|- candidate number||14593|
|- NTR Number||NTR3921|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-mrt-2013|
|- Secondary IDs||41303 METC|
|- Public Title||Group schematherapy versus group cognitive behavioral therapy for social anxiety disorder with comorbid avoidant personality disorder.|
|- Scientific Title||Group schematherapy versus group cognitive behavioral therapy for social anxiety disorder with comorbid avoidant personality disorder.|
|- hypothesis||Patients included in this trial will be diagnosed with both
social anxiety disorder and avoidant personality disorder.
Improvements can thus be realized on 2 different domains,
namely with respect to severity of social anxiety disorder and
with respect to avoidant personality disorder. Since no
previous studies have been conducted with this specific
patient group, there are no a priori hypotheses about
differences in treatment effectiveness.|
|- Healt Condition(s) or Problem(s) studied||Social Anxiety Disorder, Avoidant Personality Disorder|
|- Inclusion criteria||Patients aged between 18 and 65 with primary diagnoses of social anxiety disorder on axis I and comorbid avoidant personality disorder on axis-II (i.e. the principal focus of attention of treatment, according to both patient and clinical staff) will be included in the study. Other inclusion criteria are willingness, motivation and practical ability to attend 30 sessions of group therapy and to refrain from treatment or counseling outside the context of the present trial. The use of antidepressant medication or benzodiazepine will be permitted, under the condition that the medication dose has been stable for at least 3 months before inclusion and patients are willing not to change the dosage or change medication during the active phase of the trial. Furthermore, patients have to be willing to complete daily homework assignments between sessions and have to sign written informed consent to participate in the study.|
|- Exclusion criteria||Exclusion criteria will be a primary Axis-I diagnosis of substance abuse or dependence which needs detoxification (after successful detoxification patients can participate), suicidality, and the presence of psychotic or bipolar symptoms because these conditions could interfere with the measurement and treatment procedures and suggest an immediate need for alternative interventions. Other exclusion criteria are a primary Axis II diagnosis of a Borderline, antisocial, schizoid, schizotypal personality disorder (because they need highly specialized treatment) and IQ less than 80 and Problems with Dutch language (talking, reading, writing).|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2013|
|- planned closingdate||1-sep-2018|
|- Target number of participants||128|
|- Interventions||1. Group Schema Therapy (GST) is a recently developed treatment for personality disorders. GST is shorter, more directive, confrontative, and integrative (using experiential, cognitive, and behavioral techniques, addressing childhood and present) than traditional psychotherapies.
2. Group Cognitive Behavioral Therapy (GCBT)
will consist of cognitive and exposure elements proven effective in the treatment of social anxiety disorder.
Both therapies will be given in 30 sessions of 90 minutes.
|- Primary outcome||1. Mini-International Neuropsychiatric Interview (MINI) will be used to obtain DSM-IV diagnoses for inclusion;|
2. Structured Clinical Interview for DSM Axis II Disorders (SCID II) will be used to assess the presence versus absence of avoidant personality disorder and comorbid Axis II diagnoses;
3. The clinician-administered version of the Liebowitz Social Anxiety Scale (LSAS-CA) will be used to assess the range of anxiety in social interaction and performance in situations which patients with social anxiety disorder may fear.
|- Secondary outcome||1. Schemamode Inventory II (SMI-2);|
2. The self-report version of the Liebowitz Social Anxiety Scale (LSAS-SR);
3. Beck Depression Inventory-II (BDI-II);
4. World Health Organization Quality of Life – Bref (WHOQOL-Bref);
5. Difficulties in Emotion Regulation Scale (DERS); The Rosenberg Self-Esteem Scale;
6. The Interview for Traumatic Events in Childhood (ITEC).
|- Timepoints||1. M 1 - 3: Preparations;|
2. M 3 - 24: Screening (M0) and treatment;
3. M 9 – 29: Midtests (M1);
4. M 14 – 34: Posttests (M2);
5. M 20 - 40: 6- month follow-up 6 (M3);
6. M 26 - 46: 12- month follow-up (M4);
7. M 26 – 60: Analyses and publications.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. Anja Greeven|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Anja Greeven|
|- Sponsor/Initiator ||PSYQ Haaglanden|
(Source(s) of Monetary or Material Support)
|- Brief summary||Social phobia with comorbid avoidant personality disorder has a high prevalence and is associated with serious psychosocial problems and high societal costs. The current multidisciplinary guidelines advice to offer prolonged CBT in case of social anxiety disorder with avoidant personality disorder. There is increasing evidence for the effectiveness of group schema therapy (GST) for personality disorders. GST focuses on changing the underlying dysfunctional schemas and coping strategies. Until now, it is unknown whether GST for social phobia and comorbid avoidant personality disorder is more effective than CBT. |
|- Main changes (audit trail)||28-jun-2016: |
Exclusion criteria will be a Axis-I diagnosis of
substance abuse or dependence which needs, according to
the clinical staff, detoxification (after successful
detoxification patients can participate), suicidality, and the
presence of psychotic or bipolar symptoms because these
conditions could interfere with the measurement and
treatment procedures and suggest an immediate need for
alternative interventions. Other exclusion criteria are: a
primary Axis II diagnosis of a Borderline, antisocial,
schizoid, schizotypal personality disorder (because they
need highly specialized treatment), and IQ less than 80 (in
case of suspicion an intelligence test is taken), suspicion of
an autism spectrum disorder (based on the sum score on the
Autisme-Spectrum Quotient (AQ) higher than 32 )and
problems with Dutch language (talking, reading, writing).
Primary outcome NEW:
1. The self-report version of the Liebowitz Social Anxiety
Scale (LSAS-SR) will be used as primary outcome for social
anxiety disorder. The LSAS-SR assesses the range of anxiety
in social interaction and performance in situations which
patients with social anxiety disorder may fear.
2. The primary outcome measure for severity of avoidant
personality disorder is the clinician-administered Avoidant
Personality Disorder Severity Index (AVPDSI). The AVPDSI is
a semi-structured interview developed specifically for this
study to assess the frequency and severity of manifestations
of avoidant personality disorder, as defined in the DSM-IV/5,
during the last month.
Secondary outcome NEW:
1. Schema Mode Inventory II (SMI-2);
2. The social anxiety disorder section of the Mini
International Neuropsychiatric Interview (MINI).
3. The avoidant personality disorder section of the
Structured Clinical Interview for DSM Axis II Disorders (SCID
4. Inventory of depressive symptomatology self-report (IDS-
5. World Health Organization Quality of Life – Bref
6. Difficulties in Emotion Regulation Scale (DERS);
7. The Rosenberg Self-Esteem Scale (RSES);
8. Acceptance and Action Questionnaire (AAQ-II)
Measurements will be done at start (T0), halfway (T1) and at
the end (T2) of the treatment period and during follow up at
3 (T3), 6 (T4) and 12 months after study treatment (T5).
|- RECORD||25-mrt-2013 - 28-jun-2016|