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NCT06983002
Bridging Affect Consciousness, Mentalization and Trauma- Exploring an Integrative Treatment Approach for Personality Disorder (PD).
NA trial testing Experimental group: AC-group therapy intervention. in Personality Disorder, Borderline in 300 participants. Not yet recruiting.
19 May 2029
Quick facts
| Lead sponsor | Helse Stavanger HF |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 300 |
| Start date | 19 May 2025 |
| Primary completion | 19 May 2029 |
| Estimated completion | 19 April 2035 |
| Sites | 1 location across Norway |
Drugs / interventions tested
- Experimental group: AC-group therapy intervention.
- Control group 1: Body Awareness Group.
- Control group 2: Art Psychotherapy group.
Conditions studied
- Personality Disorder, Borderline — all drugs for Personality Disorder, Borderline →
- Personality Trait — all drugs for Personality Trait →
- Personality Disorder — all drugs for Personality Disorder →
- Personality Type — all drugs for Personality Type →
Sponsor
Helse Stavanger HF — full company profile →
Who can join
Adults 20 to 40, any sex, with Personality Disorder, Borderline or Personality Trait. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Study background: Specialized Group Outpatient Clinic within specialist mental health services, tailoring two year group treatment programmes for severe Avoidant PD (AvPD) and Borderline PD (BPD) with Affect Consciousness (AC) targeting specific areas of emotional dysfunction. Aims: Our main hypothesis, adding AC to Mentalization- based treatment (MBT) to expand the breadth and depth of therapeutically productive work on affect, will aim to examine health indicators, processes and mechanisms of change in depth. The study will extracts preliminary data after 5 years and 10 years to investigate clinical change, variation and outcome during MBT for PD employing AC as add on to MBT. The study has a randomized controlled trail design, with MBT with or without AC as add-on. The RCT is grounded on original literature on Affect Theory, as a framework for understanding patient functioning, and MBT, framing the therapy.Implications: AC methodology as add on can lead to more tailored treatment programmes, service planning, allocation of resources, guidelines, ACI certification and method development for PDs.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06983002
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06983002 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Helse Stavanger HF
- Last refreshed: 21 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06983002.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing