CHALLENGE. A Randomised Clinical Trial Examining Virtual Reality Therapy

NCT04661163 | Completed DMC

• 1 other identifier: CHALLENGE
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Auditory Hallucinations

Keywords

Avatar; Schizophrenia; Auditory Hallucinations; Psychotherapy; Virtual Reality; Psychosis; Virtual Reality Therapy

Outcome Measures

Primary Outcomes (1)

• Level of auditory hallucinations

  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.

  12 weeks from inclusion

Secondary Outcomes (6)

• Frequency of auditory hallucinations

  12 weeks from inclusion

• Distress caused by auditory hallucinations

  12 weeks from inclusion

• Voice acceptance

  12 weeks from inclusion

• Assertive Responding to Voices

  12 weeks from inclusion

• Personal and social performance

  12 weeks from inclusion

Study Arms (2)

Virtual reality avatar therapy

EXPERIMENTAL

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

Supportive counselling (comparison group)

NO INTERVENTION

The control group is offered seven session with health professionals providing supportive counselling. This can (but does not necessarily) involve psychotherapy targeting auditory hallucinations.

Interventions

Psychotherapy OTHER

Virtual Reality Avatar Therapy is a psychotherapeutic intervention targeting auditory hallucinations

Also known as: Virtual Reality Avatar Therapy

Virtual reality avatar therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• Region of Southern Denmark: collaborator
• Mental Health Services in the North Denmark Region: collaborator

Study Sites (1)

Copenhagen Research Center for Mental Health - CORE

Copenhagen, Hellerup, 2900, Denmark

Location

Related Publications (1)

• Smith LC, Vernal DL, Mariegaard LS, Christensen AG, Jansen JE, Schytte G, Stokbro LA, Albert N, Christensen MJ, Thomas N, Hjorthoj C, Nordentoft M, Glenthoj LB. Immersive virtual reality-assisted therapy targeting persistent auditory verbal hallucinations in patients diagnosed with schizophrenia spectrum disorders in Denmark: the Challenge assessor-masked, randomised clinical trial. Lancet Psychiatry. 2025 Aug;12(8):557-567. doi: 10.1016/S2215-0366(25)00161-0. Epub 2025 Jul 3.

  PMID: 40617245 DERIVED

MeSH Terms

Conditions

Hallucinations; Schizophrenia; Psychotic Disorders

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Merete Nordentoft, professor

  Mental Health Services Capitol of Denmark; Copenhagen Research Center for Mental Health - CORE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent assessors blinded to the treatment will evaluate outcome.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomised, assessor-blinded parallel-groups superiority clinical trial

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 10, 2020
• Study Start: November 16, 2020
• Primary Completion: February 27, 2024
• Study Completion: April 2, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)