Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02518906
Other study ID # EAST
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date November 2020

Study information

Verified date April 2021
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Specialized treatment of personality disorders (PD) in youth has been neglected for a long time, because these disorders were not diagnosed before the age of 18. Since 2013 the age threshold has been dropped in the Diagnostic and Statistical Manual (DSM)-5, and such change is also announced for the International Classification of Diseases (ICD)-11. There is broad consensus from both scientific evidence and clinical experience that specialized early interventions in adolescents with PD are urgently needed. In the last decades a number of specialized psychotherapeutic treatment programs have been developed. Despite their conceptual differences, many of the treatment models have shown significant effects in the treatment of PD in adults. However, the treatment of adolescents with PD remains difficult and further enhancement and development of treatments is needed. Given the different therapeutic approaches available, the present project aims to go beyond the comparison of integral therapeutic models in the classical outcome study design. While outcome research is important to build on the evidence of the effectiveness of an intervention, it contributes little to its understanding and refinement. The aim of the present multi-center project is to compare two therapeutic methods used in routine care: - Adolescent Identity Treatment (AIT) - Dialectic Behavioral Treatment for Adolescents (DBT-A) Treatments will be performed at different study centers and compared using the same measures of outcome. The main outcome will be psychosocial functioning. Additionally, the psychotherapy process will be investigated to explore specific and unspecific mechanisms of the therapeutic process, its outcome and mediators.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date November 2020
Est. primary completion date September 2019
Accepts healthy volunteers No
Gender All
Age group 13 Years to 19 Years
Eligibility Inclusion Criteria: - Identity Diffusion (AIDA T-score > 60) - borderline Criteria (SKID-II) Exclusion Criteria: - intelligence quotient (IQ) < 80 - psychotic disorder - pervasive developmental disorders - heavy and persistent substance abuse - major somatic or neurological disease - hospital treatment

Study Design


Intervention

Behavioral:
Adolescent Identity Treatment
Integrative Approach for the treatment of adolescents with Personality Disorder. Manual was published in 2013.
DBT-A
Dialectic Behavioral Treatment for Adolescents is the most commonly used Approach for the Treatment of adolescents with Boderline Personality Disorder

Locations

Country Name City State
Chile Millennium Institute for Research in Depression and Personality - Pontificia Universidad Católica de Chile Santiago de Chile
Germany Department of Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University of Heidelberg Heidelberg
Switzerland Psychiatric Universitiy Hospital Basel Basel

Sponsors (3)

Lead Sponsor Collaborator
Klaus Schmeck Heidelberg University, Pontificia Universidad Catolica de Chile

Countries where clinical trial is conducted

Chile,  Germany,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Children's Global Assessment Scale (CGAS) Psychosocial functioning. Rated considering the results of the Columbia Impairment Scale - parent and patient versions Baseline, 12 months after Baseline
Secondary Psychosocial functioning Columbia Impairment Scale (CIS) (Patient and Parent versions) Baseline, 12 months after Baseline
Secondary School functioning School Functioning Rating (SFR) Baseline, 12 months after Baseline
Secondary Change in Psychopathology Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) Baseline, 12 months after Baseline (only Basel and Heidelberg)
Secondary Change in Severity of Psychopathology Clinical Global Impression Scale Baseline, 12 months after Baseline
Secondary Change in Depression Beck Depression Inventory (BDI) Baseline, 12 months after Baseline
Secondary Change in Psychopathological Symptoms Strengths & Difficulties Questionnaires (SDQ) Baseline, 12 months after Baseline
Secondary Change in Personality Functioning Levels of Personality Functioning - Questionnaire for Adolescents (LoPF-QA) Baseline, 12 months after Baseline (only Basel and Heidelberg)
Secondary Change in Identity Assessment of Identity Development in Adolescence (AIDA) Baseline, 12 months after Baseline
Secondary Change in Personality Disorder Symptoms Structured Clinical Interview of Diagnostic and Statistical Manual of Mental Disorders (DSM) (SCID)-II Baseline, 12 months after Baseline (only Basel and Heidelberg)
Secondary Change in Interpersonal Problems Inventory of Interpersonal Problems (IIP-64) Baseline, 12 months after Baseline (only Santiago)
Secondary Change in Mentalizing Capacity Movie for the Assessment of Social Cognition (MASC) Baseline, 12 months after Baseline
Secondary Change in Quality of Life Health-related Quality of Life Screening Instrument for Children and Adolescents (KIDSCREEN) Baseline, 12 months after Baseline
Secondary Change in Parental Stress Eltern-Belastungs-Inventar (EBI) Baseline, 12 months after Baseline (only Basel and Heidelberg)
Secondary Self-injurious Behavior Self- Injurious Thoughts and Behaviors Interview Baseline, 12 months after Baseline (only Basel and Heidelberg)
Secondary Borderline-specific Personality Pathology Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Baseline, 12 months after Baseline (only Basel and Heidelberg)
Secondary Borderline-specific Symptoms Borderline Symptom List 23 (BSL-23) Baseline, 12 months after Baseline (only Basel and Santiago)
Secondary Change in Psychophysiological Measures (Only Basel and Heidelberg) Regression analysis will be used to evaluate change; Parameters: Heart Rate Variability and Electrodermal Activity (Basel only) Baseline, 12 months after Baseline
Secondary Change in Hair Cortisol Level (only Basel and Heidelberg) Baseline, 12 months after Baseline
See also
  Status Clinical Trial Phase
Recruiting NCT04856449 - DBT Skills Plus EMDR for BPD and Trauma N/A
Active, not recruiting NCT04587518 - Five Factor Model Treatment for Borderline Personality Disorder N/A
Recruiting NCT05651295 - A Precision Medicine Approach to Target Engagement for Emotion Regulation N/A
Completed NCT03677037 - The Short-Term MBT Project Phase 3
Not yet recruiting NCT05989529 - Delving Into Borderline Personality Disorder Clinical Trial Experiences
Completed NCT02068326 - MBT in Groups for Adolescents With BPD or Subthreshold BPD Versus TAU - the M-GAB Randomized Controlled Trial N/A
Recruiting NCT04296604 - Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations N/A
Completed NCT02108990 - Acetaminophen and Social Processes Phase 2
Terminated NCT02149823 - Examining Dose-Related Effects of Oxytocin on Social Cognition Across Populations Phase 1
Not yet recruiting NCT01683136 - Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device - Feasibility Study for the Treatment of Borderline Personality Disorder N/A
Completed NCT02988037 - Adapted Dialectical Behaviour Therapy for Adolescents With Deliberate Self-Harm: A Pre-post Observational Study N/A
Completed NCT01635556 - Evaluation of a Modified Dialectical Behavior Therapy Program N/A
Completed NCT02397031 - Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder N/A
Terminated NCT01103180 - Selective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder Phase 2
Terminated NCT01212588 - Preliminary Trial of the Effect of Glucocorticoid Receptor Antagonist on Borderline Personality Disorder (BPD) Phase 2
Terminated NCT00539188 - N-Acetylcysteine in Adjunct to DBT for the Treatment of Self-Injurious Behavior in BPD Phase 2
Recruiting NCT05398627 - Neurofeedback for Borderline Personality Disorder N/A
Recruiting NCT03994510 - SHame prOpensity in bOrderline Personality Disorder N/A
Recruiting NCT06005129 - Personality Change Study for Borderline Personality Disorder N/A
Recruiting NCT06406972 - Brief Admission by Self-referral for Individuals With Self-harm: Effects on Compulsory Care