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

Sponsor

Ciusss de L'Est de l'Île de Montréal (Other)

Overall Status

Completed

CT.gov ID

NCT03585127

Collaborator

Otsuka Canada Pharmaceutical Inc. (Industry)

Enrollment

Location

Arms

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Auditory Hallucination, Verbal Treatment-resistant Schizophrenia	Behavioral: Cognitive Behavioral Therapy Behavioral: Avatar Therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2017

Actual Primary Completion Date :

Mar 31, 2020

Actual Study Completion Date :

Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cognitive Behavioral Therapy Cognitive Behavioral Therapy comprises of nine weekly sessions of an hour.	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. Other Names: CBT for psychosis
Experimental: Avatar Therapy Avatar Therapy consists of 9 weekly sessions: one avatar creation session and 8 therapeutic sessions of one hour.	Behavioral: 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.

Arm

Intervention/Treatment

Active Comparator: Cognitive Behavioral Therapy

Cognitive Behavioral Therapy comprises of nine weekly sessions of an hour.

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.

Other Names:

CBT for psychosis

Experimental: Avatar Therapy

Avatar Therapy consists of 9 weekly sessions: one avatar creation session and 8 therapeutic sessions of one hour.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

Change in Psychotic Symptom Rating Scale (PSYRATS) - auditory hallucinations [Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months]
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) [Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months]
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) [Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months]
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) [Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months]
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) [Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months]
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 [Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months]
25-item self-reported scale measuring the feeling of empowerment; Range 25-100, Higher values indicate a stronger feeling of empowerment

Other Outcome Measures

Change in Igroup Presence Questionnaire (IPQ) [At the end of each Avatar Therapy session]
14-item scale measuring the sense of presence; Range 0-84, Higher values indicate a stronger feeling of presence

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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