Evaluation of the Efficacy of Dissociation-Focused Cognitive Behavior Therapy: a Multicenter Randomized Controlled Trial

NCT ID: NCT06917209

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-22
• Study Completion Date: 2027-04-22

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.

Conditions

Dissociative Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

The experimental group will receive 9 weekly sessions of DF-CBT psychotherapy.

Group Type: EXPERIMENTAL

CBT-CD psychotherapy

Intervention Type: OTHER

9 weekly sessions of CBT-CD psychotherapy

The control group will receive 9 weekly relaxation sessions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CBT-CD psychotherapy

9 weekly sessions of CBT-CD psychotherapy

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Tours

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexis VANCAPPEL, PhD

Role: STUDY_CHAIR

Clinique Psychiatrique Universitaire - CHRU de Tours

Wissam EL HAGE, MD, PhD, Professor

Role: PRINCIPAL_INVESTIGATOR

Clinique Psychiatrique Universitaire CPU / CHRU de Tours

Lyna CHAMI, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Régional du Psychotraumatisme CRP / CHRU TOURS

François KAZOUR, MD, PhD, Professor

Role: PRINCIPAL_INVESTIGATOR

Psychiatrie / CHU ANGERS

Arnaud LEROY, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre régional du Psychotraumatisme des Hauts de France / CHU LILLE

Matthieu FRAIGNEAU, MD

Role: PRINCIPAL_INVESTIGATOR

Urgences psychiatrique / CHU MONTPELLIER

Anne SAUVAGET, MD, PhD, Professor

Role: PRINCIPAL_INVESTIGATOR

Unité de neuromodulation en psychiatrie / CHU NANTES

Sophie LAPUJOULADE, MD

Role: PRINCIPAL_INVESTIGATOR

Centre départemental de Psychotraumatologie (unité TCC) / ORLEANS

Amaury MENGIN, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Régional du Psychotraumatisme du Grand Est / CHU STRASBOURG

Central Contacts

Alexis VANCAPPEL, PhD

Role: CONTACT

alexis.vancappel@univ-tours.fr

02.34.37.89.47

Bachir Ahmed MKADARA, Master's

Role: CONTACT

ba.mkadara@chu-tours.fr

02.47.47.46.38

Other Identifiers

DR240330

Identifier Type: -

Identifier Source: org_study_id