ObesityPhase 1AVATOBNCT01394393
Virtual Environments For Supporting Obesity Treatment
A Phase 1 study testing Experiential-Cognitive Therapy for Obesity, Behavioral cognitive Treatment and Nutritional groups (NT) in people with Obesity and Morbid Obesity, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Obesity, Morbid Obesity
- What is being tested?
- Experiential-Cognitive Therapy for Obesity, Behavioral cognitive Treatment and Nutritional groups (NT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2011to Dec 2013
- Phase
- Phase 1
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Medica Sur
Mexico City, Mexico City, 14050
Gonzalo Torres-Villalobos, MD, (55)43466430, torresvgm@yahoo.com.mx
Gonzalo Torres-Villalobos, MD
About this study
Official title: Ambientes Virtuales Como Auxiliares en el Tratamiento de la Obesidad
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.
Read more
- 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).
- 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.
- 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.
Read the detailed description
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.
- 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.
- 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).
The edited scene is then visualized and experienced using the NeuroVR Player. Through the VR experience, the patients practice both eating/emotional/relational management and general decision-making and problem-solving skills. By directly practicing these skills within the VR environment, the patient is helped in developing specific strategies for avoiding and/or coping with these.
9 sessions are used to assess and modify:
- the expectations and emotions related to food and weight: This is done both by integrating different cognitive-behavioral methods: Countering, Alternative Interpretation, Label Shifting, Deactivating the Illness Belief
- the strategies used to cope with difficult interpersonal and potential maintenance situations: This is done both by using the Temptation Exposure with Response Prevention (Riva, 1998c; D. G. Schlundt \& Johnson, 1990) - and by working on these three empowering dimensions (Menon, 1999): perceived control, perceived competence and goal internalization.
- the body experience of the subject. To do this the virtual environment integrates the therapeutic methods used by Butter \& Cash (1987) and Wooley \& Wooley (1985). In particular in VREDIM we used the virtual environment in the same way as guided imagery (Leuner, 1969) is used in the cognitive and visual/motorial approach.
Structure of the sessions
Each session of Virtual Reality is divided into four phases:
The psychologist's office is the first virtual experience. It represents the start and the end of each session, and it has the important function to outline boundaries of the session in virtual reality. It is a neutral and reassuring place which allows continuity in the phases of the individual session: face to face, virtual reality and face to face.
In the psychologist's office there are the following objects: a writing-desk with two comfortable chairs, a bookshelf and complements of furnishings that make the environment more comfortable and hospitable (pictures, carpets, lamps, green plants, etc.). The safe place is the virtual experience for the relaxation that is used at the end of each session and, if needed, during the session of virtual reality. It is an empty park in which the patient can relax and recover from any emotional experience.
Between the psychologist's office and the safe place the patient experiences one or more specific virtual experience.
In accordance with informed consent, assessments will be obtained before treatment, at posttreatment, 3 and 6 months after the treatment conclusion.
- Conditions
- Obesity, Morbid Obesity
- Being tested
- Experiential-Cognitive Therapy for Obesity, Behavioral cognitive Treatment, Nutritional groups (NT)
- Keywords
- obesity treatment, evidence based intervention, cognitive behavioral treatment, virtual reality environments
- Medical subject headings
- Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experiential-Cognitive Therapy for ObesityBehavioural
Also called Virtual Reality Enhanced Therapy for Obesity
Is a relatively short-term, integrated, patient oriented approach that focuses on individual discovery (Riva, Bacchetta, Baruffi, Rinaldi, \& Molinari, 1998, 1999; Riva et al., 2000). It shares with the cognitive-behavioral approach proposed by Cooper and colleagues the use of a combination of cognitive and behavioral procedures to help the patient identify and change the maintaining mechanisms (Cooper et al., 2003). However, it considers morbid obesity as a peculiar form of addiction. So, as in the cognitive-behavioral treatment of addictions (Carroll et al., 1994) the two main goals are the functional analysis of the maintaining mechanisms and the required skill training (relapse prevention).
Behavioral cognitive TreatmentBehavioural
Also called Behavioral cognitive therapy, Obesity cognitive behavioral approach
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.
Nutritional groups (NT)Dietary supplement
Also called Nutritional treatment
5 weekly nutritional treatment 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).
| Study group | Role | What they receive |
|---|---|---|
| ECT | Experimental | Experiential-Cognitive Therapy for Obesity Receives: Behavioral: Experiential-Cognitive Therapy for Obesity |
| BCT | Active comparator | Cognitive behavioral treatment program Receives: Behavioral: Behavioral cognitive Treatment |
| NT | Sham comparator | Nutritional groups In this condition (NT) the participants enter only 5 weekly nutritional groups held by dietitians. Receives: Dietary Supplement: Nutritional groups (NT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Inventory: State-Trait IDARE
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)
Measured: Change from Baseline in Anxiety Inventory: State-Trait IDARE at 6 weeks, Change from Baseline in Anxiety Inventory: State-Trait IDARE at 6 months
Body Image Questionnaire (BSQ)
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.
Measured: Change frome Baseline in Body Image Questionnaire (BSQ) at 6 weeks, Change frome Baseline in Body Image Questionnaire (BSQ) at 6 months
Weight
Weight loss after the treatment and after the follow-up phase
Measured: Changes in weight from de first week will be assessed up to 6 weeks, changes in weight at 6 months
Secondary outcomes (3)
BULIT Bulimia Test
Self-administered questionnaire of 36 items designed to assess bulimic symptomatology (Smith \& Thelen, 1984). The questions are related to body weight, binge mood and purgative behavior. Adapted to Mexican population (Alvarez \& Vazquez-Manzilla, 2000).
Measured: 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)
Questionnaire comprising 51 items that measure three factors: cognitive dietary restraint, ie the perception that food intake is limited constants in an effort to control the body weight, disinhibition and hunger. (Stunkard \& Messick, 1985).
Measured: 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
Questionnaire developed for this study, which will reflect the level of satisfaction with treatment, which will assess how useful it has been each of the components of the treatment program (educational component, relaxation training, exposure component of each virtual scenarios (for conditions with virtual reality exposure).
Measured: Opinion on exposure therapy at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Auxologico Italiano, Medica Sur Clinic & Foundation
- Responsible party
- Principal investigator, DRA. GEORGINA CARDENAS LOPEZ, Universidad Nacional Autonoma de Mexico
- Investigators
- Giuseppe Riva, PhD, Study chair, Università Cattolica di MilanoGonzalo Torres-Villalobos, MD, Study director, Medica Sur FoundationAndrea Gaggioli, PhD, Study director, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394393
- Sponsor's protocol ID
- SALUD-2010-1-140220
- Other IDs
- SALUD-2010-1-140220.PHASE1
- Acronym
- AVATOB
- Status last verified
- May 2012
- First submitted
- 27 Jun 2011
- Last updated
- 31 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Riva G, Bacchetta M, Cesa G, Conti S, Castelnuovo G, Mantovani F, Molinari E. Is severe obesity a form of addiction? Rationale, clinical approach, and controlled clinical trial. Cyberpsychol Behav. 2006 Aug;9(4):457-79. doi: 10.1089/cpb.2006.9.457.
PubMed 16901250Riva G, Bacchetta M, Baruffi M, Molinari E. Virtual reality-based multidimensional therapy for the treatment of body image disturbances in obesity: a controlled study. Cyberpsychol Behav. 2001 Aug;4(4):511-26. doi: 10.1089/109493101750527079.
PubMed 11708731Riva G. The key to unlocking the virtual body: virtual reality in the treatment of obesity and eating disorders. J Diabetes Sci Technol. 2011 Mar 1;5(2):283-92. doi: 10.1177/193229681100500213.
PubMed 21527095
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambientes Virtuales Como Auxiliares en el Tratamiento de la Obesidad
- ClinicalTrials.gov ID
- NCT01394393
- Acronym / sponsor ID
- AVATOB / SALUD-2010-1-140220
- Conditions
- Obesity, Morbid Obesity
- Keywords
- obesity treatment, evidence based intervention, cognitive behavioral treatment, virtual reality environments
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad Nacional Autonoma de MexicoUniversity, hospital or other
- Collaborators
- Istituto Auxologico Italiano, Medica Sur Clinic & Foundation
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 14 Jul 2011 (estimated)
- 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.
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.
- 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).
- 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.
- 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.
Detailed description
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.
- 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.
- 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).
The edited scene is then visualized and experienced using the NeuroVR Player. Through the VR experience, the patients practice both eating/emotional/relational management and general decision-making and problem-solving skills. By directly practicing these skills within the VR environment, the patient is helped in developing specific strategies for avoiding and/or coping with these.
9 sessions are used to assess and modify:
- the expectations and emotions related to food and weight: This is done both by integrating different cognitive-behavioral methods: Countering, Alternative Interpretation, Label Shifting, Deactivating the Illness Belief
- the strategies used to cope with difficult interpersonal and potential maintenance situations: This is done both by using the Temptation Exposure with Response Prevention (Riva, 1998c; D. G. Schlundt \& Johnson, 1990) - and by working on these three empowering dimensions (Menon, 1999): perceived control, perceived competence and goal internalization.
