Behavioral Activation for Depression Through Virtual Reality

NCT05138744 | Unknown

• 1 other identifier: EMA1
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 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 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)

• 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)

Study Arms (1)

Virtual reality treatment

EXPERIMENTAL

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

Interventions

Behavioral activation using virtual reality OTHER

The investigators will encourage behavioral activation (increase in the number and time of conducted activities) situating the person in motivating situations using virtual reality

Virtual reality treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat Jaume I: lead

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Desirée Colombo, PhD

CONTACT

964 387648; dcolombo@uji.es

Carlos Suso, PhD

CONTACT

susor@uji.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single case design (multiple baselines)

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: December 1, 2021
• Study Start: December 5, 2021
• Primary Completion: January 22, 2022
• Study Completion: February 20, 2022
• Last Updated: December 1, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share