Back to resultsClinical Efficacy of a Virtual Reality Tool for the Treatment of Obesity (SOCRATES)
Primary Purpose
Obesity, Morbid
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental Group 1: Body swapping VR intervention + psychoeducational video + Treatment As usual
Experimental Group 2: VR intervention without body swapping + psychoeducational video + Treatment As usual
Control Group: Psychoeducational video + Treatment As usual
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Morbid focused on measuring Virtual Reality, obesity, Motivational Interviewing, embodiment, psychological treatment
Eligibility Criteria
Inclusion Criteria:
- BMI ≥ 30 kg/m2 and ≤ 55 kg/m2.
- Receiving ambulatory treatment at the Vall d´Hebron University Hospital.
- No concurrent involvement in other treatment related to the obesity condition.
- Minimal digital skills and able to use a proper digital device (Smartphone, tablet, computer).
- Oral and written understanding of the Spanish language to complete the questionnaires and use the system.
- Acceptance to sign the informed consent to participate.
Exclusion Criteria:
- Body Mass Index > 45.
- Presence of an Eating Disorder during the last 2 years.
- Non-stabilised severe mental disorder that could interfere with the successful implementation of the research protocol (i.e. psychosis, depression with suicidal risk, alcohol or drug abuse, psychotic or manic symptoms).
- Auditory or visual complications that might affect the participant during exposure to the VR platform.
- Intellectual disability or any major illness seriously affecting cognitive performance (i.e. neurological disorders).
- Personal history of epilepsy.
Sites / Locations
- Vall d'Hebron University Hospital, Psychiatry Department; Vall d'Hebron Institute of ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Experimental Group 1
Experimental Group 2
Control Group
Arm Description
Participants from the Experimental Group 1 will engage in a self-conversation through embodied perspective taking (body swapping), according to which they will be embodied alternately in their own virtual representation and in their counsellor's virtual body. They will also continue receiving Treatment As usual plus a Psychoeducational video with useful information about how to engage with a healthier lifestyle.
Participants from the Experimental Group 2 will be embodied in their own body and will participate in a "pre-established discourse" provided by their virtual counsellor. Participants will also continue receiving Treatment As usual plus a Psychoeducational video with useful information about how to engage with a healthier lifestyle.
Participants from the Control Group will receive their Treatment As Usual plus a Psychoeducational video. Treatment as usual will consist of regular medical, nutritional and/or psychiatric follow-ups with the obesity specialists of the Vall d´ Hebron University Hospital and standard routine tests. These visits aim to provide practical recommendations about how to achieve a gradual weight loss and engage more with physical exercise.
Outcomes
Primary Outcome Measures
Readiness to change I
Readiness Rulers are Visual Analogue Scales ranging from 1 to 10 that assess "Importance", "Confidence" and "Readiness" to change. For the present study, these 3 variables will be measured in terms of a) achieving a healthy weight and b) exercising more, while the "Readiness" scale will be used as critical response primary variable.
Readiness to change II
As a complementary readiness to change measure, the Spanish version of the Stages of Change in Overweight and Obese People (S-Weight) and the Processes of Change in Overweight and Obese People (P-Weight) will be used. Regarding P-Weight, lower scores on this scale reflect no use of a given process of change and higher scores reflect the full use of that process. To make scores from the different subscales comparable, these scores are transformed on a scale ranging from 0 to 100.
Secondary Outcome Measures
Eating habits I
Three Factor Eating Questionnaire-R18 (TFEQ-R18). The questionnaire assesses three different aspects of eating behaviour: (a) cognitive restraint (CR); (b) uncontrolled eating (UE) and (c) emotional eating (EE). The questionnaire consists of 18 items using a 4-point response scale which ranges from 1 (definitely true) to 4 (definitely false) and items scores are summated into the 3 different subscales: CR, UE and EE. Lower scores show more disordered eating while higher scores show healthier eating behaviour.
Eating habits II
Lifestyle habits questionnaire. The questionnaire consists of 22 items, each one of which is rated using a 5-poing Likert scale ranging from 1 (Never) to 5 (always), with higher scores indicated better lifestyle habits.
Psychological well-being I
Hamilton Anxiety and Depression Scale (HADS). The questionnaire consists of 14 items, 7 for anxiety and 7 for depression, and is used to detect the presence and severity of anxiety and depression among people with physical illnesses. The HADS is scored on a 4-point Likert scale ranging from 0 to 3, with the total score ranging from 0 to 42. Higher scores indicate a greater level of distress.
Psychological well-being II
Body Shape Questionnaire (BSQ). The BSQ is a 10-item self-report instrument, derived from the original 34-item version developed by Cooper, Taylor, Cooper, & Fairbum (1987), which assesses concerns about body shape expressed by clinical and non-clinical samples. It is based on a 6-point Likert scale questions (Never, Rarely, Sometimes, Often, Very Often, and Always) with higher scores indicating higher body dissatisfaction.
