Evaluation of the Efficacy of Dissociation-Focused Cognitive Behavior Therapy (TCC-DISSO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dissociative Disorder
• Intervention / Treatment: Other: CBT-CD psychotherapy

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexis VANCAPPEL, PhD; Phone Number: 02.34.37.89.47; Email: alexis.vancappel@univ-tours.fr

Study Locations

• France
  • Angers, France
    • Not yet recruiting
    • Psychiatrie / CHU ANGERS
    • Contact: François KAZOUR, MD-PhD
    • Principal Investigator: François KAZOUR, MD-PhD
  • Lille, France
    • Not yet recruiting
    • Centre régional du Psychotraumatisme des Hauts de France / CHU LILLE
    • Contact: Arnaud LEROY, MD-PhD
    • Principal Investigator: Arnaud LEROY, MD-PhD
  • Montpellier, France
    • Not yet recruiting
    • Urgences psychiatrique / CHU MONTPELLIER
    • Contact: Matthieu FRAIGNEAU, MD
    • Principal Investigator: Matthieu FRAIGNEAU, MD
  • Nantes, France
    • Not yet recruiting
    • Unité de neuromodulation en psychiatrie / CHU NANTES
    • Contact: Anne SAUVAGET, MD-PhD
    • Principal Investigator: Anne SAUVAGET, MD--PhD
  • Orléans, France
    • Not yet recruiting
    • Centre départemental de Psychotraumatologie (unité TCC) / ORLEANS
    • Contact: Sophie LAPUJOULADE, MD
    • Principal Investigator: Sophie LAPUJOULADE, MD
  • Strasbourg, France
    • Not yet recruiting
    • Centre Régional du Psychotraumatisme du Grand Est / CHU STRASBOURG
    • Contact: Arnaury MENGIN, MD
    • Principal Investigator: Arnaury MENGIN, MD
  • Tours, France
    • Recruiting
    • Centre Régional du Psychotraumatisme CRP / CHRU TOURS
    • Contact: Lyna CHAMY, MD
    • Principal Investigator: Lyna CHAMY, MD
  • Tours, France
    • Recruiting
    • Clinique Psychiatrique Universitaire / CHRU de Tours
    • Contact: Wissam EL HAGE, MD-PhD
    • Principal Investigator: Wissam EL HAGE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The experimental group will receive 9 weekly sessions of DF-CBT psychotherapy.	Other: CBT-CD psychotherapy; 9 weekly sessions of CBT-CD psychotherapy
No Intervention: The control group will receive 9 weekly relaxation sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Dissociative Experience Scale (DES)	Difference in Dissociative Experience Scale (DES) between randomization and 3 months after. The DES assesses dissociation through 28 items. The total score ranges between 0 and 100, where high scores indicate high levels of dissociation.	Between randomization and 3 months after

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hetero-administered visual analogue scale	Visual analogue scales in which the practitioner rates the intensity of the patient's dissociative symptoms on the basis of his/her clinical assessment.	At randomization, 3 months and 6 months after
Dissociation Questionnaire (DIS-Q)	The Dissociation Questionnaire is a 63-item questionnaire measuring dissociative-trait manifestations. Participants respond to each item using a 5-point Likert scale. Four sub-scores (loss of control, absorption, amnesia and identity confusion) are calculated.	At randomisation, 3 months and 6 months after
Hospital Anxiety Depression Scale (HADS)	Hospital Anxiety Depression Scale (HADS) is a 14-item self-report questionnaire. Two sub-scores (anxiety and depression) are calculating. Both scores range between 0 and 21 with 0 corresponding to the ideal score (no anxiety or depression symptoms).	Randomization, 3 months and 6 months after
Post traumatic stress disorder checklist scale (PCL-5)	The post traumatic stress disorder checklist scale (PLC-5) is 20-item scale to assess post-traumatic stress symptoms. Participants respond to each item using a 5-point Likert scale. The score ranges between 0 and 80, with 0 reflecting no post traumatic stress disorder.	Randomization, 3 months and 6 months after
Satisfaction With Life Scale (SWLS)	The Satisfaction With Life Scale (SWLS) is a 5-item questionnaire assessing quality of life. Participants respond to each item using a 7-point Likert scale. The score range bewteen 0 and 35 with 35 reflects an extreme satisfaction with life.	Randomization, 3 months and 6 months after
Dissociative Experiences Scale (DES)	The DES assesses dissociation through 28 items. The total score ranges between 0 and 100, where high scores indicate high levels of dissociation.	At 6 months after randomization

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Study Chair: Alexis VANCAPPEL, PhD, Clinique Psychiatrique Universitaire / CHRU de Tours; Principal Investigator: Wissam EL HAGE, MD-PhD, Clinique Psychiatrique Universitaire CPU / CHRU de Tours

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2025
• Primary Completion (Estimated): August 22, 2026
• Study Completion (Estimated): May 22, 2027

Study Registration Dates

• First Submitted: April 1, 2025
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Dissociative Disorders
• Other Study ID Numbers: DR240330

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No