Behavioral Activation for Depression Through Virtual Reality

Sponsor

Universitat Jaume I (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05138744

Collaborator

(none)

Enrollment

Arm

2.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Depression	Other: Behavioral activation using virtual reality	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single case design (multiple baselines)Single case design (multiple baselines)

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Behavioral Activation for Depression Through Virtual Reality

Anticipated Study Start Date :

Dec 5, 2021

Anticipated Primary Completion Date :

Jan 22, 2022

Anticipated Study Completion Date :

Feb 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Virtual reality treatment 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.	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

Arm

Intervention/Treatment

Experimental: Virtual reality treatment

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.

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

Outcome Measures

Primary Outcome Measures

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

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 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 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?"
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?"

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Universitat Jaume I

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitat Jaume I

ClinicalTrials.gov Identifier:

NCT05138744

Other Study ID Numbers:

EMA1

First Posted:

Dec 1, 2021

Last Update Posted:

Dec 1, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depression

Depressive Disorder

Study Results

No Results Posted as of Dec 1, 2021