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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05138744
Other study ID # EMA1
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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