Avatar Therapy in Comparison to Cognitive Behavioral Therapy for Treatment-resistant Schizophrenia

Treatment-resistant Schizophrenia Clinical Trial

Official title:

A Pilot Randomized Controlled Study to Compare Avatar Therapy and Cognitive Behavioral Therapy in Patients With Treatment-resistant Schizophrenia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03585127
• Other study ID #: IPPM 16-17 - 06
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2020
• Source: Ciusss de L'Est de l'Île de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: July 1, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Auditory Hallucination, Verbal
• Hallucinations
• Schizophrenia
• Treatment-resistant Schizophrenia

Intervention

Behavioral:
• Cognitive Behavioral Therapy
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.
• Avatar Therapy
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.

Locations

Country	Name	City	State
Canada	Institut Universitaire en Santé Mentale de Montréal	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Ciusss de L'Est de l'Île de Montréal	Otsuka Canada Pharmaceutical Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Igroup Presence Questionnaire (IPQ)	14-item scale measuring the sense of presence; Range 0-84, Higher values indicate a stronger feeling of presence	At the end of each Avatar Therapy session
Primary	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	Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Secondary	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	Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Secondary	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	Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Secondary	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	Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Secondary	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	Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Secondary	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	Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months