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

Not Applicable

Completed

• Conditions: Auditory Hallucination, Verbal; Treatment-resistant Schizophrenia
• Interventions: Behavioral: Avatar Therapy; Behavioral: Cognitive Behavioral Therapy

• Registration Number: NCT03585127
• Lead Sponsor: Ciusss de L'Est de l'Île de Montréal

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2018-07-02
• Study First Submitted QC: 2018-07-02
• Study First Posted: 2018-07-12
• Primary Completion: 2020-03-31
• Status Verified: 2020-07
• Study Completion: 2020-07-01
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Avatar Therapy	Avatar Therapy	Avatar Therapy consists of 9 weekly sessions: one avatar creation session and 8 therapeutic sessions of one hour.
Cognitive Behavioral Therapy	Cognitive Behavioral Therapy	Cognitive Behavioral Therapy comprises of nine weekly sessions of an hour.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Institut Universitaire en Santé Mentale de Montréal; 🇨🇦 Montréal, Quebec, Canada