Behavioral Activation for Depression Through Virtual Reality

Evaluate the effectiveness of a brief, virtual reality intervention for depressed mood

Study Overview

• Status: Not yet recruiting
• Conditions: Depression
• Intervention / Treatment: Other: Behavioral activation using virtual reality

• Study Type: Interventional
• Enrollment (Anticipated): 8
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Desirée Colombo, PhD; Phone Number: 964 387648; Email: dcolombo@uji.es
• Study Contact Backup: Name: Carlos Suso, PhD; Email: susor@uji.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient Health Questionnaire - 9 (measure of depression) over 9
• Positive and Negative Affect Schedule (measure of positive and negative affect): positive affect score below 24
• Age over 18 years
• Signs informed consent

Exclusion Criteria:

• Completes more than 20% of evaluations retrospectively (not the day they are assigned)
• Has a severe mental health disorder as evaluated with the MINI International Neuropsychiatric Interview
• Does not sign the informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual reality treatment; Use of google maps with virtual reality to virtually situate the participants into scenarios that are motivating for them (i.e., the beach, a mountain, a park, etc.) at their choice.	Other: Behavioral activation using virtual reality; The investigators will encourage behavioral activation (increase in the number and time of conducted activities) situating the person in motivating situations using virtual reality

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Behavioral activation	In a scale from 0 (not at all) to 6 (completely), "to what extent were you satisfied with what you did today?"	Change through study completion, an average of 31 days. The outcome will be evaluated daily (at 9pm) during 31 days. Changes will be investigated from baseline to posttreatment using all corresponding time points (baseline vs posttreatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mood	In a scale from 0 (completely sad) to 100 (completely happy), "how did you feel today?"	Change through study completion, an average of 31 days. The outcome will be evaluated daily (at 9pm) during 31 days. Changes will be investigated from baseline to posttreatment using all corresponding time points (baseline to posttreatment)
Change in Depression	In a scale from 0 (not at all) to 3 (completely), "how was your level of depression today?"	Change through study completion, an average of 31 days.. The outcome will be evaluated daily (at 9pm) during 31 days. Changes will be investigated from baseline to posttreatment using all corresponding time points (baseline to posttreatment)
Change in Positive affect	In a scale from 1 (not at all) to 5 (completely), "how was your positive affect today?"	Change through study completion, an average of 31 days.. The outcome will be evaluated daily (at 9pm) during 31 days. Changes will be investigated from baseline to posttreatment using all corresponding time points (baseline to posttreatment)
Change in Negative affect	In a scale from 1 (not at all) to 5 (completely), "how was your negative affect today?"	Change through study completion, an average of 31 days.. The outcome will be evaluated daily (at 9pm) during 31 days. Changes will be investigated from baseline to posttreatment using all corresponding time points (baseline to posttreatment)
Change in Activity level	In a scale from 0 (minimum) to 100 (maximum), "what was your activity level today?"	Change through study completion, an average of 31 days.. The outcome will be evaluated daily (at 9pm) during 31 days. Changes will be investigated from baseline to posttreatment using all corresponding time points (baseline to posttreatment)

Collaborators and Investigators

• Sponsor: Universitat Jaume I

Study record dates

Study Major Dates

• Study Start (Anticipated): December 5, 2021
• Primary Completion (Anticipated): January 22, 2022
• Study Completion (Anticipated): February 20, 2022

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: November 30, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: EMA1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be anonymized and will only be shared upon reasonable request without identifying information

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No