NCT07342270

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
32mo left

Started Feb 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Feb 2026Dec 2028

First Submitted

Initial submission to the registry

December 18, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

January 15, 2026

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

December 18, 2025

Last Update Submit

January 7, 2026

Conditions

Keywords

Sensorimotor PsychotherapyPersonality disordersEarly childhood traumaSP-protocol

Outcome Measures

Primary Outcomes (1)

  • Emotion regulation-Difficulties in Emotion Regulation Scale

    The Difficulties in Emotion Regulation Scale (DERS) is used to assess the primary parameter, emotion regulation (Kaufman et al., 2016). This is a 36 item self-report questionnaire for evaluating emotion regulation problems. The factors correspond to the six factors from the scale. The scales are: 1. not accepting emotional responses, 2. difficulties in showing goal-directed behavior, 3. problems with impulse control, 4. lack of emotional awareness, 5. limited access to emotion regulation strategies, and 6. lack of emotional clarity. The questionnaire has excellent validity and reliability (Cronbach's alpha = 0.89) (Kaufman et al., 2016). A higher score indicates more problems in emotion regulation.

    A pre-intervention, post-intervention and follow-up (8-weeks post-intervention).

Secondary Outcomes (4)

  • Body awareness- Multidimensional Assessment of Interoceptive Awareness

    A pre-intervention, post-intervention and follow-up (8-weeks post-intervention).

  • Self-soothing-Soothing Receptivity Scale

    A pre-intervention, post-intervention and follow-up (8-weeks post-intervention).

  • PTSD-symptoms - PTSD-checklist for DSM-5

    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

    A pre-intervention, post-intervention and follow-up (8-weeks post-intervention).

Study Arms (2)

Treatment as usual

ACTIVE COMPARATOR

Treatment as usual for personality disoders

Other: Treatment as ususal

Sensorimotor Psychotherapy

EXPERIMENTAL

Sensorimotor Psychotherapy 12-session group protocol

Other: Sensorimotor Psychotherapy

Interventions

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.

Sensorimotor Psychotherapy

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.

Treatment as usual

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Personality Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2025

First Posted

January 15, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

January 15, 2026

Record last verified: 2025-09