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CHALLENGE. A Randomised Clinical Trial Examining Virtual Reality Therapy

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ClinicalTrials.gov Identifier: NCT04661163
Recruitment Status : Recruiting
First Posted : December 10, 2020
Last Update Posted : March 3, 2022
Sponsor:
Collaborators:
Mental Health Services in the Region of Southern Denmark
Mental Health Services in the North Denmark Region
Information provided by (Responsible Party):
Mental Health Services in the Capital Region, Denmark

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Auditory Hallucinations Other: Psychotherapy Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomised, assessor-blinded parallel-groups superiority clinical trial
Masking: Single (Outcomes Assessor)
Masking Description: Independent assessors blinded to the treatment will evaluate outcome.
Primary Purpose: Treatment
Official Title: The CHALLENGE-trial: the Effects of a Virtual Reality-assisted Exposure Therapy for Persistent Auditory Hallucinations Versus Supportive Counselling in People With Psychosis
Actual Study Start Date : November 16, 2020
Estimated Primary Completion Date : February 16, 2023
Estimated Study Completion Date : August 16, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Virtual reality avatar therapy
Patients will be offered seven individual sessions of virtual reality therapy and two booster sessions conducted by a skilled therapist. In the initial phase of treatment, the participants create a virtual avatar that corresponds to their visual perception of the source of their voice. The therapist initiates, encourages and supports a dialogue between the participant and the avatar by alternating between talking as the avatar and as a supportive therapist. The therapy sessions last 50 minutes of which around 15 minutes is spent in dialogue with the avatar. The remaining 30 minutes will be used on preparing the patient for the confrontation with the avatar, evaluating on the interaction with the avatar, and use general cognitive behavioral techniques to reduce the auditory hallucination. The treatment is conducted with the use of virtual reality, so the participant will wear VR headset during treatment and watch and talk with the avatar shown in front of him or her.
 Other: Psychotherapy
Virtual Reality Avatar Therapy is a psychotherapeutic intervention targeting auditory hallucinations
Other Name: Virtual Reality Avatar Therapy
No Intervention: Supportive counselling (comparison group)
The control group is offered seven session with health professionals providing supportive counselling. This can (but does not necessarily) involve psychotherapy targeting auditory hallucinations.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)

  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 - years
  2. Ability to give informed consent
  3. A schizophrenia spectrum disorder (ICD-10 code: F20 -F29)
  4. Auditory hallucinations for at least three months, corresponding to a SAPS score on auditory hallucinations of ≥3.

  5. No changes in antipsychotic medication within the past four weeks and

    1. Not responding to current antipsychotic compound or
    2. Not responding to at least two antipsychotic compounds. Table2

Exclusion Criteria:

  1. Rejecting informed consent
  2. Unable to identify a single dominant voice to work on
  3. A diagnosis of organic brain disease
  4. Substance to a level that hinders engagement in therapy.
  5. Auditory hallucinations in a language not spoken by the therapists
  6. A command of spoken Danish or English inadequate for engaging in therapy
  7. Inability to tolerate the assessment process
  8. Strongly impaired vision
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04661163


Contacts
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Contact: Lisa C Smith 21575107 ext +45 lisa.smith@regionh.dk
Contact: Louise B Glenthøj, Ph.D Louise.Birkedal.Glenthoej@regionh.dk

Locations
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Denmark
Copenhagen Research Center for Mental Health - CORE Recruiting
Copenhagen, Hellerup, Denmark, 2900
Contact: Lisa C Smith    21575107 ext +45    lisa.smith@regionh.dk   
Sponsors and Collaborators
Mental Health Services in the Capital Region, Denmark
Mental Health Services in the Region of Southern Denmark
Mental Health Services in the North Denmark Region
Investigators
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Principal Investigator: Merete Nordentoft, professor Mental Health Services Capitol of Denmark; Copenhagen Research Center for Mental Health - CORE
More Information
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Responsible Party: Mental Health Services in the Capital Region, Denmark
ClinicalTrials.gov Identifier: NCT04661163    
Other Study ID Numbers: CHALLENGE
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: March 3, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mental Health Services in the Capital Region, Denmark:
Avatar
Schizophrenia
Auditory Hallucinations
Psychotherapy
 Virtual Reality
Psychosis
Virtual Reality Therapy
Additional relevant MeSH terms:
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Hallucinations
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases