conducted at 3 and 6 months.

Participants in the WLC will also complete all assessments and afterwards will be given the opportunity to complete the eBEfree.

Eligibility criteria: Inclusion Criteria:

* overweight and obesity (IMC ≥ 25 using a Body Mass Analyzer TANITA-SC-330);
* BED (confirmed through the Eating Disorder Examination 17.0D;
* Access to smartphone and willingness to use it regularly (at least once a week).

Exclusion Criteria:

* undergoing any other form of psychological intervention for BED or having attended the face-to-face BEfree;
* severe psychiatric problem (e.g., major depression; psychotic illness; bipolar disorder, assessed through a semi-structured interview using DSM-5 criteria).

Primary outcomes:
measure: Reductions in BE symptoms and other disordered eating and body image symptoms
timeFrame: 9 months (from baseline to 6 months follow-up)
measure: Reductions in BE symptoms and other disordered eating and body image symptoms
timeFrame: 9 months (from baseline to 6 months follow-up)
Secondary outcomes:
measure: Weight loss
timeFrame: 9 months (from baseline to 6 months follow-up)
measure: Reductions in depressive symptoms
timeFrame: 9 months (from baseline to 6 months follow-up)
measure: Increasing well-being
timeFrame: 9 months (from baseline to 6 months follow-up)
Other outcomes:
measure: Increase in self-compassion
timeFrame: 9 months (from baseline to 6 months follow-up)
measure: Increase in mindfulness
timeFrame: 9 months (from baseline to 6 months follow-up)
measure: Increase in engagement with valued living
timeFrame: 9 months (from baseline to 6 months follow-up)
measure: Increase in body image psychological flexibility
timeFrame: 9 months (from baseline to 6 months follow-up)
measure: Decrease in shame
timeFrame: 9 months (from baseline to 6 months follow-up)
measure: Decrease in self-criticism
timeFrame: 9 months (from baseline to 6 months follow-up)
measure: Decrease in body-image cognitive fusion
timeFrame: 9 months (from baseline to 6 months follow-up)
Locations:
Study officials:
affiliation: University of Coimbra
name: José Augusto Pinto Gouveia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pinto-Gouveia J, Carvalho SA, Palmeira L, Castilho P, Duarte C, Ferreira C, Duarte J, Cunha M, Matos M, Costa J. Incorporating psychoeducation, mindfulness and self-compassion in a new programme for binge eating (BEfree): Exploring processes of change. J Health Psychol. 2019 Mar;24(4):466-479. doi: 10.1177/1359105316676628. Epub 2016 Nov 15.
citation: Pinto-Gouveia J, Carvalho SA, Palmeira L, Castilho P, Duarte C, Ferreira C, Duarte J, Cunha M, Matos M, Costa J. BEfree: A new psychological program for binge eating that integrates psychoeducation, mindfulness, and compassion. Clin Psychol Psychother. 2017 Sep;24(5):1090-1098. doi: 10.1002/cpp.2072. Epub 2017 Jan 25.