Bridging Affect Consciousness, Mentalization and Trauma- Exploring an Integrative Treatment Approach for Personality Disorder (PD).

NCT06983002 | Not Yet Recruiting

• 1 other identifier: RCT Personality Disorder STV25
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Personality Disorder, Borderline; Personality Trait; Personality Disorder; Personality Type; Personality Disorder, Avoidant; Affect Consciousness; Mentalization; Reflective Functioning; PTSD; PTSD - Post Traumatic Stress Disorder; PTSD and Trauma-related Symptoms

Keywords

Affect Integration; RCT; Affect Consciousness; MBT; AvPD; BPD; Trauma; Personality Disorder (PD); Personality functioning; Emotional dysfunction; Bodily Awareness; Art Therapy

Outcome Measures

Primary Outcomes (16)

• Changes in emotional dysfunction, ACI evaluation

  The Affect Consciousness Interview (ACI), scale 1-9. Higher scores indicate more integrated and conscious affective functioning, whereas lower scores suggest difficulties in affect regulation or alexithymic traits.

  At time of inclusion (baseline), and at 6, 12, 18, and 24 months

• Changes in emotional dysfunction, All self report

  Self-report questionnaire: Affect Integration Inventory (AII), rating 112 items on a 10-point Likert scale (0 = does not fit at all, 9 = fits perfectly), where lower scores indicate lower affect integration across specific emotions.

  At time of inclusion (baseline), and at 6, 12, 18, and 24 months

• Changes in emotional dysfunction, TAS-20 self report

  Self-report questionnaire: Toronto Alexithymia Scale (TAS-20), rating 20 items on a 5-point Likert scale (1 = strongly disagree, 7 = strongly agree), where total scores: ≥61 = high alexithymia, 52-60 = possible alexithymia, ≤51 = non-alexithymic

  At time of inclusion (baseline), and at 6, 12, 18, and 24 months

• Changes in emotional dysfunction, B-MAS self report

  Self-report questionnaire: Brief Mentalized Affectivity Scale (B-MAS), rating 12 items on a 5-point Likert scale (1 = strongly disagree, 7 = strongly agree), where lower scores reflect suggest difficulties in affective self- reflection and regulation.

  At time of inclusion (baseline), and at 6, 12, 18, and 24 months

• Changes in emotional dysfunction, DERS self report

  Self-report questionnaire: Difficulties in Emotion Regulation Scale (DERS), rating 36 items on a 5-point Likert scale (1 = almost never, 7 = almost always), where higher scores reflect higher level of problems with regulating emotions.

  At time of inclusion (baseline), and at 6, 12, 18, and 24 months

• Changes in personality functioning, LPFS-BF self-report

  Self-report questionnaire: Level of Personality Functioning Scale - Brief Form 2.0 (LPFS-BF 2.0), rating 12 items on a 4-point Likert scale (0 = not at all true, 3 = completely true), where higher scores indicates higher levels of personality dysfunction.

  At time of inclusion (baseline), and at 6, 12, 18, and 24 months

• Changes in personality functioning, SIPP-118 self-report

  Self-report questionnaire: Severity Indices of Personality Problems - 118 (SIPP-118), ratring 118 items in a 4-point Likert scale (1 = fully disagree, 4 = fully agree), where higher scores reflect better adaptive personality functioning.

  At time of inclusion (baseline), and at 6, 12, 18, and 24 months

• Changes in personality functioning, ECR self-report

  Self-report questionnaire: Experiences in Close Relationships Scale (ECR), rating 36 items on a 7-point Likert scale (1 = strongly disagree, 7 = strongly agree), where higher scores indicate higher levels of attachment-related anxiety and attachment-related avoidance.

  At time of inclusion (baseline), and at 6, 12, 18, and 24 months

• Changes in reflective functioning, RFQ-54 self report

  Self-report questionnaire: Reflective Functioning Questionnaire (RFQ-54), rating 54 items on a 7-point Likert scale (1 = completely disagree to 7 = completely agree), where higher scores indicate reduced reflective functioning.

