Major Depressive DisorderVR-MoodboostNCT05486676
VR-Moodboost; an Innovative Virtual Reality Treatment for Adolescents With Depression
A study testing VR-Moodboost; a Virtual Reality intervention for depression to enhance positive affect and reduce depressive symptoms. in people with Major Depressive Disorder, run by Claudi Bockting at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 23 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- VR-Moodboost; a Virtual Reality intervention for depression to enhance positive affect and reduce depressive symptoms.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Jul 2022to 2 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VR-Moodboost in the Treatment of Depression; a Proof-of-concept Study
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.
Read the detailed description
Adolescents with a depressive disorder who might be eligible for participation will be asked for permission to be contacted by a researcher by their treating psychologist or treating physician either face-to-face, by telephone or by e-mail. Researchers will inform the potential participants about the study by means of a patient information letter and the possibility to ask additional questions by telephone or in a face to face appointment with the researcher. The participant must sign informed consent before participation. The potential participant will be given one week to consider their decision to participate in the study.
The population consists of 10 participants. As indicated by the framework 'effectladder' which is used by the Netherlands Youth Institute to determine which interventions are evidence-based, a sample size of N=10 is sufficient to demonstrate evidence if the effect of treatment is replicated in the majority of cases. By using daily diary data in the baseline and treatment phase of the study, we will be able to compare change in symptoms in baseline phase with change in symptoms in treatment phase.
The VR-Moodboost treatment consists of 12 sessions, and in these sessions the Virtual Reality software Social Worlds VR-CBT will be used. Social Worlds VR-CBT has a medical certificate, and has many different treatment possibilities. In this study, the investigators make use of a specific part of the software; a Virtual Reality environment in which participants can perform activities of choice and get rewarded for the activities they did at home. The first session of the VR-Moodboost treatment will start with psychoeducation about depression and about the rationale of the treatment and the main aim; to increase positive affect. Every next session, the patient will perform different virtual activities of choice, for more information about the activities see 'VR environment'. Because the main aim of the VR-Moodboost treatment is to increase positive affect, patients will be supported and encouraged to (learn to) experience positive affect. For example, the patients will be encouraged to label his/her emotions during the activity in VR, and during the discussion of the homework. In addition, cognitive challenge techniques will be used to stimulate patients to pay attention to positive aspects of a situation (for example, mention 3 positive things or aspects in the VR environment). At the end of each session, the therapist encourages the participant to convert the virtual activity practiced during session into a real-life activity, which would evoke the same positive feeling as the virtual activity and will be practiced at home. The patient will be stimulated to visualize this activity as a goal for the upcoming week. Then the next session, after reflecting on the activity the patient did at home, the participant gets a reward in de VR environment. In general, every session has the following structure; reflect on the activity which the patient did in real life, reveal a virtual reward, perform different virtual activities of choice, explore and visualize an activity for the following week. The sixth session includes an evaluation, and the last session includes a relapse prevention plan.
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 as recommended by What Works Clearinghouse (WWC). During the baseline period the patient will make a personal alert plan with their treating psychologist. After baseline (A-phase), a trained therapist performs the 12 session VR-Moodboost (B-phase). The investigators will measure the primary and secondary outcomes at start baseline, start intervention, post intervention after a 1-month and 6-month follow-up period. The acceptability of the session will be measured after every session of therapy. During the A- and B-phase, up until two months after treatment, patients will keep track of their daily mood, activities and self-efficacy using a patient diary by means of a smartphone app. After all 10 participants have conducted the B-phase, a focus group will be organized for both the patients and therapists who have participated to obtain feedback about the VR-Moodboost intervention.
The main study parameters are positive and negative affect and daily positive and negative mood. In this proof-of-concept study results will be analyzed at the individual case level in two ways: using questionnaires at 4 time points and using daily diary data. The investigators will calculate the Reliable Change Index to assess statistical significance of differences in questionnaire scores between time points. The Reliable Change Index is calculated as follows: (posttest- pretest)/ SEM, where SEM = SDinstrument * √(1- reliability). Daily diary data will be analyzed using multilevel analysis using Shiny app MultiSCED. At the individual level the investigators assess whether the intercept and slope on positive and negative mood in the baseline phase significantly differs from the intercept and slope in the treatment phase. Results will be aggregated across participants using the meta-analysis method. State of the art of imputation of missings will be used.
