Ignite Creation Date:
2024-05-05 @ 11:43 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01394393
Status:
UNKNOWN
Last Update Posted:
2012-05-31
First Post:
2011-06-27
Brief Title:
Virtual Environments For Supporting Obesity Treatment
Sponsor:
Universidad Nacional Autonoma de Mexico
Organization:
Universidad Nacional Autonoma de Mexico
Study Overview
Official Title:
Ambientes Virtuales Como Auxiliares en el Tratamiento de la Obesidad
Status:
UNKNOWN
Status Verified Date:
2012-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AVATOB
Brief 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
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 N20 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 N20 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 eg stressing gradual weight loss with the caloric restriction achieved largely by reductions in fat intake plus a low-calorie diet 1200 kcalday and physical training 30 min of walking two times a week as a minimum
2 Cognitive-Behavioral therapy CBT group N20 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 eg 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 N4 involved the same treatment proposed in the first condition plus 15 additional sessions over 46 weeks
In the sessions we will use the 202020 rule During the first 20 minutes the therapist focus on getting a clear understanding of the patients 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 patients 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 andor coping with it In the final 20 minutes the therapist explores the patients 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
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 N20 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 N20 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 eg stressing gradual weight loss with the caloric restriction achieved largely by reductions in fat intake plus a low-calorie diet 1200 kcalday and physical training 30 min of walking two times a week as a minimum
2 Cognitive-Behavioral therapy CBT group N20 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 eg 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 N4 involved the same treatment proposed in the first condition plus 15 additional sessions over 46 weeks
In the sessions we will use the 202020 rule During the first 20 minutes the therapist focus on getting a clear understanding of the patients 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 patients 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 andor coping with it In the final 20 minutes the therapist explores the patients 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
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 eg stressing gradual weight loss with the caloric restriction achieved largely by reductions in fat intake plus a low-calorie diet 1200 kcalday 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 eg 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 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 15 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 maintainingrelapse mechanisms Home Supermarket Pub Restaurant Swimming Pool Beach Gymnasium and two body image comparison areas
Using the NeuroVR Editor the psychological stimulistressors 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 channelThe 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 eatingemotionalrelational 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 andor 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 visualmotorial approach
Structure of the sessions
Each session of Virtual Reality is divided into four phases
The psychologists 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 psychologists 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 psychologists 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
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 eg stressing gradual weight loss with the caloric restriction achieved largely by reductions in fat intake plus a low-calorie diet 1200 kcalday 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 eg 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 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 15 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 maintainingrelapse mechanisms Home Supermarket Pub Restaurant Swimming Pool Beach Gymnasium and two body image comparison areas
Using the NeuroVR Editor the psychological stimulistressors 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 channelThe 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 eatingemotionalrelational 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 andor 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 visualmotorial approach
Structure of the sessions
Each session of Virtual Reality is divided into four phases
The psychologists 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 psychologists 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 psychologists 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SALUD-2010-1-140220PHASE1 | OTHER | UNIVERSIDAD NACIONAL AUTONOMA DE MEXICO | None |