|- candidate number||28143|
|- NTR Number||NTR6838|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-nov-2017|
|- Secondary IDs||CME LUMC NL61366.058.17|
|- Public Title||Efficacy of visual art therapy on anxiety symptoms in adult women|
|- Scientific Title||Efficacy of 3 months visual art therapy on anxiety symptoms in adult women with an anxiety disorder|
|- Healt Condition(s) or Problem(s) studied||Anxiety disorders, Generalised anxietydisorder, Social phobia, Panic disorder, Agoraphobia|
|- Inclusion criteria||• Leeftijd: 18-65 jaar |
• Angstsymptomen: score op 4DKL: verhoogd op angst (>7) en/of verhoogd op distress (=10/>10)
• Diagnose: vast te stellen mbv MINI-plus diagnostisch interview (P074.02, P074.01)
|- Exclusion criteria||• alcoholmisbruik, drugsverslaving (vast te stellen mbv MINI-plus diagnostisch interview)|
• pacemaker (ivm vertekening fysiologische metingen) (vast te stellen dmv telefonische screening)
• scores 4DKL: angst =7/<7 en/of distress <10
• Diagnose: OCD, PTSS of alleen een specifieke fobie
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||3-apr-2017|
|- planned closingdate||31-jul-2018|
|- Target number of participants||62|
|- Interventions||visual art therapy; anthroposophic art therapy|
|- Primary outcome||anxiety symptoms
|- Secondary outcome||- quality of life|
- emotion regulation
- executive functioning
|- Timepoints||T0: before start therapy / start waiting time|
T1: after therapy / after waiting time (3 months)
T2: follow up after three months
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Annemarie Abbing|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Erik Baars|
|- Sponsor/Initiator ||Leiden University, Leiden University of Applied Sciences|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background: |
For anxiety disorders as GAD, social phobia and panic disorder, treatment results of standard care are less successful then for other anxiety disorders. Investigating the effectiveness of other types of therapies is needed. RCTs are important for establishing efficacy of interventions. For anthroposophic art therapy, no RCT has been executed. Treatment of anxiety in adults is one of the best practices of AAT, according to therapists. An important reason for organizing/conducting an efficacy study.
Method: a single-blind randomized controlled trial (RCT) with repeated measures will be performed for this intervention research.
Participants are recruited by social media and posters/flyers in the practices of general practitioners.
Women with a moderate to severe anxiety symptoms (scoring >7 for anxiety and >10 for distress on the 4DKL(2)), aged between 18-65 years, ability to fill in questionnaires on a computer and a written informed consent belong to the inclusion criteria. Patients are excluded if they are aged less than 18 years or older than 65 years, have psychosis or hallucinations, drug dependence, pacemaker, or receive eurythmic or rhythmical massage therapy during study period.
The following diagnoses will be included: generalized anxiety disorder, social phobia and panic disorder (with or without agoraphobia), established by a diagnostic interview (MINI-plus).
Patients without one of these diagnoses are excluded.
Prestratification and Randomisation
Enrolled participants are divided into four strata: whether or not using psychotropic drugs, and whether or not having moderate or severe depression symptoms (4DKL: depression >6), and subsequently assigned to treatment (AT) or control group (WL) by means of block randomization.
We aim at a treatment group (art therapy: AT) and a control group of 30 participants each. The control group is a waiting list group (WL) that will not be treated with AAT for three months. After three months, the control group receives the therapy, making the total treatment group size 60.
After randomization 30 AT patients will receive ten to twelve individual art therapy sessions of 45 to 60 minutes per session during three months. Treatment is provided by qualified and registered art therapists.
Primary outcome measure is anxiety level (LWASQ) and stressresponsivity (psycho-physiological protocol: ECG and skin conductance).
Secondary outcome measures are: quality of life (MANSA), emotion regulation (DERS) and executive functioning (BRIEF-A, ANT).
Measurements will be executed:
Month 0: T0, before the start of the therapy (AT), or before start of waiting list (WL)
Month 3: T1, after three months of therapy (AT), or after three months waiting time (WL)
Month 6: T2, three months after ending of the therapy (AT), or after three months of therapy (WL)
|- Main changes (audit trail)|
|- RECORD||5-nov-2017 - 10-dec-2017|