Avatar Therapy in Comparison to Cognitive Behavioral Therapy for Treatment-resistant Schizophrenia
Primary Purpose
Auditory Hallucination, Verbal, Treatment-resistant Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Avatar Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Auditory Hallucination, Verbal focused on measuring Auditory verbal hallucinations, Schizophrenia, Treatment-resistant, Psychotherapy, Cognitive Behavioral Therapy, Avatar Therapy, Virtual reality
Eligibility Criteria
Inclusion Criteria:
- distressing auditory verbal hallucinations
- medication resistance relating to auditory verbal hallucinations (no response after 3 antipsychotics trials lasting at least 4 weeks each with a minimum of 400mg chlorpromazine equivalent)
- DSM-5 diagnosis of schizophrenia or schizoaffective disorder
Exclusion Criteria:
- any change in medication within the past 2 months;
- substance use disorder within the last 12 months
- neurological disorder or unstable and serious physical illness
- ongoing psychotic episode
- Cognitive Behavioral Therapy for psychosis within the last 12 months
Sites / Locations
- Institut Universitaire en Santé Mentale de Montréal
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Cognitive Behavioral Therapy
Avatar Therapy
Arm Description
Cognitive Behavioral Therapy comprises of nine weekly sessions of an hour.
Avatar Therapy consists of 9 weekly sessions: one avatar creation session and 8 therapeutic sessions of one hour.
Outcomes
Primary Outcome Measures
Change in Psychotic Symptom Rating Scale (PSYRATS) - auditory hallucinations
11-item structured interview assessing the severity of auditory hallucinations; Range 0-44, Higher values indicate a worse outcome
Secondary Outcome Measures
Change in Beliefs About Voices Questionnaire - Revised (BAVQ-R)
35-item self-reported measure designed to assess key beliefs and responses people have concerning their voice; Range 0-105, Higher scores indicate more beliefs and responses toward their voice
Change in Positive And Negative Syndrome Scale (PANSS)
30-item semi-structured interview investigating overall symptoms severity of schizophrenia in the last week; Range 30-210, Higher values indicate a more severe symptomatology
Change in Beck Depression Inventory - II (BDI-II)
21-item self-reported measure assessing depression symptoms over the past 2 weeks; Range 0-63, Higher values indicate more severe depressive symptomatology
Change in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF)
16-item self-reported scale measuring enjoyment and satisfaction experienced during the past week in various areas of daily functioning; Range 14-70, Higher values indicate a better satisfaction of life
Change in Empowerment scale (Making Decisions) - Revised Short Form
25-item self-reported scale measuring the feeling of empowerment; Range 25-100, Higher values indicate a stronger feeling of empowerment
Full Information
NCT ID
NCT03585127
First Posted
July 2, 2018
Last Updated
July 15, 2020
Sponsor
Ciusss de L'Est de l'Île de Montréal
Collaborators
Otsuka Canada Pharmaceutical Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03585127
Brief Title
Avatar Therapy in Comparison to Cognitive Behavioral Therapy for Treatment-resistant Schizophrenia
Official Title
A Pilot Randomized Controlled Study to Compare Avatar Therapy and Cognitive Behavioral Therapy in Patients With Treatment-resistant Schizophrenia.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ciusss de L'Est de l'Île de Montréal
Collaborators
Otsuka Canada Pharmaceutical Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Schizophrenia is associated with long-lasting health, social and financial burden for patients, families, caregivers and society. Unfortunately, 25-30% of schizophrenia patients respond poorly to antipsychotic medication. Moreover, psychotherapeutic treatment alternatives are very limited for this suffering population. This unmet clinical need requires innovation and action. Psychotherapeutic treatment alternatives such as Cognitive Behavior Therapy (CBT) provide at best moderate results. Using immersive virtual reality, we recently tested a novel psychotherapeutic intervention, Avatar Therapy (AT), where the therapist engages in a dialogue with the patient through a virtual representation of the patient's distressing voice. This approach, being both relational and experiential, provides a unique opportunity to aid patients gain control over their voice. The results of our pilot study on AT were clinically promising for the severity and distress related to hallucinations, positive symptomatology and emotion regulation. To further research in this field, the primary goal of this randomized-controlled, single-site parallel study is to show that AT is superior to CBT for the treatment of persistent auditory hallucinations in schizophrenia. Our secondary goal is to examine the effects of these interventions on emotion regulation, mood symptoms (anxiety and depression), self-esteem, level of functioning and quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Auditory Hallucination, Verbal, Treatment-resistant Schizophrenia
Keywords
Auditory verbal hallucinations, Schizophrenia, Treatment-resistant, Psychotherapy, Cognitive Behavioral Therapy, Avatar Therapy, Virtual reality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Behavioral Therapy
Arm Type
Active Comparator
Arm Description
Cognitive Behavioral Therapy comprises of nine weekly sessions of an hour.
