Approximately 25-50% of patients with schizophrenia experience treatment-resistant Auditory Verbal Hallucinations (AVHs), which contribute to the development of associated psychopathological disorders (e.g., anxiety, depression, suicidal ideation). Various validated psychotherapeutic strategies and tools for managing treatment-resistant AVHs have been combined into an integrative therapeutic program. The main objective of this study is to evaluate the efficacy of this program in reducing the frequency and intensity of AVHs, as well as its impact on comorbid psychopathology (e.g., depression, anxiety, self-esteem, substance use) in patients with schizophrenia or schizoaffective disorder who experience treatment-resistant AVHs.
The present study is a multicenter, prospective, randomized trial with two groups. Its main objective is to evaluate the efficacy of an integrative group therapy for drug-resistant Auditory Verbal Hallucinations (AVHs) in patients with schizophrenia or schizoaffective disorder. A total of 114 patients will be randomly assigned to the experimental or control group. The experimental group will receive integrative therapy sessions, while the control group will participate in an audio-visual group reflecting usual care. Both experimental and control groups will attend fifteen weekly 1.5-hour sessions, supervised by a psychologist and a nurse trained in, or at least familiar with, cognitive-behavioral therapy. The sessions for the experimental group are organized as follows: Sessions 1-2: Psychoeducation about AVHs Sessions 3-6: Metacognitive training Sessions 7-9: Monitoring voices using a notebook Session 10: Gaining control over voices through attentional distraction Session 11: Voice avatar creation Sessions 12-13: Dialogue with voices Session 14: Compassion-based mindfulness Session 15: Living with voices and community integration
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
116
Integrative group therapy includes 15 sessions weekly, 1.5 hours sessions supervised by one psychologist and one nurse, trained in or at least familiar with cognitive-behavioural therapy.
Public Mental Health Institution of Guadeloupe
Les Abymes, Guadeloupe
Change in Phenomenological Features of Auditory Verbal Hallucinations (AVHs)
Change in Phenomenological Features of Auditory Verbal Hallucinations (AVHs) Changes in the severity, intensity, frequency, and associated distress of AVHs will be assessed using the Psychotic Symptom Rating Scale - Auditory Hallucinations subscale (PSYRATS-AH). The PSYRATS-AH includes 11 items, each rated on a 0-4 Likert scale (total score range: 0 to 44), where higher scores indicate more severe hallucination-related symptomatology. All evaluations will be performed by an investigator blinded to group allocation to ensure unbiased assessment of treatment effects.
Time frame: Baseline (before the intervention, D1), one month after the end of the intervention (D2), and six months after the end of the intervention (D3).
Belief and Trust in AVHs
Belief and Trust in Auditory Verbal Hallucinations (AVHs) Beliefs about and trust in AVHs will be assessed using the Beliefs About Voices Questionnaire-Revised (BAVQ-R). The BAVQ-R evaluates participants' beliefs, emotional responses, and behavioral engagement with voices. Each item is rated on a 0-4 Likert scale, with a total score range of 0 to 56, where higher scores indicate stronger beliefs in, or greater trust toward, the voices. All assessments will be conducted by an investigator blinded to group assignment to ensure unbiased evaluation.
Time frame: Baseline (D1), one month after the end of the intervention (D2), and six months after the end of the intervention (D3).
Attitudes and Reactions Towards AVHs
Attitudes and Reactions Towards Auditory Verbal Hallucinations (AVHs) Attitudes toward and behavioral reactions to AVHs will be assessed using the Voice Attitude and Action Scale - 9 items (VAAS-9). Each item is rated on a 0-4 Likert scale, resulting in a total score range of 0 to 36, where higher scores indicate more adaptive attitudes and actions toward voices. All assessments will be performed by an investigator blinded to group assignment to ensure unbiased measurement.
Time frame: Baseline (D1), one month after the end of the intervention (D2), and six months after the end of the intervention (D3).
Depression
Depressive symptoms will be assessed using the Calgary Depression Scale for Schizophrenia (CDSS). The CDSS consists of 9 items, each scored on a 0-3 scale, resulting in a total score range of 0 to 27, where higher scores indicate more severe depressive symptoms. All assessments will be conducted by an investigator blinded to group assignment to ensure unbiased evaluation.
Time frame: Baseline (D1), one month after the end of the intervention (D2), and six months after the end of the intervention (D3).
Self-Esteem
Self-esteem will be assessed using the Rosenberg Self-Esteem Scale (RSES). The scale includes 10 items, each rated on a 0-3 Likert scale, resulting in a total score range of 0 to 30, where higher scores indicate higher self-esteem. All assessments will be conducted by an investigator blinded to group assignment to ensure unbiased measurement.
Time frame: Baseline (D1), one month after the end of the intervention (D2), and six months after the end of the intervention (D3).
Subjective Quality of Life
Subjective quality of life will be assessed using the World Health Organization Quality of Life Instrument - WHOQOL-BREF. The WHOQOL-BREF includes 26 items across four domains (physical health, psychological health, social relationships, and environment), with each item rated on a 1-5 Likert scale, resulting in domain scores that can be transformed to a 0-100 scale, where higher scores indicate better quality of life. All assessments will be conducted by an investigator blinded to group assignment to ensure unbiased evaluation.
Time frame: Baseline (D1), one month after the end of the intervention (D2), and six months after the end of the intervention (D3).
Exploratory Outcome: Substance Use
Changes over time in substance use will be assessed using the Alcohol, Smoking and Substance Involvement Screening Test - Version 3 (ASSIST V3.0). The ASSIST V3.0 evaluates the frequency and risk level of substance use across multiple substances (e.g., alcohol, tobacco, cannabis, cocaine, opioids, stimulants, sedatives). Each item is scored according to substance-specific guidelines, resulting in risk scores ranging from 0 to 39 for each substance, where higher scores indicate greater risk or more severe substance use involvement. All assessments will be conducted by an investigator blinded to group assignment to ensure unbiased evaluation.
Time frame: Baseline (D1 - before intervention); One month after the end of the intervention (D2); Six months after the end of the intervention (D3)
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