Mental DisorderPROGEVsNCT07266376
Validation of a VOICE MAnagement Program in Schizophrenia VVoice MAPS
A study testing Integrative group therapy in people with Mental Disorder and Schizophrenia Diagnosis, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorder, Schizophrenia Diagnosis
- What is being tested?
- Integrative group therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteGuadeloupe
- Study dates
- 5 Jan 2026to 5 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting patients over 18 years of age will be enrolled in the study if they meet all of the following criteria:
- Diagnosis: Fulfill DSM-5 criteria for schizophrenia or schizoaffective disorder.
- Resistant AVHs: Present treatment-resistant auditory verbal hallucinations (AVHs), defined as the persistence of daily hallucinations without remission despite adequate antipsychotic medication for at least 3 months.
- Motivation: Express a request for relief from voices.
- Treatment Setting: Are outpatients being treated in psychiatric departments at the Public Mental Health Institution of Guadeloupe or the University Hospital Center of Nîmes.
- Severity: Have a score of greater than 9 on the Psychotic Symptom Rating Scale - Auditory Hallucinations subscale (PSYRATS-AH).
Who cannot join
- Patients will be excluded from the study if they meet any of the following criteria:
- Participation in another study: Currently taking part in another clinical trial or within the exclusion period of another study.
- Consent refusal: Refuse to sign the written informed consent.
- Inability to provide informed consent: Failure or impossibility to provide the patient with sufficient information to allow an informed decision.
- Severe substance abuse: Presence of severe substance use disorder.
- Acute somatic decompensation: Experiencing an acute medical condition that may compromise participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Guadeloupe1 site
Public Mental Health Institution of Guadeloupe
Les Abymes, 97139
Sabrina Jumentier, PhD, +33679342982, sabrina.jumentier@epsm-guadeloupe.fr
Jumentier
About this study
Official title: Validation of a VOICE MAnagement Program in Schizophrenia
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.
Read the detailed description
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
- Conditions
- Mental Disorder, Schizophrenia Diagnosis
- Being tested
- Integrative group therapy
- Keywords
- Schizophrenia, Auditory Verbal Hallucinations, Groupal Intervention, Integrative Approach
- Medical subject headings
- Mental Disorders, Schizophrenia, Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative group therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Media-workshop control group | No intervention | 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. |
| Psychoeducation & Metacognitive Training | Experimental | 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). Receives: Behavioral: Integrative group therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (before the intervention, D1), one month after the end of the intervention (D2), and six months after the end of the intervention (D3).
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (D1 - before intervention); One month after the end of the intervention (D2); Six months after the end of the intervention (D3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start5 Jan 2026 (estimated)
- Primary completion5 Jan 2027 (estimated)
- Study completion5 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients randomly assigned to the media-workshop control group will participate in 15 weekly sessions (1.5 hours each), which consist of commenting on two short episodes of the TV series Malcolm in the Middle. This early-2000s show depicts the daily life of a lower-middle-class American family. The purpose of the sessions is to enhance social cognition by practicing the reading of intentions, identifying clues supporting hypotheses, discussing these hypotheses, and considering alternative explanations.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Collaborators
- GIRCI SOHO
- Responsible party
- Sponsor
- Investigators
- Sabrina Jumentier, PhD, Study director, Public Mental Health Institution of Guadeloupe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266376
- Sponsor's protocol ID
- PAP_RI2_2021/16
- Acronym
- PROGEVs
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a VOICE MAnagement Program in Schizophrenia
- ClinicalTrials.gov ID
- NCT07266376
- Acronym / sponsor ID
- PROGEVs / PAP_RI2_2021/16
- Conditions
- Mental Disorder, Schizophrenia Diagnosis
- Keywords
- Schizophrenia, Auditory Verbal Hallucinations, Groupal Intervention, Integrative Approach
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Collaborators
- GIRCI SOHO
- Study start
- 5 Jan 2026 (estimated)
- Primary completion
- 5 Jan 2027 (estimated)
- Study completion
- 5 Jan 2027 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients randomly assigned to the media-workshop control group will participate in 15 weekly sessions (1.5 hours each), which consist of commenting on two short episodes of the TV series Malcolm in the Middle. This early-2000s show depicts the daily life of a lower-middle-class American family. The purpose of the sessions is to enhance social cognition by practicing the reading of intentions, identifying clues supporting hypotheses, discussing these hypotheses, and considering alternative explanations.
| Arm | Type | Receives |
|---|---|---|
| Media-workshop control group | No intervention | –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. |
| Psychoeducation & Metacognitive Training | Experimental | Behavioral: Integrative group therapyExperimental 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Consenting patients over 18 years of age will be enrolled in the study if they meet all of the following criteria:
- Diagnosis: Fulfill DSM-5 criteria for schizophrenia or schizoaffective disorder.
- Resistant AVHs: Present treatment-resistant auditory verbal hallucinations (AVHs), defined as the persistence of daily hallucinations without remission despite adequate antipsychotic medication for at least 3 months.
- Motivation: Express a request for relief from voices.
- Treatment Setting: Are outpatients being treated in psychiatric departments at the Public Mental Health Institution of Guadeloupe or the University Hospital Center of Nîmes.
Key exclusion criteria (6 listed)
- Participation in another study: Currently taking part in another clinical trial or within the exclusion period of another study.
- Consent refusal: Refuse to sign the written informed consent.
- Inability to provide informed consent: Failure or impossibility to provide the patient with sufficient information to allow an informed decision.
- Severe substance abuse: Presence of severe substance use disorder.
- Acute somatic decompensation: Experiencing an acute medical condition that may compromise participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrative group therapyIntegrative 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. | Behavioural | Psychoeducation & Metacognitive Training |
Primary outcome
Change in Phenomenological Features of Auditory Verbal Hallucinations (AVHs)
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).
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.
6 secondary outcomes
Belief and Trust in AVHs
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
Time frame: Baseline (D1), one month after the end of the intervention (D2), and six months after the end of the intervention (D3).
Depression
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
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
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
Time frame: Baseline (D1 - before intervention); One month after the end of the intervention (D2); Six months after the end of the intervention (D3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sabrina Jumentier, PhD study director
Public Mental Health Institution of Guadeloupe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative group therapy in people with Mental Disorder and Schizophrenia Diagnosis, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact melanie petapermal, MD (+590590934667, melanie.petapermal@chu-guadeloupe.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Phenomenological Features of Auditory Verbal Hallucinations (AVHs) (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.