Biological Effects of Schema Therapy

NCT06367907 | Recruiting

• 1 other identifier: SM 68/6-1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The major aim of this study is to compare the effects of emotion focused (experiential) and cognitive interventions of schema therapy (ST) on emotion regulation deficits in patients with borderline personality disorder (BPD) according to DSM-V (alternative model) criteria. In a randomized, single-blinded parallel-group design clinical effects as well as effects on neurotransmitter metabolism and connectivity will be compared. Method: While the 9-weeks treatment protocol of particular interest includes emotion focused interventions (ST-EF, n=60) such as chair dialogs, imagery rescripting or role play, the active control condition (ST-AC, n=60) is restricted to cognitive interventions, e.g. psychoeducation or pro/contra discussions. MEGA-PRESS 1H-MR spectroscopy and resting-state functional MR imaging (rs-fMRI) will be used before/after treatment protocols (T0-T1) and 6 months after the end of therapy (T2) to assess the effects on glutamate (Glx) and GABA metabolism in key regions of the target networks (executive control network, ECN: dorsolateral prefrontal cortex, DLPFC; salience network, SN: anteromedial cingulate cortex, aMCC; default mode network, DMN: pregenual cingulate cortex, pgACC) and to investigate the corresponding altered connectivity in these networks. The biological aberrations at T0 as compared to healthy controls (n=60) and treatment effects (at T1 and T2, n≥40 in each condition) on these aberrations will be linked to clinical effects measured by an extensive test battery with particular interest on emotion regulation, and specified by the Reliable Change Index (RCI). For longitudinal data mixed model analysis will be performed. The main questions are (1) whether the emotion regulation deficit and the pattern of BPD-specific symptomatology are associated with a specific pattern of Glx and GABA concentrations in the DLPFC, aMCC and pgACC and corresponding deviations of functional connectivity within the ECN, SN and DMN. Hypothesis: Depending on primary and secondary outcome measures at T0, altered RSFC in the DMN, SN and ECN and corresponding altered Glx or GABA concentrations are assumed. (2) whether both treatment conditions have different clinical effects on the ability to regulate emotions and whether the respective clinical effects are associated with the changes in neurobiological aberrations. Hypothesis: It is hypothesized that the ST-EF condition will improve emotion regulation skills more effectively than the control condition. Only in the ST-EF condition are higher response and remission rates expected in the primary and secondary outcome measures, as well as effects on the ECN, SN and DMN with corresponding changes in RSFC and Glx or GABA concentrations.

Conditions

Personality Disorders

Keywords

borderline personality disorder; emotion regulation; schema therapy; brain networks

Outcome Measures

Primary Outcomes (1)

• Changes in emotion regulation capabilities

  Being the core issue of this study, changes in emotion regulation capabilities are defined as primary outcome and will be assessed by the Emotion Regulation Inventory (ERI), which follows the Process Model of Emotion Regulation proposed by James Gross. Evaluation of changes in primary and secondary criteria and their clinical significance: In each therapeutic condition the improvement of each patient in measures of the primary and secondary outcome criteria will be estimated by the Reliable Change Index (RCI)(1)((2), which summarizes changes at the level of an individual in the context of observed changes for the whole sample. More detailed information on RCI scores and their meaning in each outcome measurement is given in the uploaded material.

  9 weeks (T1), 6 month after end of therapy (T2)

Secondary Outcomes (4)

• Improvement of BPD specific symptomatology

  9 weeks (T1), 6 month after end of therapy (T2)

• Change of personality traits

  9 weeks (T1), 6 month after end of therapy (T2)

• Changes of the intensity of early maladaptive schemas.

  9 weeks (T1), 6 month after end of therapy (T2)

• Changes of the intensity of schema modes.

  9 weeks (T1), 6 month after end of therapy (T2)

Study Arms (2)

ST-EF, schema therapy - emotion focused

EXPERIMENTAL

9-weeks treatment protocol based on emotion focused interventions, such as chair dialogs, imagery rescripting or role play

Other: schema therapy

ST-AC, schema therapy - active control

ACTIVE COMPARATOR

9-weeks treatment protocol based on cognitive interventions, e.g. psychoeducation, socratic dialog, pro/contra discussions etc. but no experiential techniques

Other: schema therapy

Interventions

schema therapy OTHER

In this study, we aim to investigate the mode of action of the core therapeutic techniques implemented in schema therapy (ST), a psychotherapy that particularly addresses deficits of emotion regulation and of social interaction in personality disorders.

ST-AC, schema therapy - active control; ST-EF, schema therapy - emotion focused

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are eligible if they
• fulfil diagnostic criteria (1.-4. see below) of BPD according to the Alternative DSM-5 Model (Sec-tion III of DSM 5, p 761ff (APA, 2013),
• are between 18 and 30 years of age,
• are female,
• are right-handed,
• are free of any treatment with antidepressants, antipsychotic or mood stabilizing medication (sporadic use of tranquillizers to induce sleep will be permitted)
• have never been in psychotherapy before (in particular DBT, ST, CBT, TBP),
• are willing to participate in (group) therapy,
• are willing to participate in the study

You may not qualify if:

• Patients will be excluded if they
• acutely suffer suicidal ideas,
• suffer manifest affective or anxiety disorder ac-cording to DSM-5 criteria or have a lifetime his-tory of or current psychotic disorder (except brief psychotic disorder according to the DSM-5),
• present a clinically manifest trauma-related dis-order (in particular PTSD),
• suffer dissociative identity disorder, substance dependence needing clinical detoxification, ano-rexia nervosa with BMI \< 14 or a serious and/or unstable medical illness,
• have an IQ below 80,
• are at any risk in terms of MRI investigations

Sponsors & Collaborators

• Jena University Hospital: lead

Study Sites (1)

University Hospital Jena

Jena, 07743, Germany

RECRUITING

Related Publications (1)

• Smesny S, Langbein K, Krylova M, Li M, Izyurov I, Gussew A, Gullmar D, Walter M, Wagner G, Reichenbach JR. Emotion-focused vs. cognitive interventions of schema therapy for borderline personality disorder: effects on neural emotion regulation networks - study protocol. Borderline Personal Disord Emot Dysregul. 2025 Nov 13;12(1):48. doi: 10.1186/s40479-025-00311-5.

  PMID: 41233856 DERIVED

MeSH Terms

Conditions

Personality Disorders; Borderline Personality Disorder; Emotional Regulation

Interventions

Schema Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Stefan Smesny

  Jena University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Smesny, PhD

CONTACT

+4936419390451; stefan.smesny@med.uni-jena.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Parallel-group: Both conditions (emotion focussed, ST-EF and active control, ST-AC) are highly standardized and active in terms of their expected clinical effect, which was a precondition for a positive ethics approval. Randomized: Patients are randomly assigned to the ST-EF or ST-AC condition according to a randomization list established by an independent statistician, and applied to incoming help-seeking patients by an independent admission management (managing nurse, not a member of the research team). Single-blinded: Researchers are blind as regards group belonging of participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. S. Smesny (MD, PhD)

Model Details: randomized, parallel-group, single-blinded

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: April 16, 2024
• Study Start: September 9, 2021
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

DE (1)