Psychological well-being III
Body Image QoL Inventory (BIQLI-SP). The BIQLI is a 19-item instrument designed to quantify the impact of one's body image experiences on several relevant facets of his/her psychosocial functioning and wellbeing in everyday life. The instrument uses a 7-point bipolar scale ranging from -3 (very negative effect) to 0 (no impact) to +3 (very positive impact), with higher scores indicating better psychological well-being in everyday life.
Psychological well-being IV
Weight Bias Internalization Scale (WBIS-M). The WBIS-M is a self-report 11-item unidimensional scale that is considered one of the most frequently used instruments for assessing internalized weight stigma across different body weight categories, in both clinical and research settings. Each answer is rated using a 7-point Liker scale, ranging from 1 (Strongly disagree) to 7 (Strongly agree) with higher scores indicating higher internalized weight bias. Items 1 and 9 are reverse scored.
Body Mass Index
Body Mass Index (kg/m2)
Cognitive Reserve Questionnaire
The CRQ is a self-report questionnaire developed and validated in Spanish population, which evaluates the degree of Cognitive Reserve (CR) in healthy controls and in patients with early signs of Alzheimer disease. The CRQ is composed of 8 items that assess aspects generally related to cognitive reserve ranges from 0 to 25 and is divided into quartiles. In this way, a score equal to or less than 6 points (≤ Q1) would show a low CR, between 7 and 9 points (Q1-Q2) would correspond to a low-medium CR, while scores between 10 and 14 (Q2-Q3) would show medium-high CR. Finally, scores ≥ 15 points would be classified as high CR (Q4).
Full Information
NCT ID
NCT05094557
First Posted
September 27, 2021
Last Updated
April 29, 2022
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
European Commission
1. Study Identification
Unique Protocol Identification Number
NCT05094557
Brief Title
Clinical Efficacy of a Virtual Reality Tool for the Treatment of Obesity
Acronym
SOCRATES
Official Title
Clinical Efficacy of a Virtual Reality Tool for the Treatment of Obesity (SOCRATES)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
European Commission
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of the study, which is framed within European Union's H2020 project titled SOCRATES, is to assess the clinical efficacy of a Virtual Reality (VR) embodiment tool for treating obesity and to compare it to usual care, through a Randomized Controlled Trial
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
Keywords
Virtual Reality, obesity, Motivational Interviewing, embodiment, psychological treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group 1
Arm Type
Experimental
Arm Description
Participants from the Experimental Group 1 will engage in a self-conversation through embodied perspective taking (body swapping), according to which they will be embodied alternately in their own virtual representation and in their counsellor's virtual body. They will also continue receiving Treatment As usual plus a Psychoeducational video with useful information about how to engage with a healthier lifestyle.
Arm Title
Experimental Group 2
Arm Type
Experimental
Arm Description
Participants from the Experimental Group 2 will be embodied in their own body and will participate in a "pre-established discourse" provided by their virtual counsellor. Participants will also continue receiving Treatment As usual plus a Psychoeducational video with useful information about how to engage with a healthier lifestyle.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants from the Control Group will receive their Treatment As Usual plus a Psychoeducational video. Treatment as usual will consist of regular medical, nutritional and/or psychiatric follow-ups with the obesity specialists of the Vall d´ Hebron University Hospital and standard routine tests. These visits aim to provide practical recommendations about how to achieve a gradual weight loss and engage more with physical exercise.
Intervention Type
Behavioral
Intervention Name(s)
Experimental Group 1: Body swapping VR intervention + psychoeducational video + Treatment As usual
Other Intervention Name(s)
EG1
Intervention Description
The patient will be embodied in his/her own avatar and will maintain a conversation with a counsellor's avatar of his/her choice. Once the experiment starts, the patient, embodied in his/her own body, will start describing his/her problem in terms of subjective experiences of being obese in daily life. Then, he/she will be body swapped to the counsellor's body and try to respond to the problem just manifested by the patient. The crucial aspect here is that the patient, from the counsellor's viewpoint, will see a representation of his/her real body when looking at the patient's avatar speaking and moving. Therefore, the patient will have the opportunity to see himself/herself in first person (1PP) and second person (2PP) perspectives.
Intervention Type
Behavioral
Intervention Name(s)
Experimental Group 2: VR intervention without body swapping + psychoeducational video + Treatment As usual
Other Intervention Name(s)
EG2
Intervention Description
Participants from the Experimental Group 2 will be embodied in their own body and will participate in "pre-established discourse" provided by the chosen counsellor, who will ask about the perceived barriers for engagement with a healthier lifestyle and will give practical recommendations about how to achieve a healthier and happier life, in terms of healthy eating and physical activity. No body swapping will take place for this group. Participants will also continue receiving Treatment As usual plus a Psychoeducational video with useful information about how to engage with a healthier lifestyle.
