Behavioral Activation for Depression Through Virtual Reality

Depression Clinical Trial

Official title:

Behavioral Activation for Depression Through Virtual Reality

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05138744
• Other study ID #: EMA1
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 5, 2021
• Est. completion date: February 20, 2022

Study information

• Verified date: November 2021
• Source: Universitat Jaume I
• Contact: Desirée Colombo, PhD
• Phone: 964 387648
• Email: dcolombo[@]uji.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8
• Est. completion date: February 20, 2022
• Est. primary completion date: January 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitat Jaume I

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)