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Not yet recruiting NCT07342270

Sensorimotor Psychotherapy for Personality Disorders

No phase Interventional Early Chilhood Trauma Personality Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sensorimotor Psychotherapy, Treatment as ususal.
Who it may be relevant to
Registry conditions: Early Chilhood Trauma, Personality Disorder. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

SUMMARY Rationale: Personality disorders are treated conform the Dutch GGZ-zorgstandaard mainly with verbal psychotherapies but experts by experience call out to make use of body-oriented approaches as well. In general, the rationale to study the effects of bodily centered therapy for personality disorders is built on the overlap between personality disorders and posttraumatic stress disorder (PTSD). In both classifications, childhood major events and/or traumatic life events play a role in the history of its origins (Karatzias et al., 2023).Traditional psychotherapies for personality disorders address the cognitive and emotional elements of trauma, but lack techniques that work directly with the physiological elements, although trauma profoundly affects the body and many symptoms of traumatized individuals with personality disorders are somatically based. However, studies into the effect of body centered interventions for personality disorders are scarce. This study aims to examine the effects of sensorimotor psychotherapy (SP), a body-oriented intervention, in patients with a personality disorder and PTSD-symptoms. This study studies the effect of sensorimotor psychotherapy (SP) which is a body-oriented intervention which focuses on the combination of a personality disorder and post-traumatic stress disorder. Objective: This multi-center randomized controlled study aims to research the effect of a 12-session sensorimotor psychotherapy (SP) group intervention, in comparison with treatment-as-usual, on emotion regulation in people with a personality disorder. In addition, the effects on body awareness, self-soothing, PTSD-symptoms and personality functioning are assessed. Patients' perception of the intervention will be assessed through qualitative techniques. The study will be carried out in five mental health institutions in the Netherlands. Study design: This is a multi-center randomized controlled trial, in which the intervention group receives a 12-sessions SP-therapy, and the control group receives treatment-as-usual of the assigned institution. Measurements through standardized instruments take place at three moments: pre-intervention (T0), post-intervention (T1), and two months follow-up (T2). Qualitative interviews are conducted after completion of the SP-condition. In combination with the qualitative measurements, a Mixed Methods Design is used. Study population: Patients older than 18 years, who have been diagnosed with a personality disorder and have experienced early childhood trauma. Intervention: patients assigned to the SP-condition receive the 12-session SP group protocol (Fisher \& Ogden, 2016), this protocol introduces diverse successive skills, aiming for the patient to have more somatic resources to regulate arousal of the autonomous nervous system. Every session starts with psychoeducation on a trauma-related theme, followed by one or multiple skills which are practiced in dyads and are later discussed in the group. The subjects which are covered are: autonomous arousal, implicit memory, regulation techniques, survival sources, somatic and internal resources, boundaries, practicing with experiments and repetitions, focus on positive change. Main study parameter: The main parameter of this study is emotion regulation. Emotion regulation is examined with the Difficulties in Emotion Regulation Scale - Short Form (DERS-SF). Secondary parameters: Second parameters are body awareness, self-soothing, PTSD-symptoms, personality functioning. Body awareness is examined with the Multidimensional Assessment of Interoceptive Awareness (MAIA-2). The Soothing Receptivity Scale (SRS) is used to examine self-soothing abilities. The PTSD-checklist for DSM-5 (PCL-5) is used to assess the PTSD-symptoms. The Level of Personality Functioning Scale-Brief Form 2.0 (LPFS-BF 2.0) is used to map out personality functioning. The patients' perception of the intervention is explored through qualitative interviews. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients involved in this study are indicated for treatment for a personality disorder. Sensorimotor psychotherapy belongs the treatment options of some mental health institutions. Additionally, patients who are assigned to the control condition are offered the SP-condition after completing the control condition. In this way they can also benefit from the SP-condition. Questionnaires are filled in at three moments during the treatment (T0, T1, T2), filling in the questionnaires will take 60 minutes on average, which is little more than routine outcome measurement takes in Dutch mental healthcare. The qualitative interviews after the SP-condition will take up 60 minutes on average.

Interventions

  • Other Sensorimotor Psychotherapy
    Sensorimotor psychotherapy (SP) is a body-oriented approach for people with personality disorders. The SP-intervention consists of 12-session SP-protocol which is applied in a groupsetting. Each session starts with psycho-education on a trauma-related topic, followed by one or multiple skills which are practized and discussed within the group.
  • Other Treatment as ususal
    The control condition consists of the standard treatment for personality disorders as provided within the mental health care institution. This treatment may comprise various components, depending on the specific institution. The nature and extent of the treatment provided will be documented.

Primary outcome measures

  • Emotion regulation-Difficulties in Emotion Regulation Scale [Time frame: A pre-intervention, post-intervention and follow-up (8-weeks post-intervention).]
Secondary outcome measures (4)
  • Body awareness- Multidimensional Assessment of Interoceptive Awareness [Time frame: A pre-intervention, post-intervention and follow-up (8-weeks post-intervention).]
  • Self-soothing-Soothing Receptivity Scale [Time frame: A pre-intervention, post-intervention and follow-up (8-weeks post-intervention).]
  • PTSD-symptoms - PTSD-checklist for DSM-5 [Time frame: A pre-intervention, post-intervention and follow-up (8-weeks post-intervention).]
  • Level of Personality functioning - Level of Personality Functioning Scale-Brief Form 2.0 [Time frame: A pre-intervention, post-intervention and follow-up (8-weeks post-intervention).]

Eligibility criteria

Inclusion criteria

  • Aged 16 and older
  • Diagnosed with a personality disorder according to the DSM-classification
  • Has a history of early childhood trauma

Exclusion criteria

  • Does not master Dutch / English sufficiently for filling out the questionnaire cannot fill participate in the research.
  • Presents factors or behaviour that disrupts participation in the group and undermines treatment will be excluded from this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07342270 · TSB_RP2165 · NL-009734

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