The handling of the personal data is according to the Dutch Act on Implementation of the General Data Protection Regulation (in Dutch: Uitvoeringswet AVG, UAVG). The investigators will separate he data files from the name and date of birth files. The name and date of birth file will be locked with a password; this file contains a code for each participant. The code is a three-digit patient number (YYY). The data files will be collected in the online database Castor. The coordinating investigators safeguard the key to the code. Data will be kept for 15 years according to the aforementioned act.
The Amsterdam UMC Clinical Monitoring Center (CMC) will monitor this study according to the guidelines of the Dutch Federation of University Medical Centres (NFU: Nederlandse Federatie van Universitaire Medische Centra). The CMC-CRA prepared a monitoring plan based on the study protocol in agreement with the coordinating investigator.
All adverse events reported spontaneously by the subject or observed by the investigator or his staff will be recorded. The investigator will report all SAEs to the sponsor without undue delay after obtaining knowledge of the events. The sponsor will report the SAEs through the web portal ToetsingOnline to the accredited METC that approved the protocol, within 7 days of first knowledge for SAEs that result in death or are life threatening followed by a period of maximum of 8 days to complete the initial preliminary report. All other SAEs will be reported within a period of maximum 15 days after the sponsor has first knowledge of the serious adverse events.
- Conditions
- Major Depressive Disorder
- Being tested
- VR-Moodboost; a Virtual Reality intervention for depression to enhance positive affect and reduce depressive symptoms.
- Keywords
- Major Depressive Disorder, Virtual Reality, Positive affect, Depressive symptoms, Adolescents
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-Moodboost; a Virtual Reality intervention for depression to enhance positive affect and reduce depressive symptoms.Behavioural
All participants receive the same VR-Moodboost treatment, they only differ in the length of the baseline; 3 or 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| VR-Moodboost | Experimental | All participants receive the same VR-Moodboost treatment, they only differ in the length of the baseline; 3 or 5 weeks. Receives: Behavioral: VR-Moodboost; a Virtual Reality intervention for depression to enhance positive affect and reduce depressive symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From baseline to two months post-treatment (23-25 weeks)
Secondary outcomes (11)
BDI-II - Beck Depression Inventory
Depressive symptoms as measured by the Beck Depression Inventory (BDI-II). The score range is 0 to 63. Higher scores mean more severe depression symptoms.
Measured: 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)
Activation (daily estimation of number of minutes active) as measured with the daily smartphone diary. This metric is assessed through a smartphone diary.
Measured: From baseline to two months post-treatment (23-25 weeks)
Self-efficacy (Smartphone Diary)
Single item about self-efficacy "Right now, I believe I can succeed my current goals, if I set my mind to it", scored on a 7-point Likert scale. This item is assessed using a smartphone diary.
Measured: From baseline to two months post-treatment (23-25 weeks)
KIDSSCREEN / WHOQOL-BREF - Quality of life
Quality of life as measured by the KIDSSCREEN (age 15-17) and the WHOQOL-BREF (age 18-23). Both at the WHOQOL-BREF and the KIDSSCREEN, higher scores mean better quality of life. Score range of the KIDSSCREEN is 27-135. For the WHOQOL-BREF, There is no overall score, each domain is calculated by summation of their specific items. Maximum scores are: Overall quality of life and General health; 20; Physical health; 35, Psychological health 30, Social relationships 15, and Environment; 40.
Measured: 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)
A general sense of perceived self-efficacy as measured with the General Self-Efficacy Scale (GSES).De score range is 10 to 40. Higher scores mean better self-efficacy.
Measured: 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).
SRS - Session Rating Scale
Acceptability as measured by the Session Rating Scale (SRS). The score range is 0-40. Higher scores mean better acceptability.
Measured: From week 3 or 5 to week 15 or 17 (weekly at every VR-session)
IPQ - I-Group Presence Questionnaire
Presence in VR as measured by the I-group presence questionnaire (IPQ). Score range is 0-6. A higher score indicating a greater experienced presence in VR.
Measured: At week 15 or 17
SUS - System Usability Scale
Usability as measured by the System Usability Scale (SUS). SUS scores range from 0 to 100, higher scores mean better SUS.
Measured: At week 3 or 5 and week 15 or 17
Involvement in VR
Line of sight of participants in VR (extent to which the line of sight deviates from a fixed anchor point) to assess active involvement. This metric is assessed during the 12 VR-Moodboost sessions.
