Cost-effectiveness of schema therapy for treatment-resistant anxiety disorders: A multicentre RCT
- Conditions
- anxietyanxiety disorders10002861
- Registration Number
- NL-OMON56961
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 172
- Age 18-65
- Primary diagnosis of an anxiety disorder (panic disorder, agoraphobia, social
anxiety disorder, generalised anxiety disorder, separation anxiety disorder and
specific phobia) according to DSM-5.
- Fulfilling criteria of treatment-resistance based on a systematic literature
search i) at least one unsuccessful cognitive behavioural therapy (CBT) trial
of >= 8 weeks; and ii) at least one unsuccessful pharmacological treatment with
a serotonergic antidepressant of >= 8 weeks OR valid reasons for not wanting to
or not being able to receive medication, and iii) moderate to severe anxiety
symptoms (Beck Anxiety Inventory score > 11). Adequacy of previous treatment
will be checked.
Substance use dependence
Acute suicidality
Received schema therapy in the past
Insufficient Dutch or English
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is the reduction in anxiety symptoms (difference over 36<br /><br>months), related to societal costs. For the cost-utility analysis, (mental<br /><br>health) quality of life, health care utilisation and productivity losses will<br /><br>be collected. The measurements will be conducted at baseline and 1, 3, 6, 12,<br /><br>24 and 36 months after baseline. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are remission from the primary anxiety disorder and from<br /><br>comorbid diagnoses (baseline, 12, 24 and 36 months), general mental health<br /><br>(baseline and 12, 24 and 36 months), schemas (baseline and 12 and 36 months),<br /><br>schema modes (baseline and 3, 6, 12 and 36 months), functioning and recovery<br /><br>(baseline and 12, 24 and 36 months), positieve and negative effects of<br /><br>psychotherapy (12 months) and satistfaction with treatment (12 months). </p><br>