Arm Title
Avatar Therapy
Arm Type
Experimental
Arm Description
Avatar Therapy consists of 9 weekly sessions: one avatar creation session and 8 therapeutic sessions of one hour.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Other Intervention Name(s)
CBT for psychosis
Intervention Description
Participants will be offered 9 individual and weekly sessions of 1 hour, which will be administered in an individual format by a licensed psychologist or psychiatrist trained in Cognitive Behavioral Therapy for psychosis (CBTp). The program is derived and adapted from current evidence-based treatments for hallucinations. The 9 CBTp sessions will consist of a succession of learning modules and suggested task assignments.
Intervention Type
Behavioral
Intervention Name(s)
Avatar Therapy
Intervention Description
Participants will be offered 9 individual and weekly sessions of 1 hour, which will be administered in an individual format by a licensed psychologist or psychiatrist experienced with psychosis patients. The therapy will consist in prompting participants to enter in a dialogue with their persecutor to better regulate their emotional responses. Over the course of the therapy, the avatar's speech and tone will gradually be changed by the therapist to echo participants' improved ability to regulate their emotions. That is, the avatar will progressively change from being abusive to becoming helpful and supportive. By doing so, the therapy will seek to reinforce participants' feeling of empowerment over their voices.
Primary Outcome Measure Information:
Title
Change in Psychotic Symptom Rating Scale (PSYRATS) - auditory hallucinations
Description
11-item structured interview assessing the severity of auditory hallucinations; Range 0-44, Higher values indicate a worse outcome
Time Frame
Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Secondary Outcome Measure Information:
Title
Change in Beliefs About Voices Questionnaire - Revised (BAVQ-R)
Description
35-item self-reported measure designed to assess key beliefs and responses people have concerning their voice; Range 0-105, Higher scores indicate more beliefs and responses toward their voice
Time Frame
Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Title
Change in Positive And Negative Syndrome Scale (PANSS)
Description
30-item semi-structured interview investigating overall symptoms severity of schizophrenia in the last week; Range 30-210, Higher values indicate a more severe symptomatology
Time Frame
Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Title
Change in Beck Depression Inventory - II (BDI-II)
Description
21-item self-reported measure assessing depression symptoms over the past 2 weeks; Range 0-63, Higher values indicate more severe depressive symptomatology
Time Frame
Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Title
Change in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF)
Description
16-item self-reported scale measuring enjoyment and satisfaction experienced during the past week in various areas of daily functioning; Range 14-70, Higher values indicate a better satisfaction of life
Time Frame
Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Title
Change in Empowerment scale (Making Decisions) - Revised Short Form
Description
25-item self-reported scale measuring the feeling of empowerment; Range 25-100, Higher values indicate a stronger feeling of empowerment
Time Frame
Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Other Pre-specified Outcome Measures:
Title
Change in Igroup Presence Questionnaire (IPQ)
Description
14-item scale measuring the sense of presence; Range 0-84, Higher values indicate a stronger feeling of presence
Time Frame
At the end of each Avatar Therapy session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
distressing auditory verbal hallucinations
medication resistance relating to auditory verbal hallucinations (no response after 3 antipsychotics trials lasting at least 4 weeks each with a minimum of 400mg chlorpromazine equivalent)
DSM-5 diagnosis of schizophrenia or schizoaffective disorder
Exclusion Criteria:
any change in medication within the past 2 months;
substance use disorder within the last 12 months
neurological disorder or unstable and serious physical illness
ongoing psychotic episode
Cognitive Behavioral Therapy for psychosis within the last 12 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Dumais, MD, Ph.D
Organizational Affiliation
Institut Philippe Pinel de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Universitaire en Santé Mentale de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1N 3M5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36102593
Citation
Hudon A, Leveille N, Sanchez-Schicharew K, Dellazizzo L, Phraxayavong K, Dumais A. The impacts of the COVID-19 pandemic on treatment-resistant schizophrenia patients having followed virtual reality therapy or cognitive behavioural therapy: a content analysis. Ann Med. 2022 Dec;54(1):2477-2485. doi: 10.1080/07853890.2022.2121852.
Results Reference
derived
Learn more about this trial
Avatar Therapy in Comparison to Cognitive Behavioral Therapy for Treatment-resistant Schizophrenia
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