Behavioral Activation for Depression Through Virtual Reality

Not Applicable

• Conditions: Depression
• Interventions: Other: Behavioral activation using virtual reality

• Registration Number: NCT05138744
• Lead Sponsor: Universitat Jaume I

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-26
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-30
• Last Update Submitted: 2021-11-30
• Study First Posted: 2021-12-01
• Last Update Posted: 2021-12-01
• Study Start: 2021-12-05
• Primary Completion: 2022-01-22
• Study Completion: 2022-02-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual reality treatment	Behavioral activation using virtual reality	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.

Primary Outcome Measures

Name	Time	Method
Change in Behavioral activation	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)	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

Name	Time	Method
Change in Activity level	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)	In a scale from 0 (minimum) to 100 (maximum), "what was your activity level today?"
Change in Depression	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)	In a scale from 0 (not at all) to 3 (completely), "how was your level of depression today?"
Change in Mood	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)	In a scale from 0 (completely sad) to 100 (completely happy), "how did you feel today?"
Change in Positive affect	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)	In a scale from 1 (not at all) to 5 (completely), "how was your positive affect today?"
Change in Negative affect	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)	In a scale from 1 (not at all) to 5 (completely), "how was your negative affect today?"