RecruitingNot ApplicableNCT06367907

Biological Effects of Schema Therapy

Effects of Emotion-focused vs. Cognitive Schema Therapy Interventions on Emotion Regulation Deficits in Borderline Personality Disorder - Associations Between Clinical Efficacy, Brain Network Function and Local Glutamate/GABA Metabolism


Sponsor

Jena University Hospital

Enrollment

120 participants

Start Date

Sep 9, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Inclusion Criteria9

  • 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

Exclusion Criteria7

  • 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

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Interventions

OTHERschema therapy

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.


Locations(1)

University Hospital Jena

Jena, Germany

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NCT06367907


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