VR-Moodboost; an Innovative Virtual Reality Treatment for Adolescents With Depression

NCT05486676 | Completed DMC

• 1 other identifier: NL77018.018.21
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Major depressive disorder (MDD) is a prevalent and disabling mental health condition. A recent meta-analysis shows that across all forms of psychotherapy, only 43% of all depressive patients fully recover from MDD and relapse rates are high. Therefore, there is a strong need for innovative interventions with better treatment outcomes. Most traditional psychotherapies for depression focus on reducing negative affect. However, in patients suffering from depression, anhedonia, or loss of positive affect, is associated with poor prognosis and increased chance of suicide. Recent studies show promising results for novel psychotherapies with a focus on enhancing positive affect. Experimental studies indicate that non-verbal stimuli have a stronger impact on activation of positive affect than verbal stimuli, which makes Virtual reality (VR) a promising tool to enhance positive affect. For the current study the investigators developed an innovative VR treatment protocol to enhance positive affect and reduce depressive symptoms in patients with MDD. This study will include 10 adolescents aged 15 to 23 years old, who have a diagnosis of unipolar mild to severe depression. A trained psychologist will perform the VR-Moodboost intervention in twelve weekly sessions. The overall aim of this explorative proof-of-concept study is to provide first evidence that treatment with VR-Moodboost will lead to symptom improvement in adolescents with depression. The investigators hypothesize that VR-Moodboost will lead to an increase in positive affect, daily positive mood and a decrease in negative affect and daily negative mood in adolescents with mild to severe depression. Secondary, the investigators hypothesize that the VR-moodboost will lead to a decrease of depressive symptoms, an increase in daily activation, an increase in quality of life and an increase of self-efficacy for the participating patients. Moreover, the investigators hypothesize that VR-Moodboost leads to high patient acceptability and high usability for both patient and therapist.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Virtual Reality; Positive affect; Depressive symptoms; Adolescents

Outcome Measures

Primary Outcomes (2)

• Change in positive and negative affect, as measured by the Positive and Negative Affect Schedule (PANAS).

  Scores can range from 10-50 for both Positive affect and Negative affect with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect.

  There are two different baseline periods; 3 or 5 weeks. This metric is assessed at week 0 (start baseline), at week 3 or 5 (start VR-Moodboost therapy), at week 15 or 17 (study completion), one month and six months posttreatment (follow-up).

• Change in Positive and Negative Affect (Smartphone Diary)

  Daily positive and negative affected as measured by 3 items for negative and 3 items for positive mood. Items were based on previous daily diary studies. This metric is assessed through a smartphone diary, from start baseline, during treatment, until two months after the VR-Moodboost therapy.

  From baseline to two months post-treatment (23-25 weeks)

Secondary Outcomes (11)

• BDI-II - Beck Depression Inventory

  This metric is assessed at week 0 (start baseline), at week 3 or 5 (start VR-Moodboost therapy), at week 15 or 17 (study completion), one month and six months posttreatment (follow-up).

• Activation (Smartphone Diary)

  From baseline to two months post-treatment (23-25 weeks)

• Self-efficacy (Smartphone Diary)

  From baseline to two months post-treatment (23-25 weeks)

• KIDSSCREEN / WHOQOL-BREF - Quality of life

  This metric is assessed at week 0 (start baseline), at week 3 or 5 (start VR-Moodboost therapy), at week 15 or 17 (study completion), one month and six months posttreatment (follow-up).

• The General Self-Efficacy Scale (GSES)

  This metric is assessed at week 0 (start baseline), at week 3 or 5 (start VR-Moodboost therapy), at week 15 or 17 (study completion), one month and six months posttreatment (follow-up).

Other Outcomes (1)

• Demographics & Other

  During screening

Study Arms (1)

VR-Moodboost

EXPERIMENTAL

All participants receive the same VR-Moodboost treatment, they only differ in the length of the baseline; 3 or 5 weeks.

Behavioral: VR-Moodboost; a Virtual Reality intervention for depression to enhance positive affect and reduce depressive symptoms.

Interventions

VR-Moodboost; a Virtual Reality intervention for depression to enhance positive affect and reduce depressive symptoms. BEHAVIORAL

All participants receive the same VR-Moodboost treatment, they only differ in the length of the baseline; 3 or 5 weeks.

VR-Moodboost

Eligibility Criteria

• Age: 15 Years - 23 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• A principal diagnosis of mild-severe depression, either a first or a recurrent episode, as determined by a BIG-registered psychologist (clinical or GZ) or psychiatrist. The severity of the current depressive episode will be determined following the guidelines of the SCID-5 and the SCID-5 Junior.
• Age between 15-23.
• Written informed consent by the patient (age 16-23) or by the patients AND a caregiver (age 15) to participate in the study.

You may not qualify if:

• Intellectual disability in the history.
• A principal diagnosis of depression with psychotic features.
• Current high suicidality risk (suicidality plans).
• Severe comorbid psychiatric disorders including schizophrenia-like disorders, bipolar disorder or addictive disorders in the past six months.
• Current use of antidepressants, antipsychotics or sedatives.
• Uncorrected hearing- or vision problems

Sponsors & Collaborators

• Claudi Bockting: lead
• GGZ Delfland: collaborator

Study Sites (1)

GGZ Delfland

Delft, South Holland, 2612GA, Netherlands

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Claudi LH Bockting, PhD

  Department of Psychiatry, University of Amsterdam, Amsterdam University Medical Centers, Amsterdam, The Netherlands; Centre for Urban Mental Health, University of Amsterdam, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Clinical Psychology in Psychiatry

Model Details: The study has a non-concurrent, multiple baseline, single-case, AB-design. Participants will first be randomly allocated to a 3 or 5-week baseline period. After baseline (A-phase), a trained therapist performs the 12 session VR-Moodboost (B-phase), followed by a follow-up phase.

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: August 3, 2022
• Study Start: July 25, 2022
• Primary Completion: March 2, 2026
• Study Completion: March 2, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

NL (1)