Biological Effects of Schema Therapy - Trial NCT06367907

Timeline & Enrollment

Primary Outcome

Changes in emotion regulation capabilities

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.

ICD-10 Classifications