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

NCT03585127 | Completed

• 1 other identifier: IPPM 16-17 - 06
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Auditory Hallucination, Verbal; Treatment-resistant Schizophrenia

Keywords

Auditory verbal hallucinations; Schizophrenia; Treatment-resistant; Psychotherapy; Cognitive Behavioral Therapy; Avatar Therapy; Virtual reality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Other Outcomes (1)

• Change in Igroup Presence Questionnaire (IPQ)

  At the end of each Avatar Therapy session

Study Arms (2)

Cognitive Behavioral Therapy

ACTIVE COMPARATOR

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

Behavioral: Cognitive Behavioral Therapy

Avatar Therapy

EXPERIMENTAL

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

Behavioral: Avatar Therapy

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

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.

Also known as: CBT for psychosis

Cognitive Behavioral Therapy

Avatar Therapy BEHAVIORAL

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.

Avatar Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead
• Otsuka Canada Pharmaceutical Inc.: collaborator

Study Sites (1)

Institut Universitaire en Santé Mentale de Montréal

Montreal, Quebec, H1N 3M5, Canada

Location

Related Publications (1)

• 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.

  PMID: 36102593 DERIVED

MeSH Terms

Conditions

Hallucinations; Schizophrenia, Treatment-Resistant; Schizophrenia

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Alexandre Dumais, MD, Ph.D

  Institut Philippe Pinel de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist, Clinical Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 12, 2018
• Study Start: March 1, 2017
• Primary Completion: March 31, 2020
• Study Completion: July 1, 2020
• Last Updated: July 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)