Schema Therapy for Treatment-resistant Anxiety Disorders

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 and/or 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).

Conditions

• Anxiety Disorders

Interventions

BEHAVIORAL

Individual Schema Therapy

Schema therapy focuses on adapting maladaptive "schemas" (i.e., core representations of oneself, others or the world) and dysfunctional personality traits, while also incorporating exposure therapy. It consists of a maximum of 40 sessions within one year.

OTHER

TAU

Treatment As Usual according to the Dutch Multidisciplinary Guidelines Anxiety Disorders and the Dutch Quality Standard for Anxiety Disorders. TAU often consists of a continuation of Cognitive Behavioral Therapy (CBT) and (different) medications, sometimes in a more treatment-intensive format. There are no restrictions to TAU, except that it may not be schema therapy. The actual content of TAU will be tracked.

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• ADF Stichting

  collaborator UNKNOWN

• University of Amsterdam

  collaborator OTHER

• Maastricht University

  collaborator OTHER

• GGZ inGeest

  collaborator OTHER

• Pro Persona Mental Health Care Foundation

  collaborator OTHER

• Mondriaan

  collaborator UNKNOWN

• GGNet

  collaborator UNKNOWN

• GGZ Delfland

  collaborator UNKNOWN

• Amsterdam UMC, location VUmc

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-01

Primary Completion

2024-09-30

Completion

2030-12-31