  At time of inclusion (baseline), and at 6, 12, 18, and 24 months

• Role of attachment related trauma - AAI

  The Adult Attachment Interview (AAI) uses the AAI Scoring System related to: coherence of mind (scale 1-9), unresolved loss (scale 1-9), unresolved trauma (scale 1-9), idealization of parents (scale 1-9), anger and passivity (scale 1-9), derogation, fear, and lack of memory (scale 1-9), and classifies the individual into categories of: autonomous/secure, dismissing, preoccupied, or unresolved/disorganized. This is to determine the individual's state of mind regarding early attachment experiences and related trauma symptoms.

  At time of inclusion (baseline), and at 6, 12 18 and 24 months

• Changes in PTSD symptoms, PCL-5 self report

  Self-report questionnaire: Post-Traumatic Stress Disorder Checklist for DSM-5 (PCL-5), rating 20 items 5-point Likert scale (0 = not at all, 4 = extremely), , where higher scores indicate higher levels of PTSD symptoms and a score ≥31 suggests probable PTSD diagnosis.

  At time of inclusion (baseline), and at 6, 12, 18, and 24 months

• Changes in PTSD and C-PTSD symptoms, ITQ self report

  Self-report questionnaire: International Trauma Questionnaire (ITQ), rating 18 items on a 5-point Likert scale (0 = not at all, 4 = extremely), evaluating symptoms of Post Traumatic Stress Disorder (PTSD) and Complex PTSD (CPTSD) and whether the individual have these diagnoses.

  At time of inclusion (baseline) and at 24 months

• Traumatic childhood experience, CTQ self report

  Self-report questionnaire: Childhood Trauma Questionnaire - Short Form (CTQ-SF), rating 28 items on a 5-point Likert scale (1 = never true, 5 = very often true), determining levels of early childhood maltreatment of emotional abuse, physical abuse, sexual abuse, emotional neglect and pysical neglect. Higher scores indicate greater exposure to developmental trauma.

  At time of inclusion (baseline), and at 6, 12, 18, and 24 months

• Changes in subjective bodily experience and body image, SKO self report

  Self-report questionnaire: Questionnaire of Body Experience (SKO), rating 64 items on a 6-point Likert scale (1 = never, 6 = All the time), where higher scores in negative dimensions indicates higher levels of dissociation, body alienation and/or trauma-related disturbances.

  At time of inclusion (baseline), and at 6, 12, 18, and 24 months

• Changes in levels of anxiety, GAD-7 self report

  Self-report questionnaire: Generalized Anxiety Disorder-7 (GAD-7), rating 7 items on a 4-point Likert scale (0 = not at all, 3 = nearly every day), where higher scores indicate higer levels of anxiety. A decrease of ≥4 points is considered a clinically significant improvement.

  At time of inclusion (baseline) and at 24 months

• Changes in depression symptoms, PHQ-9 self report

  Self-report questionnaire: Patient Health Questionnaire-9 (PHQ-9), rating 9 items on a 4-point Likert scale (0-3), where higher scores indicates higher levels of depression symptoms. A reduction of ≥5 points is considered clinically significant.

  At time of inclusion (baseline) and at 24 months

Study Arms (3)

Experimental group: AC-group intervention as Add- on group to MBT group therapy

EXPERIMENTAL

The study's sample (N \>300 in the period 2025-2035) is randomised into a two-group comparative design, 50% with AvPD and 50% with BPD will participate in an Affect Consciousness (AC) group as a supplement to MBT, experiment group.

Behavioral: Experimental group: AC-group therapy intervention.

Control group 1: Body Awareness Group as Add on group to MBT group therapy

ACTIVE COMPARATOR

25% with AvPD and 25% with BPD will participate in an Body Awareness group as a supplement to MBT as a control group.

Behavioral: Control group 1: Body Awareness Group.

Control group 2: Art Psychotherapy group as ADD- on to MBT group therapy

ACTIVE COMPARATOR

25% with AvPD and 25% with BPD will participate in an Art Psychotherapy group as a supplement to MBT as a control group.

Behavioral: Control group 2: Art Psychotherapy group.

