Face Your Fears: Cognitive Behavioural Virtual Reality Therapy for "Paranoia".

NCT04902066 | Completed DMC

• 1 other identifier: 0134-00066B and ID 148727
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a randomised, assessor-blinded parallel-groups superiority clinical trial fulfilling the CONSORT criteria for non-pharmacological treatment. A total of 256 patients will be allocated to either Cognitive Behavioural Virtual Reality Therapy plus treatment as usual, versus traditional CBT for psychosis plus treatment as usual. All participants will be assessed at baseline and 3- and 9 months 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

Paranoid Schizophrenia; Schizophrenia and Related Disorders; Schizophrenia Prodromal; Schizotypal Disorder; Paranoid Ideation; Paranoid Delusion; Ideas of Reference; Psychosis Paranoid; Psychotic Disorders; Psychotic Paranoia; Psychotic; Disorder, Delusional

Outcome Measures

Primary Outcomes (1)

• (GPTS) Green Paranoid Thought Scale Part B: Ideas of persecution.

  The primary outcome is level of ideas of persecution measured with Green Paranoid Thought Scale at cessation of treatment at 3-months. The Green Paranoid Thought Scale has displayed good reliability and validity in patients with psychosis, displaying paranoid, persecutory delusions, and has also been used in patients at-risk for psychosis showing subthreshold psychotic symptoms. Minimum total score: 32. Maximum total score: 160. Part A (Ideas of social reference) minimum score: 16 and maximum score: 80. Part B (ideas of persecution) minimum score 16 and maximum score: 80. Part B score = or \> 45 are assumed to be threshold for development of persecutory delusion. Higher score means worse outcome.

  3 months from inclusion

Secondary Outcomes (6)

• SIAS (Social Interaction Anxiety Scale)

  3 and 9 months from inclusion

• SBQ (Safety Behaviour Questionnaire)

  3 and 9 months from inclusion

• PSP (Personal and Social Performance Scale)

  3 and 9 months from inclusion

• CANTAB ERT (Emotion Recognition Task)

  3 and 9 months from inclusion

• (GPTS) Green Paranoid Thought Scale Part A: Ideas of social reference

  3 and 9 months from inclusion

Other Outcomes (18)

• CDSS (Calgary Depression Scale for Schizophrenia)

  3 and 9 months from inclusion

• BNSS (Brief Negative Symptom Scale)

  3 and 9 months from inclusion

• COGDIS (Cognitive disturbances scale)

  3 and 9 months from inclusion

Study Arms (2)

Cognitive Behavioural Virtual Reality Therapy (CBT-VR)

EXPERIMENTAL

The CBT-VR consists of traditional CBT with the augmentation of virtual reality exposure. The virtual reality exposure comprises four virtual social environments (a bus, café, street, and supermarket). These are daily social situations that generally elicit paranoid thinking in patients with a schizophrenia spectrum disorder. While virtually engaging in these distressing situations, the therapist will facilitate a CBT dialogue aimed at generating alternative (i.e. non-threatening) thinking, diminishing safety behaviours (e.g. social isolation), and building up new coping strategies. This is expected to alleviate distress, anxiety, and improve daily social functioning. Preliminary findings reveal this virtual reality program to be well-tolerated and highly effective in reducing paranoia and anxiety in psychosis. Patients will be offered 10 individual sessions.

Other: Cognitive Behavioural Virtual Reality Therapy.

Traditional Cognitive Behavioural Therapy

ACTIVE COMPARATOR

The treatment in the CBT group will follow the core principles of CBT used for psychotic disorders. The CBT treatment facilitates an individualised, problem-oriented approach, and uses key CBT techniques such as developing a problem and goal list, normalising psychotic-like experiences, evaluation of appraisals, and removing or diminishing safety behaviour. Patients will be offered 10 individual sessions.

Other: Traditional Cognitive Behavioural Therapy

Interventions

Cognitive Behavioural Virtual Reality Therapy. OTHER

Cognitive Behavioural Therapy augmented with Virtual Reality.

Cognitive Behavioural Virtual Reality Therapy (CBT-VR)

Traditional Cognitive Behavioural Therapy OTHER

Traditional Cognitive Behavioural Therapy for psychosis.

Traditional Cognitive Behavioural Therapy

Eligibility Criteria

• Age: 18 Years+
• 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)
• Green Paranoid Thought Scale total score ≥ 40

You may not qualify if:

• Rejecting informed consent
• A diagnosis of organic brain disease
• IQ of 70 or lower (known mental retardation as assessed by medical record)
• A command of spoken Danish or English inadequate for engaging in therapy
• Inability to tolerate the assessment process

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• Central Denmark Region: 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 (3)

• Jeppesen UN, Vernal DL, Due AS, Mariegaard LS, Pinkham AE, Austin SF, Vos M, Christensen MJ, Hansen NK, Smith LC, Hjorthoj C, Veling W, Nordentoft M, Glenthoj LB. Virtual reality-based versus standard cognitive behavioral therapy for paranoia in schizophrenia spectrum disorders: a randomized controlled trial. Nat Med. 2025 Oct;31(10):3425-3439. doi: 10.1038/s41591-025-03880-8. Epub 2025 Aug 13.

  PMID: 40804323 DERIVED

• Jeppesen UN, Due AS, Mariegaard L, Pinkham A, Vos M, Veling W, Nordentoft M, Glenthoj LB. Update to the study protocol Face Your Fears: Virtual reality-based cognitive behavioral therapy (VR-CBT) versus standard CBT for paranoid ideations in patients with schizophrenia spectrum disorders: a randomized clinical trial. Trials. 2023 Jan 23;24(1):52. doi: 10.1186/s13063-023-07069-7.

  PMID: 36691039 DERIVED

• Jeppesen UN, Due AS, Mariegaard L, Pinkham A, Vos M, Veling W, Nordentoft M, Glenthoj LB. Face Your Fears: Virtual reality-based cognitive behavioral therapy (VR-CBT) versus standard CBT for paranoid ideations in patients with schizophrenia spectrum disorders: a randomized clinical trial. Trials. 2022 Aug 15;23(1):658. doi: 10.1186/s13063-022-06614-0.

  PMID: 35971137 DERIVED

MeSH Terms

Conditions

Schizophrenia, Paranoid; Schizophrenia; Schizotypal Personality Disorder; Paranoid Disorders; Psychotic Disorders; Mental Disorders; Delusions

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Personality Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Independent assessors blinded to the treatment will evaluate outcome. Investigator\'s conduct assessment and/or supervise assessments and are masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: May 26, 2021
• Study Start: April 9, 2021
• Primary Completion: March 21, 2024
• Study Completion: August 10, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)