Tratamiento de la Bulimia Nerviosa Mediante exposición a señales Con Realidad Virtual
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Change from baseline in food craving on the FCQ-T/S (Food Craving Questionnaire-Trait/State) at the end of the treatment and at six months follow-up
研究概览
简要总结
Introduction: The purpose of this research is to develop a new component for cognitive-behavioral treatment (CBT), empirically validated, for binge eating behavior in patients with bulimia nervosa (BN) and binge eating disorder (BED), by means of cue-exposure therapy (CET) with virtual reality. While CBT is an effective treatment for these eating disorders, an important percentage of patients do not improve despite treatment. It is necessary to explore how to enhance the effectivity of usual treatments with the incorporation of new technologies and procedures. The innovation of this investigation is based on the use of VR for cue-exposure therapy, which has been found effective with patients resistant to conventional treatments (CBT and pharmacological intervention), and seeks to enhance this efficacy by increasing possibilities of generalization and providing more useful tools to clinicians, diminishing the logistic complications of the exposure to real cues (food).
Participants: 60 patients with a diagnosis of BN or BED according the DSM-5 who had been proposed for participation in the study by their referral mental health's professional after conducting unsuccessfully a first level treatment (CBT structured intervention) at the clinical sites involved will participate in the study.
Procedure: Participants with active episodes of binge eating (and purging, in the case of BN) during the last 2 weeks of the structured intervention of CBT will be provided with detailed information about the study. All patients who agree to participate in the study and who sign the informed consent form will be randomly assigned to one of the two second-level treatment conditions: virtual reality based cue-exposure therapy (VR-CET) or additional cognitive-behavioral treatment (A-CBT). Both second-level treatment conditions consist of six 60-minute sessions that are held two times per week over a period of three weeks.
In an interview setting, all of the participants will be administered several questionnaires (BN, DT and BD subscales of EDI-3, FCQ-T/S, and STAI-Y) and participants assigned to the VR-CET will also be exposed to various types of virtual foods in different virtual environments (kitchen, dining-room, bedroom, and café) where they will be asked about their food cravings and anxiety experienced in each situation to develop a proper exposure hierarchy according to the specific characteristics and needs of each patient.
详细描述
Sample Sixty patients who have been diagnosed with BN or BED according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) and who have been found to be resistant to an initial structured program of CBT (Fairburn, Marcus, & Wilson, 1993) will participate in the study. Participants will be recruited from collaborating hospitals and health centers including Hospital de Bellvitge (Barcelona, Spain), Adult Mental Health Center of the Consorcio Sanitario de la Anoia (Igualada, Spain), Hospital Universitari Joan XXIII (Tarragona, Spain), Centro ABB (Tarragona, Spain) and the Instituto Auxologico Italiano (Milano, Italy). Suicidal ideation and diagnoses of other severe mental disorders (substance use disorders, bipolar disorder, psychosis) are exclusion criteria. Patients with active episodes of binge eating (and purging, in case of BN) during the last two weeks of the structured program of CBT will be considered for participation in the study. All prospective participants will be comprehensively informed about the characteristics of the study and will be required to sign an informed consent form. Authorization of the research ethics committees of the applicant organization (University of Barcelona) and the collaborating institutions will be required.
Patients who agree to participate in the study will be randomly assigned to one of two second-level treatment conditions: the VR-CET group will receive cue-exposure sessions using VR environments (six 60-minute (maximum) sessions over the course of three weeks; two per week) and the A-CBT group will receive six additional sessions of the usual cognitive behavioral treatment. Consistent with the American Psychological Association and the CONSORT guideline recommendations regarding sample size in this type of research, 30 patients will be included in each group. If necessary, dropout cases will be replaced.
Procedure At the end of the first level of treatment with the structured program of CBT, all patients will be assessed relative to their status and will complete several questionnaires (BN, DT and BD subscales of EDI-3, FCQ-T/S, and STAI-Y) (pre-randomization assessment).
Those with active behavioral symptoms who agree to participate in the intervention study and who have signed the informed consent form will be randomly assigned to one of the two second-level treatment conditions: VR-CET or A-CBT sessions. Also, participants assigned to the VR-CET condition will be assessed through a validated VR-based cue exposure software (Gutiérrez-Maldonado, Pla-Sanjuanelo et al., 2016) in order to construct the exposure hierarchy of 3D interactive (environment and food) situations, used in the VR-CET sessions. For that, participants assigned to the VR-CET condition:
- Will be exposed to 30 graphic representations of different foods. The level of craving elicited by each food will be assessed by means of a visual analog scale (VAS) that ranges from 0 (not at all) to 100 (extreme).
- These participants will also be exposed to four graphic representations of different environments (kitchen, dining room, bedroom, and café). The level of craving elicited by each environment will be assessed by means of a VAS that ranges from 0 (not at all) to 100 (extreme).
- They will be individually exposed to the ten different virtual foods assessed as eliciting the highest levels of craving in each of the four virtual environments (kitchen, dining room, bedroom, and café) for a total of 40 virtual situations from lowest to highest craving scores as previously registered in phases 1 and 2. Once in the virtual situation, the participant will be asked to sit at a virtual table where the food is placed. Once the participant sits, the time is measured. During the first 20 seconds, the patient can handle the virtual food by means of the laptop's mouse but cannot eat the food. When time runs out, the levels of craving and anxiety will be assessed by means of visual analog scales that range from 0 (not at all) to 100 (extreme). Virtual environments will be displayed by means of a 3D laptop with specific software that is capable of creating a stereoscopic effect that is duly processed by polarized glasses. Headphones will also be used. This assessment will be conducted in a quiet darkened room to increase the participant's immersion in the virtual scenarios. The therapist will remain behind the patient during the assessment so as not to interfere with the task but to be available in the event a participant requires assistance.
- Anxiety scores obtained from each of the 40 situations will be used to develop the exposure hierarchy that will be used in the VR-CET sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of bulimia nervosa or binge eating disorder according the DSM-5
- •Written and informed consent to participate
排除标准
- •Other concurrent severe mental disorders (substance use disorders, bipolar disorder, psychosis)
- •Suicidal ideation
结局指标
主要结局
Change from baseline in food craving on the FCQ-T/S (Food Craving Questionnaire-Trait/State) at the end of the treatment and at six months follow-up
时间窗: Baseline (one assessment session before to the first second-level treatment session), week 3 (at the end of the last treatment session), and at the six-month follow-up
Change from baseline in eating disorders symptomatology on the BN, DT and BD subscales of EDI-3 (Eating Disorders Inventory-3), at the end of the treatment and at six month follow-up
时间窗: Baseline (one assessment session before to the first second-level treatment session), week 3 (at the end of the last treatment session), and at the six-month follow-up
Change from baseline in the frequency of binging and purging episodes using self-reports at the end of the treatment and at six month follow-up
时间窗: Baseline (daily along the two weeks before to the first second-level treatment session), daily along the two weeks after the last treatment session, and daily along the two weeks after six months follow-up
Binging and purging episodes will be self-registered by the participants of the two groups during the two weeks prior to beginning the second-level treatment sessions, during the two weeks after the end of the treatment sessions, and during two weeks after six-month follow-up
次要结局
- Change from baseline in anxiety on the State-Trait Anxiety Inventory at the end of the treatment and at six month follow-up(Baseline (one assessment session before to the first second-level treatment session), week 3 (at the end of the last treatment session), and at the six-month follow-up)
研究者
Jose Gutierrez Maldonado
Full Professor
University of Barcelona