Standard treatments for anxiety disorders, such as cognitive behavioural therapy (CBT) and antidepressants, are generally effective. However, 30 to 60% of patients does not adequately respond to first-line treatments. This patient group remains significantly impaired, despite high health care use.
Major factors contributing to treatment-resistance are maladaptive “schemas”. These are core beliefs about oneself, others or the world – as well as dysfunctional personality traits. These schemas and personality traits prevent patients from actively engaging in exposure to feared situations, an otherwise highly effective treatment strategy. Schema Therapy (ST) for treatment-resistant anxiety disorders is specifically designed to address these underlying patterns while incorporating exposure.
Previous studies, including a recently concluded pilot study at GGZ inGeest, show that schema therapy is very promising for patients with treatment-resistant anxiety disorders. However, it remains unclear whether schema therapy is cost-effective, which patients benefit most, and how it can be effectively implemented in clinical practice.
Objective
In the PADOLA study, we evaluate the cost-effectiveness of individual schema therapy (up to 40 sessions) versus usual care for patients with treatment-resistant anxiety disorders. This multi-center randomised controlled trial includes an embedded process evaluation. As part of the process evaluation, we will conduct interviews to explore how patients, relatives, therapists and other stakeholders experience schema therapy. We will also identify barriers and facilitators for implementation and develop an practical implementation plan.
We will collect data at 1, 3, 6, 12, 24, and 36 months after baseline. Our main goal is to see whether anxiety symptoms decrease and how this relates to societal costs. We will be using the Beck Anxiety Inventory. We will also assess remission from primary anxiety disorders and comorbid disorders, general mental health, schemas, schema modes, functioning and recovery, the positive and negative effects of treatment, and satisfaction with treatment. In addition, we will explore whether treatment works differently for individuals depending on factors such as age, socio-economic status, sexual orientation, and comorbid disorders.
The following centers participate in this multi-center trial: GGZ inGeest (Amsterdam, Amstelveen, Haarlem, and Hoofddorp), Pro Persona (Nijmegen, Ede-Wageningen and Tiel), GGNet (Apeldoorn), Mondriaan (Maastricht and Heerlen) and GGZ Drenthe (Emmen and Assen). Additionally, we work closely together with experience experts in designing and conducting the study (the ADF Stichting).
The PADOLA study preparation began in 2024. Participant recruitment started in January 2025 and will continue until 2027, with the final participant completing study measurements in 2029. We expect to finish the data collection and analysis in 2030, leading to a scientific article and an implementation plan.
This study is funded by ZonMw.
