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

Ciusss de L'Est de l'Île de Montréal

Status: Completed

Conditions: Auditory Hallucination, Verbal; Treatment-resistant Schizophrenia

Treatments: Behavioral: Avatar Therapy; Behavioral: Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03585127

IPPM 16-17 - 06

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Cognitive Behavioral Therapy

Active Comparator group

Description:

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

Treatment:

Behavioral: Cognitive Behavioral Therapy

Avatar Therapy

Experimental group

Description:

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

Treatment:

Behavioral: Avatar Therapy