Measured: From week 3 or 5 to week 15 or 17 (weekly at every VR-session)
Semi-structured Interview
Semi-structured interview for both patient and therapist about their experience with the VR-Moodboost. This metric is assessed at the end of the intervention phase.
Measured: At week 15 or 17 (end of VR-Moodboost therapy)
Focus Group
Feedback from focus group with participating patients and therapists about their experience, acceptability and usability of the VR-moodboost. This metric is assessed at the end of the intervention phase.
Measured: At the end of study, estimated 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start25 Jul 2022
- Primary completion2 Mar 2026
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claudi Bockting
- Sponsor type
- University, hospital or other
- Collaborators
- GGZ Delfland
- Responsible party
- Sponsor-investigator, Claudi Bockting, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Claudi LH Bockting, PhD, Principal investigator, Department of Psychiatry, University of Amsterdam, Amsterdam University Medical Centers, Amsterdam, The Netherlands; Centre for Urban Mental Health, University of Amsterdam, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486676
- Sponsor's protocol ID
- NL77018.018.21
- Acronym
- VR-Moodboost
- Status last verified
- Apr 2026
- First submitted
- 25 Jul 2022
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VR-Moodboost in the Treatment of Depression; a Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT05486676
- Acronym / sponsor ID
- VR-Moodboost / NL77018.018.21
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Virtual Reality, Positive affect, Depressive symptoms, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Claudi BocktingUniversity, hospital or other
- Collaborators
- GGZ Delfland
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Adolescents with a depressive disorder who might be eligible for participation will be asked for permission to be contacted by a researcher by their treating psychologist or treating physician either face-to-face, by telephone or by e-mail. Researchers will inform the potential participants about the study by means of a patient information letter and the possibility to ask additional questions by telephone or in a face to face appointment with the researcher. The participant must sign informed consent before participation. The potential participant will be given one week to consider their decision to participate in the study.
The population consists of 10 participants. As indicated by the framework 'effectladder' which is used by the Netherlands Youth Institute to determine which interventions are evidence-based, a sample size of N=10 is sufficient to demonstrate evidence if the effect of treatment is replicated in the majority of cases. By using daily diary data in the baseline and treatment phase of the study, we will be able to compare change in symptoms in baseline phase with change in symptoms in treatment phase.
The VR-Moodboost treatment consists of 12 sessions, and in these sessions the Virtual Reality software Social Worlds VR-CBT will be used. Social Worlds VR-CBT has a medical certificate, and has many different treatment possibilities. In this study, the investigators make use of a specific part of the software; a Virtual Reality environment in which participants can perform activities of choice and get rewarded for the activities they did at home. The first session of the VR-Moodboost treatment will start with psychoeducation about depression and about the rationale of the treatment and the main aim; to increase positive affect. Every next session, the patient will perform different virtual activities of choice, for more information about the activities see 'VR environment'. Because the main aim of the VR-Moodboost treatment is to increase positive affect, patients will be supported and encouraged to (learn to) experience positive affect. For example, the patients will be encouraged to label his/her emotions during the activity in VR, and during the discussion of the homework. In addition, cognitive challenge techniques will be used to stimulate patients to pay attention to positive aspects of a situation (for example, mention 3 positive things or aspects in the VR environment). At the end of each session, the therapist encourages the participant to convert the virtual activity practiced during session into a real-life activity, which would evoke the same positive feeling as the virtual activity and will be practiced at home. The patient will be stimulated to visualize this activity as a goal for the upcoming week. Then the next session, after reflecting on the activity the patient did at home, the participant gets a reward in de VR environment. In general, every session has the following structure; reflect on the activity which the patient did in real life, reveal a virtual reward, perform different virtual activities of choice, explore and visualize an activity for the following week. The sixth session includes an evaluation, and the last session includes a relapse prevention plan.
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 as recommended by What Works Clearinghouse (WWC). During the baseline period the patient will make a personal alert plan with their treating psychologist. After baseline (A-phase), a trained therapist performs the 12 session VR-Moodboost (B-phase). The investigators will measure the primary and secondary outcomes at start baseline, start intervention, post intervention after a 1-month and 6-month follow-up period. The acceptability of the session will be measured after every session of therapy. During the A- and B-phase, up until two months after treatment, patients will keep track of their daily mood, activities and self-efficacy using a patient diary by means of a smartphone app. After all 10 participants have conducted the B-phase, a focus group will be organized for both the patients and therapists who have participated to obtain feedback about the VR-Moodboost intervention.
