Back to resultsBehavioral Activation for Depression Through Virtual Reality
Primary Purpose
Depression
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Behavioral activation using virtual reality
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Virtual reality treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
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?"
Secondary Outcome Measures
Change in Mood
In a scale from 0 (completely sad) to 100 (completely happy), "how did you feel today?"
Change in Depression
In a scale from 0 (not at all) to 3 (completely), "how was your level of depression today?"
Change in Positive affect
In a scale from 1 (not at all) to 5 (completely), "how was your positive affect today?"
Change in Negative affect
In a scale from 1 (not at all) to 5 (completely), "how was your negative affect today?"
Change in Activity level
In a scale from 0 (minimum) to 100 (maximum), "what was your activity level today?"
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05138744
Brief Title
Behavioral Activation for Depression Through Virtual Reality
Official Title
Behavioral Activation for Depression Through Virtual Reality
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 5, 2021 (Anticipated)
Primary Completion Date
January 22, 2022 (Anticipated)
Study Completion Date
February 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitat Jaume I
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
Evaluate the effectiveness of a brief, virtual reality intervention for depressed mood
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single case design (multiple baselines)
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual reality treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Behavioral activation using virtual reality
Intervention Description
The investigators will encourage behavioral activation (increase in the number and time of conducted activities) situating the person in motivating situations using virtual reality
Primary Outcome Measure Information:
Title
Change in Behavioral activation
Description
In a scale from 0 (not at all) to 6 (completely), "to what extent were you satisfied with what you did today?"
Time Frame
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 Measure Information:
Title
Change in Mood
Description
In a scale from 0 (completely sad) to 100 (completely happy), "how did you feel today?"
Time Frame
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)
Title
Change in Depression
Description
In a scale from 0 (not at all) to 3 (completely), "how was your level of depression today?"
Time Frame
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)
Title
Change in Positive affect
Description
In a scale from 1 (not at all) to 5 (completely), "how was your positive affect today?"
Time Frame
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)
Title
Change in Negative affect
Description
In a scale from 1 (not at all) to 5 (completely), "how was your negative affect today?"
Time Frame
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)
Title
Change in Activity level
Description
In a scale from 0 (minimum) to 100 (maximum), "what was your activity level today?"
Time Frame
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Desirée Colombo, PhD
Phone
964 387648
Email
dcolombo@uji.es
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Suso, PhD
Email
susor@uji.es
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be anonymized and will only be shared upon reasonable request without identifying information
Learn more about this trial
Behavioral Activation for Depression Through Virtual Reality
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