Topics

eBEfree - an ICT Adaptation of BEfree

2019-09-27 06:30:40 | BioPortfolio

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.

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.

Study Design

Conditions

Binge-Eating Disorder

Intervention

eBEfree

Status

Not yet recruiting

Source

University of Coimbra

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-27T06:30:40-0400

Clinical Trials [975 Associated Clinical Trials listed on BioPortfolio]

Treatment of Binge Eating Disorder

This is a study examining the use of different degrees of therapist involvement in the treatment of Binge Eating Disorder. The study will examine both which approaches work best for decre...

Vortioxetine for Binge Eating Disorder

The aim of the present study is to examine the efficacy and safety of vortioxetine vs placebo in adults with moderate to severe Binge eating disorder, as indicated by at least 3 binge eati...

Treatment for Binge-eating Disorder

The University of Chicago is looking for women to participate in a study to evaluate the treatment options available to women living with binge eating disorder. Binge-Eating Disorder is a...

Lamotrigine in the Treatment of Binge Eating Disorder Associated With Obesity

This research study is to evaluate the effectiveness, tolerability, and safety of lamotrigine therapy in the treatment of binge eating disorder associated with obesity. Lamotrigine has be...

Uniting Couples in the Treatment of Binge-Eating Disorder

The purpose of this study is to test the feasibility, acceptability, and preliminary effectiveness of a novel couple-based intervention for binge-eating disorder (BED) relative to an estab...

PubMed Articles [5230 Associated PubMed Articles listed on BioPortfolio]

IMPULS: Impulsivity-Focused Group Intervention to Reduce Binge Eating Episodes in Patients with Binge Eating Disorder - A Randomised Controlled Trial.

Impulsivity is a risk factor for binge eating disorder, and binge eating (BE) equates to impulsive eating behaviour. Hence, we developed IMPULS, a cognitive behavioural group intervention focusing on ...

A psychometric analysis and revalidation of the Yale-Brown Obsessive Compulsive Scale modified for Binge Eating in adults with binge eating disorder.

The Yale-Brown Obsessive Compulsive Scale modified for Binge Eating (Y-BOCS-BE) assesses the obsessiveness of binge eating thoughts and compulsiveness of binge eating behaviors. The findings of this s...

Examining the Impact of Estrogen on Binge Feeding, Food-Motivated Behavior, and Body Weight in Female Rats.

Binge-eating disorder is associated with diminished self-control, emotional distress, and obesity. In this context, women are nearly twice as likely to develop binge-eating disorder and depression rel...

Dialectical behavior therapy self-help for binge-eating disorder: A randomized controlled study.

The objective of this study was to compare the relative effectiveness of dialectical behavior therapy guided self-help (DBT-GSH) and DBT unguided self-help (DBT-USH) with an unguided self-help control...

Prospective associations of negative mood and emotion regulation in the occurrence of binge eating in binge eating disorder.

Retrospective and experimental data demonstrate the importance of emotion regulation (ER) in the maintenance of binge episodes in binge eating disorder (BED). The current study tested whether mood and...

Medical and Biotech [MESH] Definitions

A disorder associated with three or more of the following: eating until feeling uncomfortably full; eating large amounts of food when not physically hungry; eating much more rapidly than normal; eating alone due to embarrassment; feeling of disgust, DEPRESSION, or guilt after overeating. Criteria includes occurrence on average, at least 2 days a week for 6 months. The binge eating is not associated with the regular use of inappropriate compensatory behavior (i.e. purging, excessive exercise, etc.) and does not co-occur exclusively with BULIMIA NERVOSA or ANOREXIA NERVOSA. (From DSM-IV, 1994)

An eating disorder that is characterized by a cycle of binge eating (BULIMIA or bingeing) followed by inappropriate acts (purging) to avert weight gain. Purging methods often include self-induced VOMITING, use of LAXATIVES or DIURETICS, excessive exercise, and FASTING.

Little or no appetite for breakfast due to eating more food after dinner than during the meal and eating more than half of daily food intake after dinner hour.

An eating disorder that is characterized by the lack or loss of APPETITE, known as ANOREXIA. Other features include excess fear of becoming OVERWEIGHT; BODY IMAGE disturbance; significant WEIGHT LOSS; refusal to maintain minimal normal weight; and AMENORRHEA. This disorder occurs most frequently in adolescent females. (APA, Thesaurus of Psychological Index Terms, 1994)

Tools used in COOKING or EATING such as cutlery, pots, pans, and dishes.

More From BioPortfolio on "eBEfree - an ICT Adaptation of BEfree"

Quick Search

Relevant Topics

Endocrinology
Diabetes Diabetes Endocrine Disorders Obesity Oxycontin Renal Disease Thyroid Disorders Endocrinology is the study of the endocrine glands and the hormones that they secrete (Oxford Medical Dictionary). There are several g...

Public Health
Alternative Medicine Cleft Palate Complementary & Alternative Medicine Congenital Diseases Dentistry Ear Nose & Throat Food Safety Geriatrics Healthcare Hearing Medical Devices MRSA Muscular Dyst...


Searches Linking to this Trial