Clinical Efficacy of a Virtual Reality Tool for the Treatment of Obesity (SOCRATES)

Vall d'Hebron University Hospital (HUVH)

Status: Unknown

Conditions: Obesity, Morbid

Treatments: Behavioral: Experimental Group 1: Body swapping VR intervention + psychoeducational video + Treatment As usual; Behavioral: Control Group: Psychoeducational video + Treatment As usual; Behavioral: Experimental Group 2: VR intervention without body swapping + psychoeducational video + Treatment As usual

Study type: Interventional

Funder types: Other

Identifiers

NCT05094557

951930 (Other Grant/Funding Number)

SOCRATES_RCT/2021

Details and patient eligibility

About

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

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 3 patient groups

Experimental Group 1

Experimental group

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.

Treatment:

Behavioral: Experimental Group 1: Body swapping VR intervention + psychoeducational video + Treatment As usual

Experimental Group 2

Experimental group

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.

Treatment:

Behavioral: Experimental Group 2: VR intervention without body swapping + psychoeducational video + Treatment As usual

Control Group

Active Comparator group

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.

Treatment:

Behavioral: Control Group: Psychoeducational video + Treatment As usual