The main study parameters are positive and negative affect and daily positive and negative mood. In this proof-of-concept study results will be analyzed at the individual case level in two ways: using questionnaires at 4 time points and using daily diary data. The investigators will calculate the Reliable Change Index to assess statistical significance of differences in questionnaire scores between time points. The Reliable Change Index is calculated as follows: (posttest- pretest)/ SEM, where SEM = SDinstrument * √(1- reliability). Daily diary data will be analyzed using multilevel analysis using Shiny app MultiSCED. At the individual level the investigators assess whether the intercept and slope on positive and negative mood in the baseline phase significantly differs from the intercept and slope in the treatment phase. Results will be aggregated across participants using the meta-analysis method. State of the art of imputation of missings will be used.
The handling of the personal data is according to the Dutch Act on Implementation of the General Data Protection Regulation (in Dutch: Uitvoeringswet AVG, UAVG). The investigators will separate he data files from the name and date of birth files. The name and date of birth file will be locked with a password; this file contains a code for each participant. The code is a three-digit patient number (YYY). The data files will be collected in the online database Castor. The coordinating investigators safeguard the key to the code. Data will be kept for 15 years according to the aforementioned act.
The Amsterdam UMC Clinical Monitoring Center (CMC) will monitor this study according to the guidelines of the Dutch Federation of University Medical Centres (NFU: Nederlandse Federatie van Universitaire Medische Centra). The CMC-CRA prepared a monitoring plan based on the study protocol in agreement with the coordinating investigator.
All adverse events reported spontaneously by the subject or observed by the investigator or his staff will be recorded. The investigator will report all SAEs to the sponsor without undue delay after obtaining knowledge of the events. The sponsor will report the SAEs through the web portal ToetsingOnline to the accredited METC that approved the protocol, within 7 days of first knowledge for SAEs that result in death or are life threatening followed by a period of maximum of 8 days to complete the initial preliminary report. All other SAEs will be reported within a period of maximum 15 days after the sponsor has first knowledge of the serious adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| VR-Moodboost | Experimental | Behavioral: VR-Moodboost; a Virtual Reality intervention for depression to enhance positive affect and reduce depressive symptoms.All participants receive the same VR-Moodboost treatment, they only differ in the length of the baseline; 3 or 5 weeks. |
Who may qualify
- Ages
- 15 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR-Moodboost; a Virtual Reality intervention for depression to enhance positive affect and reduce depressive symptoms.All participants receive the same VR-Moodboost treatment, they only differ in the length of the baseline; 3 or 5 weeks. | Behavioural | VR-Moodboost |
Primary outcome
Change in positive and negative affect, as measured by the Positive and Negative Affect Schedule (PANAS).
Time frame: 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).
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.
Change in Positive and Negative Affect (Smartphone Diary)
Time frame: From baseline to two months post-treatment (23-25 weeks)
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.
11 secondary outcomes
BDI-II - Beck Depression Inventory
Time frame: 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)
Time frame: From baseline to two months post-treatment (23-25 weeks)
Self-efficacy (Smartphone Diary)
Time frame: From baseline to two months post-treatment (23-25 weeks)
KIDSSCREEN / WHOQOL-BREF - Quality of life
Time frame: 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)
Time frame: 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).
SRS - Session Rating Scale
Time frame: From week 3 or 5 to week 15 or 17 (weekly at every VR-session)
IPQ - I-Group Presence Questionnaire
Time frame: At week 15 or 17
SUS - System Usability Scale
Time frame: At week 3 or 5 and week 15 or 17
Involvement in VR
Time frame: From week 3 or 5 to week 15 or 17 (weekly at every VR-session)
Semi-structured Interview
Time frame: At week 15 or 17 (end of VR-Moodboost therapy)
Focus Group
Time frame: At the end of study, estimated 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudi LH Bockting, PhD principal investigator
Department of Psychiatry, University of Amsterdam, Amsterdam University Medical Centers, Amsterdam, The Netherlands; Centre for Urban Mental Health, University of Amsterdam, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-Moodboost; a Virtual Reality intervention for depression to enhance positive affect and reduce depressive symptoms. in people with Major Depressive Disorder, run by Claudi Bockting at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in positive and negative affect, as measured by the Positive and Negative Affect Schedule (PANAS). (time frame: 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.