Evaluation of the Efficacy of Dissociation-Focused Cognitive Behavior Therapy: a Multicenter Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University Hospital, Tours
- Enrollment
- 140
- Locations
- 8
- Primary Endpoint
- Difference in Dissociative Experience Scale (DES)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
The control group will receive 9 weekly relaxation sessions.
The experimental group will receive 9 weekly sessions of DF-CBT psychotherapy.
Intervention: CBT-CD psychotherapy (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Hetero-administered visual analogue scale(At randomization, 3 months and 6 months after)
- Dissociative Experiences Scale (DES)(At 6 months after randomization)
- Hospital Anxiety Depression Scale (HADS)(Randomization, 3 months and 6 months after)
- Dissociation Questionnaire (DIS-Q)(At randomisation, 3 months and 6 months after)
- Post traumatic stress disorder checklist scale (PCL-5)(Randomization, 3 months and 6 months after)
- Satisfaction With Life Scale (SWLS)(Randomization, 3 months and 6 months after)