Effectiveness of PTSD-treatment Compared to Integrated PTSD-PD-treatment in Adult Patients With Comorbid PTSD and CPD

NCT03833531 | Completed

• 1 other identifier: PROSPER2018-C
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of PROSPER-C is to study effectiveness of ImRs compared to integrated SFT-ImRs in treatment-seeking, adult patients with comorbid PTSD and Cluster C Personality Disorder (CPD).

Conditions

Posttraumatic Stress Disorder (PTSD); Avoidant Personality Disorder; Dependent Personality Disorder; Obsessive Compulsive Personality Disorder

Keywords

PTSD; CPD; Imagination and rescripting therapy (ImRs); Schema-Focused Therapy (SFT); Integrated treatment; Prediction

Outcome Measures

Primary Outcomes (1)

• CAPS-5 (Clinician Administered PTSD Scale)

  The CAPS-5 is a structured diagnostic interview to assess the frequency and severity of DSM-5 PTSD symptoms. The interview consists of 30 items, with higher scores indicating more severe symptomatology. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Similarly, CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20). A symptom cluster score may also be calculated for dissociation by summing items 19 and 20. To meet the criteria for PTSD diagnoses, at least one Criterion B and one Criterion C symptom, and two criterion D and E symptoms are required. Furthermore, Criterion F and G should be met.

  12 months

Secondary Outcomes (13)

• SCID-5-PD (Structured Interview for DSM-5 Personality Disorders)

  12 months

• PCL-5 (PTSD Checklist for DSM-5)

  12 months

• OQ-45 (Outcome Questionnaire-45)

  12 months

• BDI (Beck depression inventory)

  12 months

• AUDIT (Alcohol Use Disorders Identification Test)

  12 months

Study Arms (2)

PTSD-ImRS

ACTIVE COMPARATOR

PTSD treatment

Behavioral: ImRS

Integrated SFT-ImRS

EXPERIMENTAL

Integrated PTSD-PD treatment

Behavioral: ImRS; Behavioral: SFT

Interventions

ImRS BEHAVIORAL

ImRs is a PTSD treatment that specifically addresses the troubling memories of the traumatic event and the personal meaning of the event and consist of 12 to 18 sessions in maximum 6 months.

Integrated SFT-ImRS; PTSD-ImRS

SFT BEHAVIORAL

SFT is a treatment for personality disorders that takes at least one group-session per week, for the duration of one year.

Integrated SFT-ImRS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with PTSD (309.81), and
• Diagnosed with a cluster C personality disorder (avoidant 301.82, dependent 301.6, and/or obsessive-compulsive PD 301.4), or at least resp. 3, 4, and/ or 3 criteria of these PDs.
• To be eligible for the study, both patients and healthy controls (for the MRI scans) have to:
• Be aged between 18 and 65 years
• Give written informed consent
• Speak / understand Dutch sufficiently

You may not qualify if:

• Current psychosis
• Comorbidity interfering with treatment or randomisation (severe outward aggression, antisocial PD, treatment interfering addiction or eating disorders, somatic problems)
• Primary diagnosis of paranoid, schizoid, schizotypal, narcissistic, histrionic or antisocial PD
• Mental retardation
• Pregnancy
• Metal implants (such as pacemakers, etc.);
• Somatic disorders interfering with brain functioning
• Claustrophobia
• High dose use of benzodiazepines

Sponsors & Collaborators

• Arkin: lead
• Sinai Centrum, Arkin, The Netherlands: collaborator
• Amsterdam UMC, location VUmc: collaborator
• Stichting Steunfonds Joodse Geestelijke Gezondheidszorg (SSF JGG): collaborator
• Ziekenhuis Amstelland: collaborator
• Meander Medisch Centrum: collaborator

Study Sites (1)

Sinai Centrum

Amstelveen, North Holland, 1180EB, Netherlands

Location

Related Publications (24)

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• van den End A, Beekman ATF, Dekker J, Aarts I, Snoek A, Blankers M, Vriend C, van den Heuvel OA, Thomaes K. Trauma-focused and personality disorder treatment for posttraumatic stress disorder and comorbid cluster C personality disorder: a randomized clinical trial. Eur J Psychotraumatol. 2024;15(1):2382652. doi: 10.1080/20008066.2024.2382652. Epub 2024 Aug 1.

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• Aarts I, Vriend C, Snoek A, van den End A, Blankers M, Beekman ATF, Dekker J, van den Heuvel OA, Thomaes K. Neural correlates of treatment effect and prediction of treatment outcome in patients with PTSD and comorbid personality disorder: study design. Borderline Personal Disord Emot Dysregul. 2021 May 5;8(1):13. doi: 10.1186/s40479-021-00156-8.

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• van den End A, Dekker J, Beekman ATF, Aarts I, Snoek A, Blankers M, Vriend C, van den Heuvel OA, Thomaes K. Clinical Efficacy and Cost-Effectiveness of Imagery Rescripting Only Compared to Imagery Rescripting and Schema Therapy in Adult Patients With PTSD and Comorbid Cluster C Personality Disorder: Study Design of a Randomized Controlled Trial. Front Psychiatry. 2021 Mar 19;12:633614. doi: 10.3389/fpsyt.2021.633614. eCollection 2021.

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MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Personality Disorders; Dependent Personality Disorder; Compulsive Personality Disorder

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Kathleen Thomaes, MD/PhD

  Sinai Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessments will be performed by allocation-blind assessors. Upon seeing a participant for an assessment, assessors are instructed to immediately state that participants are not allowed to discuss aspects of the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized controlled trial comparing PTSD-treatment ImRs) to integrated PTSD-PD treatment (SFT-ImRS)in patients with PTSD and comorbid CPD. The PTSD treatment (ImRS) specifically address the troubling memories of the traumatic event and the personal meaning of the event and consist of 12 to 18 sessions in maximum 6 months. Integrated PTSD-PD treatment consist of a PTSD treatment (ImRS) interwoven in a PD treatment (SFT) that takes at least one group-session per week, for the duration of one year.

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: February 7, 2019
• Study Start: June 1, 2018
• Primary Completion: January 9, 2023
• Study Completion: May 5, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)