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

Primary Purpose

Paranoid Schizophrenia, Schizophrenia and Related Disorders, Schizophrenia Prodromal

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cognitive Behavioural Virtual Reality Therapy.
Traditional Cognitive Behavioural Therapy
Sponsored by
Mental Health Services in the Capital Region, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paranoid Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18 - years
  2. Ability to give informed consent
  3. A schizophrenia spectrum disorder (ICD-10 code: F20 -F29)
  4. Green Paranoid Thought Scale total score ≥ 40

Exclusion Criteria:

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

Sites / Locations

  • Copenhagen Research Center for Mental Health - CORERecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Behavioural Virtual Reality Therapy (CBT-VR)

Traditional Cognitive Behavioural Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

(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.

Secondary Outcome Measures

SIAS (Social Interaction Anxiety Scale)
Minimum score: 0 Maximum score: 20*4=80. Item 5,9 and 11 have reverse score. Higher score means worse outcome.
SBQ (Safety Behaviour Questionnaire)
Minimum score: 0. Maximum score is in theory unlimited depending on the number of identified, specific safety behaviours.
PSP (Personal and Social Performance Scale)
Minimum score: 1 Maximum score: 100. Higher score means better outcome.
CANTAB ERT (Emotion Recognition Task)
(GPTS) Green Paranoid Thought Scale Part A: Ideas of social reference
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 delusion. Higher score means worse outcome.
(GPTS) Green Paranoid Thought Scale Part B: Ideas of persecution
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 delusion. Higher score means worse outcome.

Full Information

First Posted
April 19, 2021
Last Updated
November 14, 2022
Sponsor
Mental Health Services in the Capital Region, Denmark
Collaborators
Central Denmark Region, Mental Health Services in the North Denmark Region
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1. Study Identification

