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Completed

NCT Number: NCT04661163

CHALLENGE. A Randomised Clinical Trial Examining Virtual Reality Therapy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen Research Center for Mental Health - CORE

Copenhagen, Hellerup, 2900, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 - years
  • Ability to give informed consent
  • A schizophrenia spectrum disorder (ICD-10 code: F20 -F29)
  • Auditory hallucinations for at least three months, corresponding to a SAPS score on auditory hallucinations of ≥3.
  • No changes in antipsychotic medication within the past four weeks and
  • Not responding to current antipsychotic compound or
  • Not responding to at least two antipsychotic compounds. Table2

Exclusion criteria

  • Rejecting informed consent
  • Unable to identify a single dominant voice to work on
  • A diagnosis of organic brain disease
  • Substance to a level that hinders engagement in therapy.
  • Auditory hallucinations in a language not spoken by the therapists
  • A command of spoken Danish or English inadequate for engaging in therapy
  • Inability to tolerate the assessment process
  • Strongly impaired vision

Treatment and study plan

Psychotherapy

Other

Virtual Reality Avatar Therapy is a psychotherapeutic intervention targeting auditory hallucinations

Other names: Virtual Reality Avatar Therapy

Primary outcomes

  1. Level of auditory hallucinations

    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.

Secondary outcomes

  1. Frequency of auditory hallucinations

    Time frame: 12 weeks from inclusion

    PSYRATS-AH-Frequency.

  2. Distress caused by auditory hallucinations

    Time frame: 12 weeks from inclusion

    PSYRATS-AH-Distress

  3. Voice acceptance

    Time frame: 12 weeks from inclusion

    Questionnaire: the Voices Acceptance and Action Scale (VAAS-Action)

  4. Assertive Responding to Voices

    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)

  5. Personal and social performance

    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).

  6. Perceived voice power

    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)

Sponsors and collaborators

Lead sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Other

Collaborators

  • Mental Health Services in the North Denmark Region
  • Region of Southern Denmark

Registry information

Official study title

The CHALLENGE-trial: the Effects of a Virtual Reality-assisted Exposure Therapy for Persistent Auditory Hallucinations Versus Supportive Counselling in People With Psychosis

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Dec 10, 2020
Registry last updated
Nov 25, 2024

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.

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