- the body experience of the subject. To do this the virtual environment integrates the therapeutic methods used by Butter \& Cash (1987) and Wooley \& Wooley (1985). In particular in VREDIM we used the virtual environment in the same way as guided imagery (Leuner, 1969) is used in the cognitive and visual/motorial approach.
Structure of the sessions
Each session of Virtual Reality is divided into four phases:
The psychologist's office is the first virtual experience. It represents the start and the end of each session, and it has the important function to outline boundaries of the session in virtual reality. It is a neutral and reassuring place which allows continuity in the phases of the individual session: face to face, virtual reality and face to face.
In the psychologist's office there are the following objects: a writing-desk with two comfortable chairs, a bookshelf and complements of furnishings that make the environment more comfortable and hospitable (pictures, carpets, lamps, green plants, etc.). The safe place is the virtual experience for the relaxation that is used at the end of each session and, if needed, during the session of virtual reality. It is an empty park in which the patient can relax and recover from any emotional experience.
Between the psychologist's office and the safe place the patient experiences one or more specific virtual experience.
In accordance with informed consent, assessments will be obtained before treatment, at posttreatment, 3 and 6 months after the treatment conclusion.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ECT | Experimental | Behavioral: Experiential-Cognitive Therapy for ObesityExperiential-Cognitive Therapy for Obesity |
| BCT | Active comparator | Behavioral: Behavioral cognitive TreatmentCognitive behavioral treatment program |
| NT | Sham comparator | Dietary Supplement: Nutritional groups (NT)Nutritional groups In this condition (NT) the participants enter only 5 weekly nutritional groups held by dietitians. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Experiential-Cognitive Therapy for ObesityAlso: Virtual Reality Enhanced Therapy for ObesityIs a relatively short-term, integrated, patient oriented approach that focuses on individual discovery (Riva, Bacchetta, Baruffi, Rinaldi, \& Molinari, 1998, 1999; Riva et al., 2000). It shares with the cognitive-behavioral approach proposed by Cooper and colleagues the use of a combination of cognitive and behavioral procedures to help the patient identify and change the maintaining mechanisms (Cooper et al., 2003). However, it considers morbid obesity as a peculiar form of addiction. So, as in the cognitive-behavioral treatment of addictions (Carroll et al., 1994) the two main goals are the functional analysis of the maintaining mechanisms and the required skill training (relapse prevention). | Behavioural | ECT |
| Behavioral cognitive TreatmentAlso: Behavioral cognitive therapy, Obesity cognitive behavioral approachTherapists 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. | Behavioural | BCT |
| Nutritional groups (NT)Also: Nutritional treatment5 weekly nutritional treatment 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). | Dietary supplement | NT |
Primary outcome
Anxiety Inventory: State-Trait IDARE
Time frame: 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)
Time frame: 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
Time frame: 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
3 secondary outcomes
BULIT Bulimia Test
Time frame: 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)
Time frame: 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
Time frame: Opinion on exposure therapy at 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2012.
- Background: PubMed 16901250Riva G, Bacchetta M, Cesa G, Conti S, Castelnuovo G, Mantovani F, Molinari E. Is severe obesity a form of addiction? Rationale, clinical approach, and controlled clinical trial. Cyberpsychol Behav. 2006 Aug;9(4):457-79. doi: 10.1089/cpb.2006.9.457.
- Background: PubMed 11708731Riva G, Bacchetta M, Baruffi M, Molinari E. Virtual reality-based multidimensional therapy for the treatment of body image disturbances in obesity: a controlled study. Cyberpsychol Behav. 2001 Aug;4(4):511-26. doi: 10.1089/109493101750527079.
- Background: PubMed 21527095Riva G. The key to unlocking the virtual body: virtual reality in the treatment of obesity and eating disorders. J Diabetes Sci Technol. 2011 Mar 1;5(2):283-92. doi: 10.1177/193229681100500213.
- A previous Italian controlled trial based on the same protocol (it also included eating disorders, not covered by the actual trial)Link provided by the sponsor.
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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.
Giuseppe Riva, PhD study chair
Università Cattolica di Milano
Gonzalo Torres-Villalobos, MD study director
Medica Sur Foundation
Andrea Gaggioli, PhD study director
Istituto Auxologico Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Experiential-Cognitive Therapy for Obesity, Behavioral cognitive Treatment and Nutritional groups (NT) in people with Obesity and Morbid Obesity, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.
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 3 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: status not confirmed, as of the sponsor's last update on 31 May 2012. 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 Mexico. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georgina Cardenas-Lopez, PhD ((55)56222292, cardenas.georgina@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Inventory: State-Trait IDARE (time frame: 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 study lists 3 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 NCT01394393, which also lists 3 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 31 May 2012.