Interventions

Experimental group: AC-group therapy intervention. BEHAVIORAL

The aim is to increase Affect consciousness and Affect integration with 15 two hour group session interventions. Interview for 4 central affect categories to become familiar with the questions/techniques is used pre and post group. Group meeting 1 presents the AC affect theory, 13 affect categories and the group program related to each individual group meeting. Group meetings 2-14 lectures on the current affect category, bodily attentional signals and inner mood/mental content, exploration of impact, handling and the signal function of emotions and non-verbal body language and verbal descriptions related to the desire and ability to express oneself. Group meeting 15 is evaluation, clarification, repetition and closure of the group. "On arrival" focus on disturbances (internal and external) for each participant and performance of four body awareness exercises is used. Therapeutic writings and listening to a piece of music shared by the participants in rotation are methods i

Experimental group: AC-group intervention as Add- on group to MBT group therapy

Control group 1: Body Awareness Group. BEHAVIORAL

The aim is to connect with and become more confident about the body experiences, needs and feelings, to gain an increased understanding of oneself. The Group consists of 15 group sessions. Group meeting 1 Introduces Body Awareness Therapy, group structure and content and focus on experiences and expectations. The practice of slow, simple movements for the whole body in a standing position, introduction of The Autonomous Compass model, giving an opportunity to figure out where to place themselves in the compass in the moment, exercise stimulating the feet and a relaxation exercise. Group meetings 2-14 focuses on a topic as grounding, balance, breathe, play, posture due to habitual positions, body language and emotions, self-compassion and boundaries, explored through experience by using various physical exercises, sharing body experiences and psychoeducation. Session 15 contains summary, evaluation and repetition.Reflection on the previous session and sharing homework is included.

Control group 1: Body Awareness Group as Add on group to MBT group therapy

Control group 2: Art Psychotherapy group. BEHAVIORAL

The aim is to keep an open "non-directive" psychodynamic and analytical approach to explore, discover and feel ownership of creativity as a form of expression. The group consists of 15 group sessions, where session 1-4 is setting the framework by presenting art mediums to be used collectively, creating security, a sense of community and solidarity sharing common challenges. Each individual is free to choose the motive and form of expression, with a high level of sharing and learning. Creative experiences made together on the use of art materials to convey the inner world, become the starting point for further creative exploration on a individual level with their inner selves in a self-developing therapeutic process. Session 1: Introduction to projection and how to read oneself into an object by using figures and sandplay. Sessions 2 - 4: How one can transfer, animate, or create personal expressions using collage, acrylic painting and clay.Groups 5-15 allows freedom to choo

Control group 2: Art Psychotherapy group as ADD- on to MBT group therapy

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Helse Stavanger HF: lead
• Oslo University Hospital: collaborator
• University of Oslo: collaborator
• University College, London: collaborator
• University of Stavanger: collaborator
• Aalborg University: collaborator

Study Sites (1)

Stavanger University Hospital

Stavanger, Rogaland, 4011, Norway

Location

MeSH Terms

Conditions

Borderline Personality Disorder; Personality Disorders; Stress Disorders, Post-Traumatic; Combat Disorders; Wounds and Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Ole Andrè Solbakken, Scientific Director/prof/PhD

  Section of Clinical Psychology at the Department of Psychology (PSI), Institute of Affect Theory and Psychotherapy group (IATP)The University of Oslo (UIO). Norway..

  STUDY DIRECTOR

• Inge Joa, PI/Associate professor/PhD

  The Regional Network for Clinical Psychosis Research (Psyk Nett Vest), the Western Norway Regional Health Authority, Stavanger University Hospital (SUS).

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inge Joa, Principal Investigator PI/PhD

CONTACT

47- 91392373; inge.joa@sus.no

Ole Andrè Solbakken, Scientific Director/prof./PhD

CONTACT

47-91375496; o.a.solbakken@psykologi.uio.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The raters and staticians are blinded. Clinicians not involved in the experimental intervention for research purposes will be used.

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: May 19, 2025
• Primary Completion (Estimated): May 19, 2029
• Study Completion (Estimated): April 19, 2035
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

NO (1)