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

July 7, 2026 updated by: University Hospital, Tours

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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
        • Unité de Neuromodulation / CHU de Tours
        • Contact:
          • Wissam EL HAGE, MD-PhD
        • Principal Investigator:
          • Wissam EL HAGE, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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.
  • Pregnant women and breastfeeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: Between randomization and 3 months after

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
Time Frame: At randomization, 3 months and 6 months after
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)
Time Frame: At randomisation, 3 months and 6 months after
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)
Time Frame: Randomization, 3 months and 6 months after

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)
Time Frame: Randomization, 3 months and 6 months after
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)
Time Frame: Randomization, 3 months and 6 months after
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)
Time Frame: At 6 months after randomization
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

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Study Chair: Alexis VANCAPPEL, PhD, Unité de Neuromodulation / CHU de Tours
  • Principal Investigator: Wissam EL HAGE, MD-PhD, Unité de Neuromodulation / CHU de Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2025

Primary Completion (Estimated)

November 16, 2028

Study Completion (Estimated)

May 16, 2029

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)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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