Unique Protocol Identification Number
NCT04902066
Brief Title
Face Your Fears: Cognitive Behavioural Virtual Reality Therapy for "Paranoia".
Acronym
FYF
Official Title
Face Your Fears: An Assessor-blinded, RCT Evaluating the Effectiveness of Cognitive Behavioural Virtual Reality Therapy Versus Cognitive Behavioural Therapy in Patients With Schizophrenia Spectrum Disorders.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 9, 2021 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mental Health Services in the Capital Region, Denmark
Collaborators
Central Denmark Region, Mental Health Services in the North Denmark Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Ideas of reference and ideas of persecution are among the most frequent symptoms in psychotic disorders, and they hinder patients in conducting daily activities such as leaving the home or using public transportation - as well as inflicting immensely on their quality of life. The social avoidance caused by these symptoms does not improve with antipsychotic mediation. Cognitive behavioural therapy (CBT) for psychosis has demonstrated beneficial effect on psychotic symptoms, but the average effect sizes are in the small to moderate range, and training and resource requirements mean that, in practice, therapy is not delivered to all those who might benefit. Hence, there is considerable interest in the development of novel therapies that draw on the principles of cognitive behavioural therapy for psychosis, but which are shorter, more effective, and are capable of being delivered by a wider workforce. Augmenting CBT with virtual reality exposure has the possibility of creating artificial experiences in real time, that make the user feel immersed and able to interact as if it was the real world. Additionally, virtual reality therapy allows for personalization of the therapy to match the specific social challenges of each patient. Preliminary findings suggest virtual reality exposure to lead to faster symptom reduction than traditional therapy. While the potential beneficial effects of virtual reality exposure to psychotic, and sub-threshold psychotic symptoms, such as ideas of reference and ideas of persecution, are evident and virtual reality therapies are promising in general, the research field is in an urgent need of evidence on the effectiveness of virtual reality therapy in patients with schizophrenia spectrum disorders. The proposed trial is hitherto the largest trial in the world to evaluate the effectiveness of cognitive behavioural virtual reality therapy (CBT-VR) compared to traditional CBT. The investigators expect to find CBT-VR to be more beneficial in reducing ideas of reference and ideas of persecution in patients with schizophrenia spectrum disorders. Additionally, the investigators expect it to result in improved depressive, anxiety-, and negative symptoms, as well as improved social cognition and psychosocial functioning and quality of life in patients with schizophrenia spectrum disorders. The target group in the trial also encompass patients with schizotypal disorder (often young adults), showing subthreshold psychotic symptoms (e.g. ideas of reference), that are at increased risk of developing manifest psychosis. The CBT-VR may show efficacy in preventing progression to an overt psychotic state in these patients. Hence, there is a great potential for CBT-VR in the treatment of patients with psychosis and sub-threshold psychosis, but studies are needed to establish evidence for the treatment. If the results of the current trial are positive, the manualised treatment can easily be implemented in clinical practise. Note: When the trial was initiated, the original primary outcome was ideas of persecution, measured with part B in Green Paranoid Thought Scale (GPTS) while ideas of social reference, measured with part A in Green Paranoid Thought Scale, was listed as a secondary outcome in the trial protocol, here on Clinicaltrials.gov and in the approval from the Committee on Health Research Ethics of the Capital Region Denmark. During our trial, our impressions in the clinical assessments were, that ideas of social reference seem to be a more appropriate primary outcome due to our population including people diagnosed with schizotypal disorders along with participants with manifest psychotic disorders. We observed that participants with schizotypal disorders experiencing ideas of social reference, that are more attenuated paranoid ideations, would often receive a low score on the GPTS part B. Therefore, listing GPTS part B as primary outcome would hypothetically only reflect the symptom level of part of the study population (patients with manifest psychosis), while not fully comprising the symptom level, and potential for change, found in the population of patients with schizotypal disorder. '' As of February, 23 2022, 10 months into the trial, where 79 participants out of 256 were included and had participated in baseline assessments, we decided after thorough consideration to exchange our primary outcome, GPTS part B, ideas of persecution, with our secondary outcome, GPTS part A, ideas of social reference, as this was intended to capture the symptom level in the total study population. The exchange did not affect participation in our trial or the informed consent. Intervention in both groups and measurements were unchanged. The two outcomes constitute together GPTS and the unifying concept we attempt to treat, namely paranoid ideations. As this is a blinded, methodologically sound trial, we had not (and still have not throughout the study period) access to preliminary data and therefore no knowledge of the distribution of our two intervention groups nor the potential effect of the intervention. The power calculation remains unchanged irrespective of the selection of primary outcome. (Ideas of persecution: relevant difference 6.0, SD 17.9, N=128*2, power= 80%). Due to the notions mentioned above, we did not find any reasons for ethical implications of the change of primary outcome - as we also were fully transparent with this change of outcome here on Clinicaltrials.gov. We therefore assumed that our ethical committee would approve of this change. However, on September 3 2022 we received a rejection from the Committee on Health Research Ethics of the Capital Region Denmark on changing outcomes, on the invariable grounds that the trial is commenced. This means that it is necessary to keep ideas of persecution, part B in Green Paranoid Thought Scale, as our primary outcome and keep ideas of social reference, part A in Green Paranoid Thought Scale as a secondary outcome. A design paper was published while we had ideas of social reference, part A in Green Paranoid Thought Scale, as a primary outcome. An Update, informing about this significant change in the form of changing back to the originally, approved, primary outcome, is in progress.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomised, assessor-blinded parallel-groups superiority clinical trial.
Masking
Outcomes Assessor
Masking Description
Independent assessors blinded to the treatment will evaluate outcome.
Allocation
Randomized
Enrollment
