Copenhagen Research Center for Mental Health - CORE
Copenhagen, Hellerup, 2900, Denmark
NCT Number: NCT04661163
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Copenhagen, Hellerup, 2900, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Virtual Reality Avatar Therapy is a psychotherapeutic intervention targeting auditory hallucinations
Other names: Virtual Reality Avatar Therapy
Time frame: 12 weeks from inclusion
Level of auditory hallucinations measured with The Psychotic Symptoms Rating Scales (PSYRATS-AH) total score at cessation of treatment at 12-weeks (score on PSYRATS-AH: 0-44. A score of 0 is the minimum score and 44 is the maximum score i.e. a score of 44 is the worst possible outcome.
Time frame: 12 weeks from inclusion
PSYRATS-AH-Frequency.
Time frame: 12 weeks from inclusion
PSYRATS-AH-Distress
Time frame: 12 weeks from inclusion
Questionnaire: the Voices Acceptance and Action Scale (VAAS-Action)
Time frame: 12 weeks from inclusion
Questionnaire: Assertive Responding to Voices (Approve - Voices), The assertive subscale (5 items with scores from 0-10, minimum score on this subscale is 0, maximum score is 50 with higher scores being a better outcome)
Time frame: 12 weeks from inclusion
The personal and social performance scale (PSP); (Scores from 1-100, with a score of 100 being the best possible outcome).
Time frame: 12 weeks from inclusion
Questionnaire: Voice Power Differential Scale, total score (range 7-35 with 7 being the minimum score and 35 the maximum score. Higher scores indicates greater power differential in favour of the voice - i.e. a worse outcome)
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Other
The CHALLENGE-trial: the Effects of a Virtual Reality-assisted Exposure Therapy for Persistent Auditory Hallucinations Versus Supportive Counselling in People With Psychosis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01963676
Auditory Hallucinations, Hallucinations
Chapel Hill, North Carolina, United States
View Trial DetailsNCT02670291
Auditory Hallucinations, Hallucinations
Tübingen, Germany
View Trial DetailsNCT00870909
Auditory Hallucinations, Hallucinations
Bron, France
View Trial DetailsNCT01015001
Auditory Hallucinations, Hallucinations
Porto Alegre, Rio Grande do Sul, Brazil
View Trial Details