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Clinical Trials/NCT05138744
NCT05138744
Unknown
Not Applicable

Behavioral Activation for Depression Through Virtual Reality

Universitat Jaume I0 sites8 target enrollmentDecember 5, 2021
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Universitat Jaume I
Enrollment
8
Primary Endpoint
Change in Behavioral activation
Last Updated
4 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
December 5, 2021
End Date
February 20, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Universitat Jaume I
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Change in Behavioral activation

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)

In a scale from 0 (not at all) to 6 (completely), "to what extent were you satisfied with what you did today?"

Secondary Outcomes

  • 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))
  • 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))
  • 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))
  • 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))
  • 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))

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