Chronic PsychosisAcceptVoiceNCT03348787
Behavioral and Cognitive Therapies for Auditory Hallucination Management
A study testing Behavioral and Cognitive Therapies in people with Chronic Psychosis, run by University Hospital, Toulouse at 5 sites in France.
Trial summary
The present study wants to evaluate the efficacy of a short psychoeducational type group intervention and Cognitive behavioral therapy (CBT) 3rd wave on the severity of hallucinatory Acoustico-Verbal (HAV) symptomatology in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Psychosis
- What is being tested?
- Behavioral and Cognitive Therapies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 5 sitesFrance
- Study dates
- 13 Dec 2017to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Schizophrenic disorders, schizo-affective disorders
- Suffering from persistent HAV
- No change in symptomatology for 3 months.
- No anticipated change in antipsychotic treatment (anti-hallucinatory): olanzapine, risperidone, amisulpride, quetiapine, aripiprazole, loxapine, haloperidol, clopixol, modecate, nozinan, cyamemazine, piportil, clozapine
- Major patient, or major incompetent.
Who cannot join
- Mental retardation
- Subject participating in another search including an exclusion period still in progress at pre-inclusion
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Lannemezan Hospital
Lannemezan, 65300
Lavaur Hospital
Lavaur, 81502
Sainte-Marie de Rodez Hospital
Rodez, 12032
Ariège-Couserans Hospital
Saint-Lizier, 09190
Gérard Marchand Hospital
Toulouse, 31057
About this study
Official title: Behavioral and Cognitive Therapies for Auditory Hallucination Management: Effectiveness and Analysis of Change Processes Involved With Hallucinations in a Population Suffering From Chronic Psychosis
The present study wants to evaluate the efficacy of a short psychoeducational type group intervention and Cognitive behavioral therapy (CBT) 3rd wave on the severity of hallucinatory Acoustico-Verbal (HAV) symptomatology in patients with schizophrenia.
- Conditions
- Chronic Psychosis
- Being tested
- Behavioral and Cognitive Therapies
- Keywords
- Behavioral and Cognitive Therapies
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral and Cognitive TherapiesBehavioural
Group intervention of 6 weekly sessions of one hour and 30 minutes based on the psychoeducational therapeutic principles and CBT type 3 wave "Accept Voices" applied to HAV
| Study group | Role | What they receive |
|---|---|---|
| Behavioral and Cognitive Therapies | Experimental | Chronic psychotic patients will have Behavioral and Cognitive Therapies Receives: Behavioral: Behavioral and Cognitive Therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
intensity HAV symptoms
Difference between the Psychotic Symptom Rating Scales (PSYRATS) on HAV symptom score administered before the first therapeutic group session and the PSYRATS symptom score administered 1 week after the last group session. The PSYRATS Scales measure dimensions of hallucinations and delusions.
Measured: Baseline and one week after the last session
Secondary outcomes (1)
Effect over time
Difference between the PSYRATS score given 1 week before the first session, and the PSYRATS score administered one week after the last session and then at 6 weeks, 6 months and 12 months.
Measured: Until 12 months after the last session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start13 Dec 2017
- Primary completion5 Dec 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PsychosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Axel Bourcier, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348787
- Sponsor's protocol ID
- RC31/17/0159
- Other IDs
- 2017-A01929-44
- Acronym
- AcceptVoice
- Status last verified
- Jul 2020
- First submitted
- 14 Nov 2017
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral and Cognitive Therapies for Auditory Hallucination Management: Effectiveness and Analysis of Change Processes Involved With Hallucinations in a Population Suffering From Chronic Psychosis
- ClinicalTrials.gov ID
- NCT03348787
- Acronym / sponsor ID
- AcceptVoice / RC31/17/0159
- Conditions
- Chronic Psychosis
- Keywords
- Behavioral and Cognitive Therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 5 Dec 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 21 Nov 2017 (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.
The present study wants to evaluate the efficacy of a short psychoeducational type group intervention and Cognitive behavioral therapy (CBT) 3rd wave on the severity of hallucinatory Acoustico-Verbal (HAV) symptomatology in patients with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral and Cognitive Therapies | Experimental | Behavioral: Behavioral and Cognitive TherapiesChronic psychotic patients will have Behavioral and Cognitive Therapies |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Schizophrenic disorders, schizo-affective disorders
- Suffering from persistent HAV
- No change in symptomatology for 3 months.
- No anticipated change in antipsychotic treatment (anti-hallucinatory): olanzapine, risperidone, amisulpride, quetiapine, aripiprazole, loxapine, haloperidol, clopixol, modecate, nozinan, cyamemazine, piportil, clozapine
- Major patient, or major incompetent.
Key exclusion criteria (2 listed)
- Mental retardation
- Subject participating in another search including an exclusion period still in progress at pre-inclusion
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 |
|---|---|---|
| Behavioral and Cognitive TherapiesGroup intervention of 6 weekly sessions of one hour and 30 minutes based on the psychoeducational therapeutic principles and CBT type 3 wave "Accept Voices" applied to HAV | Behavioural | Behavioral and Cognitive Therapies |
Primary outcome
intensity HAV symptoms
Time frame: Baseline and one week after the last session
Difference between the Psychotic Symptom Rating Scales (PSYRATS) on HAV symptom score administered before the first therapeutic group session and the PSYRATS symptom score administered 1 week after the last group session. The PSYRATS Scales measure dimensions of hallucinations and delusions.
1 secondary outcome
Effect over time
Time frame: Until 12 months after the last session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Chronic Psychosis
Recruiting
Neuronavigated rTMS for Treatment-Resistant Auditory Hallucinations
Schizophrenia, Auditory Verbal Hallucinations
Not yet recruiting
Pharmacist-led Interventions in Psychiatric Patients
Mental Disorders, Metabolic Syndrome
Not yet recruiting
PQQ for Cognitive and Negative Symptoms
Schizophrenia, Cognitive Symptoms
Recruiting
CBT-CP for Veterans With SMI
Chronic Pain, Schizophrenia
RecruitingObservational study
Neurophysiologic Biomarkers for Cognitive Rehabilitation
Schizophrenia Spectrum Disorders
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. This study is not recruiting at the moment.
Axel Bourcier, PhD principal investigator
University Hospital, Toulouse
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral and Cognitive Therapies in people with Chronic Psychosis, run by University Hospital, Toulouse at 5 sites in France.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intensity HAV symptoms (time frame: Baseline and one week after the last session). 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 30 Jul 2020.