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

Not Applicable

Not yet recruiting

• Conditions: Dissociative Disorder

• Registration Number: NCT06917209
• Lead Sponsor: University Hospital, Tours

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08
• Study Start: 2025-04-22
• Primary Completion: 2026-07-22
• Study Completion: 2027-04-22

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Difference in Dissociative Experience Scale (DES)	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.

Secondary Outcome Measures

Name	Time	Method
Hetero-administered visual analogue scale	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.
Dissociative Experiences Scale (DES)	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.
Hospital Anxiety Depression Scale (HADS)	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).
Dissociation Questionnaire (DIS-Q)	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.
Post traumatic stress disorder checklist scale (PCL-5)	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.
Satisfaction With Life Scale (SWLS)	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.