Clinical trial NCT06917209: Evaluation of the Efficacy of Dissociation-Focused Cognitive Behavior Therapy: a Multicenter Randomized Controlled Trial
Official title: Evaluation of the Efficacy of Dissociation-Focused Cognitive Behavior Therapy: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dissociative Disorder
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dissociative symptoms and disorders are particularly prevalent in the general population and among people suffering from psychiatric disorders. To date, no treatment has proven effective for this type of problem. Exploratory studies (without control group) have been carried out. Among these studies, dissociation-focused cognitive behavioral therapy (DF-CBT) seems promising. DF-CBT is based on a solid empirical model that has received numerous scientific evidence.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years
* Membership of a social security scheme
* Participant's express consent
* Have at least one diagnosis of dissociative disorder among the following:

depersonalization/derealization disorder, dissociative identity disorder, unspecified dissociative disorder.

* Be able to carry out psychotherapy sessions.
* If taking psychiatric medication, treatment must have been stable for at least 30 days.

Exclusion Criteria:

* Present one of the following current diagnoses: substance use disorder (excluding tobacco), neurodevelopmental disorder, anorexia nervosa, severe depressive disorder, schizophrenia spectrum disorder, bipolar disorder, personality disorder other than borderline personality disorder.
* Present cognitive deficits.
* Be engaged in psychotherapeutic work.
* Be undergoing benzodiazepine treatment.

Primary outcomes:
measure: Difference in Dissociative Experience Scale (DES)
timeFrame: Between randomization and 3 months after
Secondary outcomes:
measure: Hetero-administered visual analogue scale
timeFrame: At randomization, 3 months and 6 months after
measure: Dissociation Questionnaire (DIS-Q)
timeFrame: At randomisation, 3 months and 6 months after
measure: Hospital Anxiety Depression Scale (HADS)
timeFrame: Randomization, 3 months and 6 months after
measure: Post traumatic stress disorder checklist scale (PCL-5)
timeFrame: Randomization, 3 months and 6 months after
measure: Satisfaction With Life Scale (SWLS)
timeFrame: Randomization, 3 months and 6 months after
measure: Dissociative Experiences Scale (DES)
timeFrame: At 6 months after randomization
Other outcomes:
Locations:
Study officials:
affiliation: Clinique Psychiatrique Universitaire - CHRU de Tours
name: Alexis VANCAPPEL, PhD
role: STUDY_CHAIR
affiliation: Clinique Psychiatrique Universitaire CPU / CHRU de Tours
name: Wissam EL HAGE, MD, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Régional du Psychotraumatisme CRP / CHRU TOURS
name: Lyna CHAMI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Psychiatrie / CHU ANGERS
name: François KAZOUR, MD, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre régional du Psychotraumatisme des Hauts de France / CHU LILLE
name: Arnaud LEROY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Urgences psychiatrique / CHU MONTPELLIER
name: Matthieu FRAIGNEAU, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unité de neuromodulation en psychiatrie / CHU NANTES
name: Anne SAUVAGET, MD, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre départemental de Psychotraumatologie (unité TCC) / ORLEANS
name: Sophie LAPUJOULADE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Régional du Psychotraumatisme du Grand Est / CHU STRASBOURG
name: Amaury MENGIN, MD
role: PRINCIPAL_INVESTIGATOR
References: