Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04661163 |
| Other study ID # |
CHALLENGE |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 16, 2020 |
| Est. completion date |
July 16, 2024 |
Study information
| Verified date |
August 2023 |
| Source |
Mental Health Services in the Capital Region, Denmark |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The study is a randomised, assessor-blinded parallel-groups superiority clinical trial,
allocating a total of 266 patients to either the experimental intervention or standard
intervention. The participants will be randomised to either 12-weeks of virtual reality
therapy or supportive counselling. All participants will be assessed at 12- and 24 weeks post
baseline. A stratified block-randomisation with concealed randomisation sequence will be
conducted. Independent assessors blinded to the treatment will evaluate outcome. Analysis of
outcome will be carried out with the intention to treat principles.
Description:
Auditory hallucinations are among the most frequent symptoms in psychotic disorders. While a
large group of patients with first episode psychosis achieve remission of psychotic symptoms
during first year after initial contact with mental health services, almost one third
continue having psychotic symptoms in spite of treatment with antipsychotic medication. Since
auditory hallucinations are a major cause of distress and suffering for these patients, there
is an essential need to test the effectives of targeted psychotherapeutic interventions in
alleviating auditory hallucinations Two previous trials have provided preliminary evidence of
the effectiveness of virtual reality therapy on auditory hallucinations, but no trial to date
has examined the effect of virtual reality assisted therapy in an adequately powered RCT. In
this large-scale randomized, clinical trial, patients in the experimental intervention will
be receiving 7 sessions of virtual reality assisted avatar therapy while patients in the
control group will receive 7 sessions of supportive contact with mental health care
professionals at their regular outpatient clinic.
If the virtual reality therapy is found to be beneficial in reducing the severity of
refractory auditory hallucinations, it will be a breakthrough in the current treatment of
psychotic disorders. A large group of patients with schizophrenia and related disorders in
Denmark and worldwide will be the target group of the therapy. If proven effective, the
treatment will be especially relevant for patients with treatment resistant schizophrenia,
but the treatment can also be used as an add on to antipsychotic medication for patients with
a better prognosis, such as patients with first episode psychosis. If the virtual reality
therapy is proven effective, it can be implemented in mental health services in Denmark and
internationally. A successful implementation could reduce the costs associated with treatment
of schizophrenia.
