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临床试验/NCT01394393
NCT01394393Unknown1 期

Ambientes Virtuales Como Auxiliares en el Tratamiento de la Obesidad

Universidad Nacional Autonoma de Mexico1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年1月1日最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
40
试验地点
1
主要终点
Anxiety Inventory: State-Trait IDARE

研究概览

简要总结

Participants 60 Patients seeking treatment at the Obesity Unit of the Medica Sur Hospital in México City, Mexico. Informed consent to participate will be aleatory assigned to a three different conditions.

Procedures In the initial interview, prospective participants will be provided with detailed information about the study and the treatments. All patients included in the study will be randomly assigned to the one (N=20) of the three treatment conditions described below, all conducted on an inpatient basis. The duration for all treatments will be 6 weeks and will be administered by two chartered clinical psychologists and one chartered psychotherapist under the supervision of a senior chartered psychotherapist. The three therapists will be balanced among the three conditions.

  1. Nutritional groups In this condition (NT) the participants (N=20) subjects enter only 5 weekly nutritional groups held by dieticians based on the LEARN manual (Brownell, 1985), whose goal will be to provide practical guidelines for the self-monitoring of eating and lessons on nutrition (e.g stressing gradual weight loss with the caloric restriction achieved largely by reductions in fat intake), plus a low-calorie diet (1,200 kcal/day) and physical training (30 min of walking two times a week as a minimum).
  2. Cognitive-Behavioral therapy CBT group (N=20) will be based on the same treatment proposed in the first condition plus 15 additional sessions over 6 weeks.

Therapists will follow a detailed manual that outlined the content of each session. This manual was based on the cognitive-behavioral treatment approach described by Cooper and colleagues (Cooper & Fairburn, 2002; Cooper et al., 2003). It was developed during a year of intensive pilot work and adapted to the in-patient setting. Patients will be taught to self-monitor their food intake and eating patterns and thoughts, as well as the circumstances and environment surrounding eating (e.g. whether eating alone or with others, speed of eating, and place of eating). Patients will also be taught to identify problems in eating, mood, and thinking patterns and to gradually develop alternative patterns.

In particular, after the first week the patients will enter 5 weekly group sessions aimed at addressing weight and primary goals, and 10 biweekly individual sessions aimed at establishing and maintaining weight loss, addressing barriers to weight loss, increasing activity, addressing body image concerns and supporting weight maintenance. 3. Experiential Cognitive therapy Experiential CT group (N=4) involved the same treatment proposed in the first condition plus 15 additional sessions over 4/6 weeks.

In the sessions we will use the "20/20/20 rule". During the first 20 minutes, the therapist focus on getting a clear understanding of the patient's current concerns, level of general functioning, and the experiences related to food. This part of the session tends to be characterized by patients doing most of the talking, although therapist guides with questions and reflection to get a sense of the patient's current status. The second 20 minutes is devoted to the virtual reality experience. During this part of the session the patient enters the virtual environment and faces a specific critical situation (Kitchen, Supermarket, Pub, Restaurant, Gymnasium, etc.). Here the patient is helped in developing specific strategies for avoiding and/or coping with it. In the final 20 minutes the therapist explores the patient's understanding of what happened in VR and the specific reactions - emotional and behavioral - to the different situations experienced. If needed, some new strategies for coping with the VR situations are presented and discussed. To support the empowerment process, the therapists follow the Socratic style: they use a series of questions, related to the contents of the virtual environment, to help clients synthesize information and reach conclusions on their own.

In accordance with informed consent, assessments will be obtained before treatment, at posttreatment, 3 and 6 months after the treatment conclusion.

详细描述

In the initial interview, prospective participants will be provided with detailed information about the study and the treatments. All patients included in the study will be randomly assigned to the waiting-list group and to the one of the three treatment conditions described below, all conducted on an inpatient basis. The duration for all treatments will be 6 weeks and will bw administered by two chartered clinical psychologists and one chartered psychotherapist under the supervision of a senior chartered psychotherapist. The three therapists will bw balanced among the three conditions. In accordance with informed consent, assessments will be obtained before treatment, at posttreatment, 3 and 6 months follow up after the end of treatment.

  1. Nutritional groups In this condition (NT) the subjects enter only 5 weekly nutritional groups held by dieticians based on the LEARN manual (Brownell, 1985), whose goal will be to provide practical guidelines for the self-monitoring of eating and lessons on nutrition (e.g stressing gradual weight loss with the caloric restriction achieved largely by reductions in fat intake), plus a low-calorie diet (1,200 kcal/day) and physical training (30 min of walking two times a week as a minimum).

