Clinical trial NCT06298695: Schema Therapy for Treatment-resistant Anxiety Disorders
Official title: Cost-effectiveness of Schema Therapy for Treatment-resistant Anxiety Disorders: A Multicentre RCT
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Keywords: agoraphobia
social anxiety disorder
generalized anxiety disorder
panic disorder
specific phobia
separation anxiety disorder
treatment-resistance
schema therapy
randomized controlled trial
cost-effectiveness
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: ADF Stichting
name: University of Amsterdam
name: Maastricht University
name: GGZ inGeest
name: Pro Persona Mental Health Care Foundation
name: Mondriaan
name: GGNet
name: GGZ Delfland
First posted: 2024-03-07
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multicenter parallel group randomized controlled clinical intervention trial
Primary purpose: TREATMENT

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 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).

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 (i.e. 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 and/or pharmacological treatment in TAU. The only restriction to TAU is that schema therapy may not be provided.

MAIN STUDY PARAMETERS/ENDPOINTS:

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 and/or 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 SIZE/DATA ANALYSIS A total of 172 patients will be enrolled (assuming a medium effect size d=0.5, testing two-sided using at ɑ=0.05, power = 0.80) 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.

Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of an anxiety disorder (panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder, separation anxiety disorder and specific phobia) based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
* Fulfilling the criteria of treatment-resistance based on a systematic literature search by Bokma and collegues: i) at least one unsuccessful CBT treatment of ≥ 8 weeks; and ii) at least one unsuccessful pharmacological treatment with a serotonergic antidepressant of ≥ 8 weeks, and iii) moderate to severe anxiety symptoms (BAI \> 11). The adequacy of previous treatment will be checked.

Exclusion Criteria:

* Substance use dependence
* Acute suicidality
* Has received schema therapy in the past
* Has insufficient language skills in Dutch and/or English

Primary outcomes:
measure: Changes in the severity of anxiety symptoms
timeFrame: Screening, baseline and at 1, 3, 6, 12, 24 and 36 months after baseline.
measure: Health-related quality of life
timeFrame: Baseline and at 1, 3, 6, 12, 24 and 36 months after baseline.
measure: Mental health quality of life
timeFrame: Baseline and at 1, 3, 6, 12, 24 and 36 months after baseline.
measure: Health care utilization and productivity losses
timeFrame: Baseline and at 1, 3, 6, 12, 24 and 36 months after baseline.
Secondary outcomes:
measure: Remission from the primary anxiety disorder and from comorbid disorders
timeFrame: Baseline, and at 12, 24 and 36 months after baseline.
measure: Screening for DSM-5 personality disorders
timeFrame: Baseline and at 1, 3, 6, 12, 24 and 36 months after baseline.
measure: Assessment of DSM-5 personality disorders
timeFrame: Baseline
measure: Demographics
timeFrame: Baseline
measure: (Strength of) treatment preference
timeFrame: Baseline and at 12 months after baseline.
measure: Assessment of childhood trauma
timeFrame: Baseline
measure: Assessment of autistic traits
timeFrame: Baseline
measure: Assessment of general mental health
timeFrame: Baseline and at 12, 24 and 36 months after baseline.
measure: Functioning and recovery in psychiatric patients
timeFrame: Baseline and 12, 24 and 36 months after baseline.
measure: Early Maladaptive Schemas
timeFrame: Baseline and at 12 and 36 months after baseline.
measure: Schema Modes
timeFrame: Baseline and at 3, 6, 12 and 36 months after baseline.
measure: Positive and negative effects of psychotherapy
timeFrame: At 12 months after baseline.
measure: The level of satisfaction with the psychological treatment
timeFrame: At 12 months after baseline.
Other outcomes:
Locations:
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