256 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioural Virtual Reality Therapy (CBT-VR)
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional Cognitive Behavioural Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cognitive Behavioural Virtual Reality Therapy.
Intervention Description
Cognitive Behavioural Therapy augmented with Virtual Reality.
Intervention Type
Other
Intervention Name(s)
Traditional Cognitive Behavioural Therapy
Intervention Description
Traditional Cognitive Behavioural Therapy for psychosis.
Primary Outcome Measure Information:
Title
(GPTS) Green Paranoid Thought Scale Part B: Ideas of persecution.
Description
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.
Time Frame
3 months from inclusion
Secondary Outcome Measure Information:
Title
SIAS (Social Interaction Anxiety Scale)
Description
Minimum score: 0 Maximum score: 20*4=80. Item 5,9 and 11 have reverse score. Higher score means worse outcome.
Time Frame
3 and 9 months from inclusion
Title
SBQ (Safety Behaviour Questionnaire)
Description
Minimum score: 0. Maximum score is in theory unlimited depending on the number of identified, specific safety behaviours.
Time Frame
3 and 9 months from inclusion
Title
PSP (Personal and Social Performance Scale)
Description
Minimum score: 1 Maximum score: 100. Higher score means better outcome.
Time Frame
3 and 9 months from inclusion
Title
CANTAB ERT (Emotion Recognition Task)
Time Frame
3 and 9 months from inclusion
Title
(GPTS) Green Paranoid Thought Scale Part A: Ideas of social reference
Description
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 delusion. Higher score means worse outcome.
Time Frame
3 and 9 months from inclusion
Title
(GPTS) Green Paranoid Thought Scale Part B: Ideas of persecution
Description
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 delusion. Higher score means worse outcome.
Time Frame
9 months from inclusion
Other Pre-specified Outcome Measures:
Title
CDSS (Calgary Depression Scale for Schizophrenia)
Description
Minimum score: 0 Maximum score: 9*3 = 27. Higher score means worse outcome.
Time Frame
3 and 9 months from inclusion
Title
BNSS (Brief Negative Symptom Scale)
Description
13 items with a score from minimum 0 to maximum 6 for each item. Higher score means worse outcome.
Time Frame
3 and 9 months from inclusion
Title
COGDIS (Cognitive disturbances scale)
Description
Score of 0-6 indicate a range. Minimum score: 0 Maximum score: 9*6 = 54. Higher score means worse outcome. Trait phenomenons are coded with a "7", unknown degree of severly is coded with a "8" and uncertainty whether the symptom is present is coded with a "9".
Time Frame
3 and 9 months from inclusion
Title
SAPS (Scale for the Assesment of Positive symptoms)
Description
Composite total score: Minimum score: 0 Maximum score: 30*5 = 150. Higher score means worse outcome. Global score: Minimum score: 0 Maximum score: 4*5 = 20. Higher score means worse outcome.
Time Frame
3 and 9 months from inclusion
Title
Trustworthiness Scale
Description
Minimum score: -3*42=-126 Maximun score: +3*42=126. Higher positive score means better outcome. Higher negative score means worse outcome.
Time Frame
3 and 9 months from inclusion
Title
DACOBS (Davos Assessment of the Cognitive Biases Scale)
Description
Total score: Minimum score: 1*42=42. Maximum score:7*42=294. Higher score means worse outcome. Subscales of: Jumping to conclusions bias: Item 3+8+16+18+25+30 Belief Inflexibility bias: Item 13+15+26+34+38+41 Attention for Threat bias: Item 1+2+6+10+20+37 External Attribution bias: Item 7+12+17+22+24+29 Social Cognition problems: Item 4+9+11+14+19+39 Subjective Cognitive problems: Item 5+21+28+32+36+40 Safety behaviors: Item 23+27+31+33+35+42
Time Frame
3 and 9 months from inclusion
Title
SIDAS (Suicidal Ideation Attributes Scale)
Description
Minimum score: 0. Maximum score: 50. Item 2 has a reverse score. Higher score means worse outcome.
Time Frame
3 and 9 months from inclusion
Title
BCSS (The Brief Core Schema Scales: Beliefs about self and others)
Description
Items with negative belief of self and others: Minimum score: 0. Maximum score: 2*6*4= 48. Higher score means worse outcome. Items with Positive belief of self and others: Minimum score: 0. Maximum score: 2*6*4= 48. Higher score means better outcome.
Time Frame
3 and 9 months from inclusion
Title
SSPA (Social Skills Performance Assessment)
Description
Scene I: Minimum score: 1*8=8. Maximum score: 5*8:40. Higher score means better outcome. Scene II: Minimum score: 1*9=9. Maximum score: 5*9:45. Higher score means better outcome.
Time Frame
3 and 9 months from inclusion
Title
TALE (Trauma And Life Events checklist)
Time Frame
Baseline measure
Title
IBT (Intentionality Bias Task)
Time Frame
3 and 9 months from inclusion
Title
(R-GPTS) Revised Green Paranoid Thought Scale
Description
Minimum total score: 0. Maximum total score: 4*18=72. Part A (Ideas of social reference) minimum score: 0 and maximum score: 4*8=32. Part B (Ideas of persecution) minimum score 0 and maximum score: 4*10=40. Part B score = or > 18 are assumed to be threshold for development of delusion. Higher score means worse outcome.
Time Frame
3 and 9 months from inclusion
Title
GSE (General Self Efficacy Scale)
Description
Minimum score: 1*10=10. Maximum score: 4*10=40. Higher score means better outcome.
Time Frame
3 and 9 months from inclusion
Title
Big-5 (personality traits)
Description
5 spectrums of personality traits assessed with 5 items each. Minimum score for each personality trait: Minimum score: 1*5=5. Maximum score: 5*5=25 Certain items have reverse scores.
Time Frame
3 and 9 months from inclusion
Title
EQ-5D-5L (EuroQOL five dimensions questionnaire)
Description
Scoring the descriptive system: Minimum score: 1-1-1-1-1. Maximum score: 5-5-5-5-5. Higher score means worse outcome. Scoring the VAS: Minimum score: 0. Maximum score: 100. Higher score means better outcome.
Time Frame
3 and 9 months from inclusion
Title
WHO (World Health Organization 5)
Description
Minimum score: 0. Maximum score: 5*5*4=100. Higher score means better outcome.
Time Frame
3 and 9 months from inclusion
Title
CSQ (Client Satisfaction Questionnaire)
Time Frame
3 months follow-up
Title
SFS (The Social Functioning Scale)
Description
Minimum raw score: 0. Maximum raw score: 15+9+39+45+66+39+19=223. Higher score means better outcome.
Time Frame
3 and 9 months from inclusion

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 - years Ability to give informed consent A schizophrenia spectrum disorder (ICD-10 code: F20 -F29) Green Paranoid Thought Scale total score ≥ 40 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ulrik N Jeppesen, MD
Phone
+4520631590
Ext
+45
Email
ulrik.nykjaer.jeppesen@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Louise B Glenthøj, PhD
Email
Louise.Birkedal.Glenthoej@regionh.dk
Facility Information:
Facility Name
Copenhagen Research Center for Mental Health - CORE
City
Copenhagen
State/Province
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35971137
Citation
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.
Results Reference
derived

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

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