2 Cognitive-Behavioral therapy CBT will be based on the same treatment proposed in the first condition plus 15 additional sessions over 6 weeks. Therapists will follow a detailed manual that outlined the content of each session. This manual was based on the cognitive-behavioral treatment approach described by Cooper and colleagues (Cooper & Fairburn, 2002; Cooper et al., 2003). It was developed during a year of intensive pilot work and adapted to the in-patient setting. Patients will be taught to self-monitor their food intake and eating patterns and thoughts, as well as the circumstances and environment surrounding eating (e.g. whether eating alone or with others, speed of eating, and place of eating). Patients will also be taught to identify problems in eating, mood, and thinking patterns and to gradually develop alternative patterns. In particular, after the first week the patients will enter 5 weekly group sessions aimed at addressing weight and primary goals, and 10 biweekly individual sessions aimed at establishing and maintaining weight loss, addressing barriers to weight loss, increasing activity, addressing body image concerns and supporting weight maintenance.

  1. Experiential Cognitive therapy In particular, after the first week the patients entered 5 weekly group sessions aimed at improving motivation to change and assertiveness, and 10 biweekly virtual reality sessions. For the VR sessions, the NeuroVR 1.5 software will be used. NeuroVR is an enhanced version of the original Virtual Reality for Body Image Modification (VEBIM) immersive virtual environment, previously used in different preliminary studies on non-clinical subjects (Riva, 1997a, 1998b). Is composed of 14 virtual environments, used by the therapist within a 60-minute session with the patient. The environments present critical situations related to the maintaining/relapse mechanisms (Home, Supermarket, Pub, Restaurant, Swimming Pool, Beach, Gymnasium) and two body image comparison areas.

Using the NeuroVR Editor, the psychological stimuli/stressors appropriate for any given scenario can be chosen from a rich database of 2D and 3D objects, and easily placed into the pre-designed virtual scenario by using an icon-based interface (no programming skills are required). In addition to static objects, the NeuroVR Editor allows both to add audio object and to overlay on the 3D scene video composited with a transparent alpha channel.The editing of the scene is performed in real time, and effects of changes can be checked from different views (frontal, lateral and top).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients seeking treatment at the Obesity Unit of the Hospital Medica Sur, Mexico City, Mexico
  • a Body Mass Index higher than 40;
  • written and informed consent to participate.

排除标准

  • other concurrent severe psychiatric disturbances (psychosis, depression with suicidal risk, alcohol or drug abuse);
  • concurrent medical condition not related to the disorder;
  • one or more failures in following an obesity treatment.

结局指标

主要结局

Anxiety Inventory: State-Trait IDARE

时间窗: Change from Baseline in Anxiety Inventory: State-Trait IDARE at 6 weeks, Change from Baseline in Anxiety Inventory: State-Trait IDARE at 6 months

The scale A-Trait Anxiety Inventory consists of twenty statements in which subjects are asked to describe how they feel generally. A-State scale also consists of 20 statements, but the instructions required that subjects indicate how they feel at any given time. Measures two dimensions of anxiety: state (referring to how the subject feels at that moment) and trait (how you feel usually). Instrument validated in Mexico (Spielberger \& Diaz Guerrero, 1975)

Body Image Questionnaire (BSQ)

时间窗: Change frome Baseline in Body Image Questionnaire (BSQ) at 6 weeks, Change frome Baseline in Body Image Questionnaire (BSQ) at 6 months

Designed by Cooper, Taylor, Cooper and Fairburn (1987), adapted to Spanish population by Raich et al. (1996) and to Mexican women by Galán (2004). Consists of 34 questions scored on a Likert scale of 1 to 6. Lets get an overall score (sum of raw scores of the items) and can be derived 4 subscales: body dissatisfaction, fear of gaining weight, low esteem by the appearance and want to lose weight.

Weight

时间窗: Changes in weight from de first week will be assessed up to 6 weeks, changes in weight at 6 months

Weight loss after the treatment and after the follow-up phase

次要结局

  • BULIT Bulimia Test(Change from Baseline in BULIT Bulimia Test at 6 weeks, Change from Baseline in BULIT Bulimia Test at 6 months)
  • Three Food Factors Questionnaire (TFEQ)(Change from Baseline in Three Food Factors Questionnaire (TFEQ) at 6 weeks, Change from Baseline in Three Food Factors Questionnaire (TFEQ) at 6 months)
  • Opinion on exposure therapy(Opinion on exposure therapy at 6 weeks)

研究者

发起方
Universidad Nacional Autonoma de Mexico
申办方类型
Other
责任方
Principal Investigator
主要研究者

DRA. GEORGINA CARDENAS LOPEZ

Full time professor

Universidad Nacional Autonoma de Mexico

研究点 (1)

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