An interventional study of Integrative group therapy in Mental Disorder and Schizophrenia Diagnosis, sponsored by Centre Hospitalier Universitaire de la Guadeloupe. Not yet recruiting at 1 site in Guadeloupe. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by Centre Hospitalier Universitaire de la Guadeloupe · Not applicable, Interventional, and Treatment
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
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 116 is above the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Centre Hospitalier Universitaire de la Guadeloupe is the lead sponsor of 50 studies on the registry; 25 are open to participants now.
Compared within Schizophrenia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Mental Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Consenting patients over 18 years of age will be enrolled in the study if they meet all of the following criteria:
Exclusion Criteria :
Patients will be excluded from the study if they meet any of the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomly assigned to the media-workshop control group will participate in 15 weekly sessions (1.5 hour per session) consisting in commenting two short episodes from the series "Malcolm in the middle". This early 2000 TV show exposes the daily life of a low middle class American family. The purpose is to focus on social cognition through the reading of intentions, identification of clues supporting any hypotheses, discuss these hypotheses or even identify alternative hypotheses.
Experimental group sessions are organized as follow : Psychoeducation of AVHs (sessions 1 and 2); Metacognitive training (sessions 3 to 6); Paying attention to voices through the use of a notebook (sessions 7 to 9); Taking control over the voices through - Attentional Distraction (session 10); Voice avatar creation (session 11); Dialogue with voices (sessions 12 \& 13); Compassion-based mindfulness (session 14); Living with voices and community integration (session 15).
Behavioral: Integrative group therapy
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.
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)
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de la Guadeloupe