Intervention Type
Behavioral
Intervention Name(s)
Control Group: Psychoeducational video + Treatment As usual
Other Intervention Name(s)
CG
Intervention Description
Participants from the Control Group will receive their Treatment As Usual plus a Psychoeducational video. Treatment as usual will consist of regular medical, nutritional and/or psychiatric follow-ups with the obesity specialists of the Vall d´ Hebron University Hospital and standard routine tests. These visits aim to provide practical recommendations about how to achieve a gradual weight loss and engage more with physical exercise.
Primary Outcome Measure Information:
Title
Readiness to change I
Description
Readiness Rulers are Visual Analogue Scales ranging from 1 to 10 that assess "Importance", "Confidence" and "Readiness" to change. For the present study, these 3 variables will be measured in terms of a) achieving a healthy weight and b) exercising more, while the "Readiness" scale will be used as critical response primary variable.
Time Frame
Baseline (week 0); Post-Experiment1 (week 3)- Baseline; Post-Experiment2 (week 4)- Baseline; Post-Experiment3 (week 5) - Baseline; Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
Title
Readiness to change II
Description
As a complementary readiness to change measure, the Spanish version of the Stages of Change in Overweight and Obese People (S-Weight) and the Processes of Change in Overweight and Obese People (P-Weight) will be used. Regarding P-Weight, lower scores on this scale reflect no use of a given process of change and higher scores reflect the full use of that process. To make scores from the different subscales comparable, these scores are transformed on a scale ranging from 0 to 100.
Time Frame
Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
Secondary Outcome Measure Information:
Title
Eating habits I
Description
Three Factor Eating Questionnaire-R18 (TFEQ-R18). The questionnaire assesses three different aspects of eating behaviour: (a) cognitive restraint (CR); (b) uncontrolled eating (UE) and (c) emotional eating (EE). The questionnaire consists of 18 items using a 4-point response scale which ranges from 1 (definitely true) to 4 (definitely false) and items scores are summated into the 3 different subscales: CR, UE and EE. Lower scores show more disordered eating while higher scores show healthier eating behaviour.
Time Frame
Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
Title
Eating habits II
Description
Lifestyle habits questionnaire. The questionnaire consists of 22 items, each one of which is rated using a 5-poing Likert scale ranging from 1 (Never) to 5 (always), with higher scores indicated better lifestyle habits.
Time Frame
Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
Title
Psychological well-being I
Description
Hamilton Anxiety and Depression Scale (HADS). The questionnaire consists of 14 items, 7 for anxiety and 7 for depression, and is used to detect the presence and severity of anxiety and depression among people with physical illnesses. The HADS is scored on a 4-point Likert scale ranging from 0 to 3, with the total score ranging from 0 to 42. Higher scores indicate a greater level of distress.
Time Frame
Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
Title
Psychological well-being II
Description
Body Shape Questionnaire (BSQ). The BSQ is a 10-item self-report instrument, derived from the original 34-item version developed by Cooper, Taylor, Cooper, & Fairbum (1987), which assesses concerns about body shape expressed by clinical and non-clinical samples. It is based on a 6-point Likert scale questions (Never, Rarely, Sometimes, Often, Very Often, and Always) with higher scores indicating higher body dissatisfaction.
Time Frame
Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
Title
Psychological well-being III
Description
Body Image QoL Inventory (BIQLI-SP). The BIQLI is a 19-item instrument designed to quantify the impact of one's body image experiences on several relevant facets of his/her psychosocial functioning and wellbeing in everyday life. The instrument uses a 7-point bipolar scale ranging from -3 (very negative effect) to 0 (no impact) to +3 (very positive impact), with higher scores indicating better psychological well-being in everyday life.
Time Frame
Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
Title
Psychological well-being IV
Description
Weight Bias Internalization Scale (WBIS-M). The WBIS-M is a self-report 11-item unidimensional scale that is considered one of the most frequently used instruments for assessing internalized weight stigma across different body weight categories, in both clinical and research settings. Each answer is rated using a 7-point Liker scale, ranging from 1 (Strongly disagree) to 7 (Strongly agree) with higher scores indicating higher internalized weight bias. Items 1 and 9 are reverse scored.
Time Frame
Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
Title
Body Mass Index
Description
Body Mass Index (kg/m2)
Time Frame
Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
Title
Cognitive Reserve Questionnaire
Description
The CRQ is a self-report questionnaire developed and validated in Spanish population, which evaluates the degree of Cognitive Reserve (CR) in healthy controls and in patients with early signs of Alzheimer disease. The CRQ is composed of 8 items that assess aspects generally related to cognitive reserve ranges from 0 to 25 and is divided into quartiles. In this way, a score equal to or less than 6 points (≤ Q1) would show a low CR, between 7 and 9 points (Q1-Q2) would correspond to a low-medium CR, while scores between 10 and 14 (Q2-Q3) would show medium-high CR. Finally, scores ≥ 15 points would be classified as high CR (Q4).
