|- candidate number||12929|
|- NTR Number||NTR3513|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-jun-2012|
|- Secondary IDs||2011/98 METc VUmc|
|- Public Title||Effectiveness of Autonomy-Groups in Patients with Anxiety Disorders: A RCT.|
Effectiviteit van Autonomiegroepen in PatiŽnten met Angststoornissen: Een RCT.
|- Scientific Title||Effectiveness of Autonomy-Groups in Patients with Anxiety Disorders: A RCT.|
|- hypothesis||1. Patients with anxiety disorders show an increase of autonomy after the Autonomy-Group treatment;|
2. Patients with anxiety disorders show a decrease of their symptoms after the Autonomy-Group treatment.
|- Healt Condition(s) or Problem(s) studied||Anxiety, Anxiety disorders|
|- Inclusion criteria||1. > 18 years old;|
2. Diagnosis of one or more anxiety disorders according to DSM IV TR. Main diagnosis has to be an anxiety disorder.
|- Exclusion criteria||Having a main diagnosis of obsessive compulsive disorder or post traumatic stress disorder, psychosis, addiction, suicidal thoughts or attempts, acute mourning or crisis or mental retardation.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2012|
|- planned closingdate||1-sep-2014|
|- Target number of participants||76|
|- Interventions||Intervention, Autonomy Group: |
The treatment is aimed at increasing autonomy by means of a protocol developed for this study. There are 15 sessions of AGs each offered once in a week, taking 2 to 2,5 hours. Every group has an average of 8 to 10 patients.
The control group consists of patients on a waiting list. The duration of the waiting list is the same as that of the intervention group: 15 weeks.
|- Primary outcome||1. The three subscales of the Autonomy-Connectedness Scale 30 (ACS-30);|
2. The total score on the Symptom Checklist 90 (SCL-90).
|- Secondary outcome||1. Subscales of the Symptom Checklist 90 (SCL 90);|
2. Anxiety: Fear Questionnaire (FQ);
3. Depression: Beck Depression Inventory-II (BDI-II);
4. Eating Disorder: Eating Disorder Examination-questionnaire (EDE-Q);
5. Quality of life: WHO Quality of Life - BREF (WHOQOL-BREF);
6. Self esteem: Rosenberg Self-Esteem Scale (RSE).
|- Timepoints||Before treatment (T1), halfway (7 weeks, T2) and after treatment (15 weeks, T3).|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. E.A.P. Rutten|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. M.H.J. Bekker|
|- Sponsor/Initiator ||Tilburg University, GGZ inGeest, VU University Medical Center|
(Source(s) of Monetary or Material Support)
|- Brief summary||The aim of this study is to examine the effect of autonomy-groups in patients with anxiety disorders. This study uses a Randomized Controlled Trial (RCT) design. There will be two groups of patients with anxiety disorders, the AGs and the control-groups (waiting list) and three measurement moments: before, halfway, and at the end of treatment. Participants fill out several questionnaires concerning autonomy-connectedness and mental health.
Patients will be recruited in the Netherlands.
|- Main changes (audit trail)|
|- RECORD||22-jun-2012 - 26-jul-2012|