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NCT Number: NCT06917209

Evaluation of the Efficacy of Dissociation-Focused Cognitive Behavior Therapy

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.

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Key information

Conditions

Dissociative Disorder Dissociative Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychiatrie / CHU ANGERS, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT-CD psychotherapy

Other

9 weekly sessions of CBT-CD psychotherapy

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexis VANCAPPEL, PhD

CONTACT

[email protected]

02.34.37.89.47

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

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

Acronym: TCC-DISSO

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Apr 8, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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