Time Frame
Baseline (week 0)
Other Pre-specified Outcome Measures:
Title
Adherence and satisfaction with the VR platform I
Description
Suitability Evaluation Questionnaire (SEQ). The SEQ is a 14-item questionnaire designed to measure satisfaction, acceptance and security of use in VR systems and it was specifically designed for rehabilitation systems using VR. Thirteen questions of the SEQ are based on a 6-point Likert scale plus a last open-ended question offering participants the possibility to add comments, if necessary. The global score of SEQ ranges from 13 (poor suitability) to 65 (excellent suitability).
Time Frame
Post-Experiment1 (week 3); Post-Experiment2 (week 4)- Post-Experiment1; Post-Experiment3 (week 5)- Post-Experiment1; Post-Intervention (week 6)- Post-Experiment1
Title
Adherence and satisfaction with the VR platform II
Description
Body Ownership questionnaire does a subjective rating of the illusion of body ownership during the virtual experience through 4 questions that use a 7-point Likert scale, where -3 means "not at all" and +3 "very much" (1. body ownership when looking down; 2. body ownership when looking at the mirror; 3. body ownership when moving; 4. self recognition).
Time Frame
Post-Experiment1 (week 3); Post-Experiment2 (week 4)- Post-Experiment1; Post-Experiment3 (week 5)- Post-Experiment1; Post-Intervention (week 6)- Post-Experiment1
Title
Adherence and satisfaction with the VR platform III
Description
User experiment and feedback (qualitative / interview)
Time Frame
Post-Experiment1 (week 3); Post-Experiment2 (week 4); Post-Experiment3 (week 5); Post-Intervention (week 6)
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI ≥ 30 kg/m2 and ≤ 55 kg/m2.
Receiving ambulatory treatment at the Vall d´Hebron University Hospital.
No concurrent involvement in other treatment related to the obesity condition.
Minimal digital skills and able to use a proper digital device (Smartphone, tablet, computer).
Oral and written understanding of the Spanish language to complete the questionnaires and use the system.
Acceptance to sign the informed consent to participate.
Exclusion Criteria:
Body Mass Index > 45.
Presence of an Eating Disorder during the last 2 years.
Non-stabilised severe mental disorder that could interfere with the successful implementation of the research protocol (i.e. psychosis, depression with suicidal risk, alcohol or drug abuse, psychotic or manic symptoms).
Auditory or visual complications that might affect the participant during exposure to the VR platform.
Intellectual disability or any major illness seriously affecting cognitive performance (i.e. neurological disorders).
Personal history of epilepsy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dimitra Anastasiadou, PhD
Phone
+34 677871092
Email
dimitra.anastasiadou@vhir.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pilar Lusilla-Palacios, MD, PhD
Organizational Affiliation
Vall d'Hebron University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vall d'Hebron University Hospital, Psychiatry Department; Vall d'Hebron Institute of Research
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dimitra Anastasiadou, PhD
Phone
+34677871092
Email
dimitra.anastasiadou@vhir.org
First Name & Middle Initial & Last Name & Degree
Dimitra Anastasiadou, PhD
First Name & Middle Initial & Last Name & Degree
Pilar Lusilla-Palacios, MD, PhD
First Name & Middle Initial & Last Name & Degree
Julia Vazquez De Sebastian, MSc
First Name & Middle Initial & Last Name & Degree
Gemma Parramon-Puig, MD, PhD
First Name & Middle Initial & Last Name & Degree
Josep Antoni Ramos-Quiroga, MD, PhD
First Name & Middle Initial & Last Name & Degree
Andreea Ciudin, MD, PHD
First Name & Middle Initial & Last Name & Degree
Marta Comas, MSc
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data that support the findings of this study will be available on request from the corresponding author once the study is published. The data are not publicly available due to the sensitivity of participants´data.
Citations:
PubMed Identifier
35732390
Citation
Anastasiadou D, Slater M, Spanlang B, Cano Porras D, Comas M, Ciudin A, Puig GP, Vazquez-De Sebastian J, Ramos-Quiroga JA, Lusilla-Palacios P. Clinical efficacy of a virtual reality tool for the treatment of obesity: study protocol of a randomised controlled trial. BMJ Open. 2022 Jun 22;12(6):e060822. doi: 10.1136/bmjopen-2022-060822.
Results Reference
derived
Learn more about this trial
Clinical Efficacy of a Virtual Reality Tool for the Treatment of Obesity
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