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CompletedNCT03348787AcceptVoiceUpdated Jul 30, 2020

Behavioral and Cognitive Therapies for Auditory Hallucination Management

An interventional study of Behavioral and Cognitive Therapies in Chronic Psychosis, sponsored by University Hospital, Toulouse. Completed at 5 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-07-30.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Psychosis

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Keywords

  • Behavioral and Cognitive Therapies
03

In context

Behavior

1,573 studies on the registry are indexed under Behavior; 313 are open to participants now.

This study's enrollment of 55 is below the median of 120 across 1,197 interventional studies indexed under Behavior.

Browse Behavior studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Mental retardation
  • Subject participating in another search including an exclusion period still in progress at pre-inclusion
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    Behavioral and Cognitive Therapies

    Chronic psychotic patients will have Behavioral and Cognitive Therapies

    Behavioral: Behavioral and Cognitive Therapies

Interventions

  • BehavioralBehavioral and Cognitive Therapies

    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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Until 12 months after the last session

07

Study locations

5 sites
  • Lannemezan Hospital
    Lannemezan, 65300, France
  • Lavaur Hospital
    Lavaur, 81502, France
  • Sainte-Marie de Rodez Hospital
    Rodez, 12032, France
  • Ariège-Couserans Hospital
    Saint-Lizier, 09190, France
  • Gérard Marchand Hospital
    Toulouse, 31057, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Dec 2019, 23 months.

Of 741 non-industry interventional studies with no phase under Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 32. This study's 23 months is above that.

Counting every sponsor, half of 757 studies reached it within 13 months; a quarter within 5 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 14, 2017
First posted
Nov 21, 2017
StartActual
Dec 13, 2017
Primary completionActual
Dec 5, 2019
CompletionActual
Jun 30, 2020
Last update
Jul 30, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03348787
Responsible party
Sponsor
First posted
Nov 21, 2017
Start date
Dec 13, 2017
Primary completion
Dec 5, 2019
Completion
Jun 30, 2020
Last update
Jul 30, 2020

Study contacts

Axel Bourcier, PhD
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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