Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06298695
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-02-29
Brief Title:
Schema Therapy for Treatment-resistant Anxiety Disorders
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
Cost-effectiveness of Schema Therapy for Treatment-resistant Anxiety Disorders A Multicentre RCT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PaDoLA
Brief Summary:
The aim of this study is to assess the cost-effectiveness of schema therapy compared to treatment as usual TAU in patients with treatment-resistant anxiety disorders In a multicenter randomized controlled trial patients will be assigned to receive individual schema therapy maximum of 40 sessions or treatment as usual control group within one year The primary outcome is the difference between ST and TAU conditions in anxiety symptoms as measured with the Beck Anxiety Inventroy BAI at post treatment Secondary outcomes include quality of life societal costs general mental health remission from the anxiety disorders andor comorbid affective disorders positive and negative effects of psychotherapy schemas and schema modes and satisfaction Measurements take place at baseline and after 1 3 6 12 24 and 36 months follow-up of two years
Detailed Description:
RATIONALE Although treatment for anxiety disorders is generally cost-effective a significant proportion of 30 to 60 of patients does not adequately respond to first-line treatments ie cognitive behavioral therapy CBT and antidepressants This patient group remains significantly impaired A next-step psychotherapy focusing on underlying vulnerability is urgently needed
OBJECTIVE To evaluate the cost-effectiveness of individual schema therapy max 40 sessions versus treatment as usual in patients with treatment-resistant anxiety disorders from a societal perspective
STUDY DESIGN Multicenter randomized controlled trial with a cost-effectiveness analysis and an embedded process evaluation The project title PaDoLA refers to PAtronen DOorbreken bij Langdurige Angst in Dutch which translates to breaking patterns in chronic anxiety
STUDY POPULATION Adults 18-65 years with treatment-resistant DSM-5 anxiety disorders recruited in specialized mental health care Treatment-resistance is defined as at least one failed trial of 8 weeks CBT plus one failed trial of a serotonergic antidepressant for 8 weeks plus persistence of anxiety symptoms
INTERVENTION Intervention group Individual schema therapy with max 40 sessions within one year Schema therapy is an integrative psychotherapy with a high emphasis on the therapeutic relationship limited reparenting use of trauma focused techniques experiential and cognitive techniques role-play and behavioral exercises The treatment protocol used in this study is adapted specifically for patients with treatment-resistant anxiety disorders
Control group Treatment as usual TAU described by the Dutch Quality Standard for Anxiety disorders As there is no gold standard psychotherapy for treatment-resistant anxiety disorders professionals often offer extended or intensified CBT andor pharmacological treatment in TAU The only restriction to TAU is that schema therapy may not be provided
MAIN STUDY PARAMETERSENDPOINTS
Primary outcome is the difference in anxiety symptoms as measured with the BAI at post treatment Primary outcomes for the cost-effectiveness analysis are anxiety symptoms quality of life and societal costs Measurements take place at baseline and after 1 3 6 12 24 and 36 months Secondary outcomes are general mental health remission from the anxiety disorders andor comorbid affective disorders positive and negative effects of psychotherapy schemas and schema modes and satisfaction Alongside the RCT a process evaluation is performed to gain insight in experiences of patients and provide suggestions for implementation
SAMPLE SIZEDATA ANALYSIS A total of 172 patients will be enrolled assuming a medium effect size d05 testing two-sided using at ɑ005 power 080 including adjustment for an anticipated 25 dropout We will perform an intention-to-treat analysis using a linear mixed model
COST-EFFECTIVENESS ANALYSIS A cost-effectiveness and cost-utility analysis will be performed to compare effects on anxiety symptoms quality of life and costs from a societal perspective including health care costs and productivity costs
TIME SCHEDULE Study duration is 7 years the first four years preparations will be made patients will be included and treated The follow-up phase of 2 years is necessary because effects are expected to be most prominent in the long term Implementation efforts will be continuous during the study period
OBJECTIVE To evaluate the cost-effectiveness of individual schema therapy max 40 sessions versus treatment as usual in patients with treatment-resistant anxiety disorders from a societal perspective
STUDY DESIGN Multicenter randomized controlled trial with a cost-effectiveness analysis and an embedded process evaluation The project title PaDoLA refers to PAtronen DOorbreken bij Langdurige Angst in Dutch which translates to breaking patterns in chronic anxiety
STUDY POPULATION Adults 18-65 years with treatment-resistant DSM-5 anxiety disorders recruited in specialized mental health care Treatment-resistance is defined as at least one failed trial of 8 weeks CBT plus one failed trial of a serotonergic antidepressant for 8 weeks plus persistence of anxiety symptoms
INTERVENTION Intervention group Individual schema therapy with max 40 sessions within one year Schema therapy is an integrative psychotherapy with a high emphasis on the therapeutic relationship limited reparenting use of trauma focused techniques experiential and cognitive techniques role-play and behavioral exercises The treatment protocol used in this study is adapted specifically for patients with treatment-resistant anxiety disorders
Control group Treatment as usual TAU described by the Dutch Quality Standard for Anxiety disorders As there is no gold standard psychotherapy for treatment-resistant anxiety disorders professionals often offer extended or intensified CBT andor pharmacological treatment in TAU The only restriction to TAU is that schema therapy may not be provided
MAIN STUDY PARAMETERSENDPOINTS
Primary outcome is the difference in anxiety symptoms as measured with the BAI at post treatment Primary outcomes for the cost-effectiveness analysis are anxiety symptoms quality of life and societal costs Measurements take place at baseline and after 1 3 6 12 24 and 36 months Secondary outcomes are general mental health remission from the anxiety disorders andor comorbid affective disorders positive and negative effects of psychotherapy schemas and schema modes and satisfaction Alongside the RCT a process evaluation is performed to gain insight in experiences of patients and provide suggestions for implementation
SAMPLE SIZEDATA ANALYSIS A total of 172 patients will be enrolled assuming a medium effect size d05 testing two-sided using at ɑ005 power 080 including adjustment for an anticipated 25 dropout We will perform an intention-to-treat analysis using a linear mixed model
COST-EFFECTIVENESS ANALYSIS A cost-effectiveness and cost-utility analysis will be performed to compare effects on anxiety symptoms quality of life and costs from a societal perspective including health care costs and productivity costs
TIME SCHEDULE Study duration is 7 years the first four years preparations will be made patients will be included and treated The follow-up phase of 2 years is necessary because effects are expected to be most prominent in the long term Implementation efforts will be continuous during the study period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10390022210010 | OTHER_GRANT | ZonMw | None |