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 patients with depression. Primary objective:We hypothesize that VR-Moodboost will lead to an…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Positive and negative affect
Secondary outcome
- Depressive symptoms
- Activation
- Quality of life
- Self-efficacy
- Acceptability
- Usability
- Active involvement in VR
- Presence in VR
Background summary
Depression is the most common and expensive mental disorder amongst adolescents
in The Netherlands and has a tremendous daily life impact. Despite effective
treatments, only 50% of all depressive patients fully recover or experience a
clinically meaningful reduction in symptoms. Recent research shows that
available treatments are even less effective in adolescents compared to adults.
Novel, more effective treatments are necessary to help adolescents recover from
their depression, in order to prevent chronicity and improve quality of life
and return to daily activities.
Positive and negative affect dynamics play an important role in depression.
Positive affect is the ability to experience and express positive feelings and
emotions including cheerfulness, pride and enthusiasm. The same counts for
negative feelings and emotions in negative affect, like sadness, distress and
disgust. Most traditional treatments for depression focus on reduction of
negative affect. However, positive affect dynamics are also disturbed in
depression. Anhedonia or loss of pleasure in depression is associated with poor
prognosis, increased chance of suicide and future depression symptoms.
Moreover, the majority of patients with depression see the recovery of positive
mood as the main treatment goal. Especially adolescents indicate the importance
of being able to experience positive emotions, life satisfaction and personal
growth. Positive affect could therefore be a potentially powerful target for
treatment.
Neurobiological research shows that a lack of positive affect is related to a
less active reward system. In addition, neurobiological research in adolescents
at high risk for depression shows reduced reward response compared to
adolescents without depression, especially during reward anticipation. Previous
approaches focused on increasing positive affect in individuals with depression
show promising results. Also, as experimental studies indicate that non-verbal
stimuli have a stronger impact on activation of positive affect than verbal
stimuli, the power of targeting positive affect may even be stronger when also
including non-verbal elements.
Based on these recent scientific insights, in a unique collaboration of GGZ
Delfland and AMC Psychiatry, we created a novel and innovative intervention
called Virtual Reality-Moodboost (VR-Moodboost). The aim of VR-Moodboost is to
increase positive affect in 12 sessions by combining elements of reward
processing, positive goalsetting and affect labeling, using direct exposure to
visual stimuli through Virtual Reality. In a proof of concept study, we aim to
provide the first evidence that this novel intervention is effective in
treating depression.
Study objective
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
patients with depression.
Primary objective:
We hypothesize that VR-Moodboost will lead to an increase in positive affect
and a decrease in negative affect.
Secondary objectives:
In addition, we hypothesize that the VR-depression will lead to a reduction in
depressive symptoms, an increase in activity level, quality of life and
self-efficacy, high patient acceptability and high usability for both patient
and therapist. We want to use the feedback provided by both patients and
therapists in the set-up of a large RCT comparing VR-Moodboost to CBT.
Study design
We will conduct a multiple case study with an A-B design. Since this is a
proof-of-concept study, we will include 10 outpatients with a mild-severe
depression. Participants will first engage in a baseline (A-phase) condition
for 3 or 5 weeks (which will be randomized), during which no treatment takes
place. This baseline period is similar to the regular waitlist until treatment.
Patients will make a signalling plan in this period with their therapist. After
this baseline period, a trained psychologist performs the 12 session
VR-Moodboost (B-phase). Subsequently, there will be a phase without active
intervention (C-phase). We will measure the primary and secondary outcomes at
start baseline, start intervention, post intervention after a 1-month and
6-month follow-up period (C-phase). During the A- and B-phase up to and
including two months after the B-phase, patients will keep track of their mood
using a patient diary by means of a smartphone app.
Intervention
The VR-Moodboost environment is designed to activate positive affect, using
visual and auditory stimuli. In the VR environment, the participant enters an
art gallery and gets to choose an activity out of four categories. The
categories include solo-, group- inside- and outside activities. Each category
is represented by a painting in the gallery. Within every category the
participant can choose out of multiple activities, such as watching a sunset,
playing a game or taking photographs in a city park. These include both 360
degrees and animated VR activities. To strengthen the experience of the
positive affect induced by the activity, the participant is encouraged to label
his emotions during the activity, after which the therapist will add a textual
label which can be seen in the virtual activity.
When the participant has finished the activity the emotional/textual label will
be presented in the main gallery as a virtual reward. At the end of each
session the therapist encourages the participant to convey his virtual activity
in a real-life activity, which would evoke the same positive feeling as the
virtual activity, which he can perform in the upcoming week. Each next session
starts with discussing the real-life activity of the previous week, and
labeling the emotion the participant felt during the real-life activity. Then
the participant chooses another virtual reward (art object), which is added to
the gallery. Therefore, performing both a virtual and a real-life activity
will result in a reward in the virtual gallery. At the end of the therapy, the
participant will receive an actual reward in the form of a small poster
containing all the labels he attributed to the performed virtual and real-life
activities; a *reward tree*.
Study burden and risks
We expect participating patients are expected to benefit from the VR-moodboost
treatment. We expect an improvement of depressive symptoms, a decrease of
negative affect and an increase of positive affect, quality of life and
self-efficacy. Worsening of symptoms is not expected to happen. Since we are
studying a new treatment method in a proof-of-concept study, there is a minor
risk the participants will not benefit from the VR-moodboost treatment.
However, we consider the theoretical rationale of VR-moodboost as strong and
former studies have shown beneficial effects of psychotherapies focussing on
positive affect and behavioural activation. If this proof-of-concept study
shows a positive effect of the VR-moodboost treatment, it provides an essential
step towards adding a novel psychotherapy technique to the treatment of
depression for adolescents, which would be of enormous value. The 3-5 weeks
baseline phase and the 12 sessions of treatment are comparable to regular
psychotherapy for depression (CBT). Participants can withdrawal from the
treatment or from the study at any time and this has no effect on their care as
usual.
There are no known risks associated with the VR-moodboost environment. Some
participants might experience some nausea (e.g. cybersickness) whilst wearing
the Head Mounted Display (HMD). The experience of patients so far is that this
usually disappears quickly after removing the HMD.
Also, the VR moodboost environment is designed with 90 PFS (frames per second),
to prevent cybersickness. During the activity the participant will be standing
mostly in one spot, this also reduces the risk of nausea. Therefore the risks
of participation can be considered negligible minor and the burden minimal.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- A principal diagnosis of mild to severe depression, either a first or
recurrent episode, as determined by a BIG-registered psychologist (clinical or
GZ) or psychiatrist.
- Age between 15 to 23.
- Written informed consent by the patient to participate in the study if they
are over 18 years old or written informed consent by the patient*s
parent/caregiver if they are under 18 years old.
Exclusion criteria
- Intellectual disability in the patient's 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 antipsychotics or sedatives.
- Current trajectory of adjusting or switching antidepressants (a stable dose
of antidepressants at time of inclusion is allowed)
- Abnormal hearing and/or uncorrected vision.
Design
Recruitment
Medical products/devices used
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
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In other registers
Register | ID |
---|---|
CCMO | NL77018.018.21 |