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Effectiveness of Autonomy-Groups in Patients with Anxiety Disorders: A RCT.
Effectiviteit van Autonomiegroepen in PatiŽnten met Angststoornissen: Een RCT.



- candidate number12929
- NTR NumberNTR3513
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-jun-2012
- Secondary IDs2011/98 METc VUmc
- Public TitleEffectiveness of Autonomy-Groups in Patients with Anxiety Disorders: A RCT.
Effectiviteit van Autonomiegroepen in PatiŽnten met Angststoornissen: Een RCT.
- Scientific TitleEffectiveness of Autonomy-Groups in Patients with Anxiety Disorders: A RCT.
- ACRONYM
- hypothesis1. 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) studiedAnxiety, Anxiety disorders
- Inclusion criteria1. > 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 criteriaHaving 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2012
- planned closingdate1-sep-2014
- Target number of participants76
- InterventionsIntervention, 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.

Control:
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 outcome1. The three subscales of the Autonomy-Connectedness Scale 30 (ACS-30);
2. The total score on the Symptom Checklist 90 (SCL-90).
- Secondary outcome1. 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).
- TimepointsBefore treatment (T1), halfway (7 weeks, T2) and after treatment (15 weeks, T3).
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. E.A.P. Rutten
- CONTACT for SCIENTIFIC QUERIESProf. Dr. M.H.J. Bekker
- Sponsor/Initiator Tilburg University, GGZ inGeest, VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VSB Fonds
- PublicationsN/A
- Brief summaryThe 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)
- RECORD22-jun-2012 - 26-jul-2012


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