Schema Therapy for Treatment-resistant Anxiety Disorders

NCT06298695 | Not Yet Recruiting

• 2 other identifiers: 201293910390022210010
• Study Type: interventional
• Target: 172
• Locations: 0 countries
• Sites: N/A

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).

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

Outcome Measures

Primary Outcomes (4)

• Changes in the severity of anxiety symptoms

  Changes in the severity of anxiety symptoms are measured with the 21-item self-report Beck Anxiety Inventory (BAI), assessing somatic and affective-cognitive symptom domains. The total score ranges from 0 to 63, with higher scores indicating more severe anxiety symptoms. A score above 11 indicates clinically significant symptoms.

  Screening, baseline and at 1, 3, 6, 12, 24 and 36 months after baseline.

• Health-related quality of life

  Health-related quality of life, which is used for the cost-utility analysis, is assessed with the 5-item, self-report Health-Related Quality of Life Measure Euroqol (EQ5D-5L). The EQ5D-5L measures five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The dimension scores can be translated into a single index value. Additionally, the EQ5D-5L estimates the general self-reported health-related quality of life on a visual analogue scale, ranging from 0 (worst quality of life) to 100 (best quality of life).

  Baseline and at 1, 3, 6, 12, 24 and 36 months after baseline.

• Mental health quality of life

  Mental health quality of life, which is used for the cost-utility analysis, is measured with the 7-item, self-report Mental Health Quality of Life (MHQoL). The MHQoL encompasses seven dimensions: self-image, independence, mood, relationships, daily activities, physical health and hope. Total scores range from 0 to 21, with higher scores indicating better quality of life. In addition, the MHQoL assesses self-reported general psychological well-being on a visual analogue scale, ranging from 0 (low well-being) to 10 (high well-being).

  Baseline and at 1, 3, 6, 12, 24 and 36 months after baseline.

• Health care utilization and productivity losses

  Health care utilization and productivity losses, which are used for the cost-utility analysis, are assessed with the 57-item, self-report Treatment Inventory of Costs in Patients with psychiatric disorders (TiC-P). The TiC-P measures two dimensions: health care use in psychiatric patients and (voluntary) work and care tasks. The IMTA Productivity Cost Questionnaire (iPCQ) is part of the TiC-P questionnaire and measures absenteeism, presenteeism and productivity loss in unpaid work.

  Baseline and at 1, 3, 6, 12, 24 and 36 months after baseline.

Secondary Outcomes (13)

• Remission from the primary anxiety disorder and from comorbid disorders

  Baseline, and at 12, 24 and 36 months after baseline.

• Screening for DSM-5 personality disorders

  Baseline and at 1, 3, 6, 12, 24 and 36 months after baseline.

• Assessment of DSM-5 personality disorders

  Baseline

• Demographics

  Baseline

• (Strength of) treatment preference

  Baseline and at 12 months after baseline.

Study Arms (2)

Individual Schema Therapy

EXPERIMENTAL

A maximum of 40 sessions of individual schema therapy within one year

Behavioral: Individual Schema Therapy

Treatment As Usual (TAU)

ACTIVE COMPARATOR

Treatment as usual in treatment-resistant anxiety disorders (psychological and/or psychiatric).

Other: TAU

Interventions

Individual Schema Therapy BEHAVIORAL

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.

Individual Schema Therapy

TAU OTHER

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.

Treatment As Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• ADF Stichting: collaborator
• University of Amsterdam: collaborator
• Maastricht University: collaborator
• GGZ inGeest: collaborator
• Pro Persona Mental Health Care Foundation: collaborator
• Mondriaan: collaborator
• GGNet: collaborator
• GGZ Delfland: collaborator

MeSH Terms

Conditions

Anxiety Disorders; Agoraphobia; Phobia, Social; Generalized Anxiety Disorder; Panic Disorder; Phobia, Specific; Anxiety, Separation

Condition Hierarchy (Ancestors)

Mental Disorders; Phobic Disorders; Neurodevelopmental Disorders

Central Study Contacts

Anna Muntingh, PhD

CONTACT

+31 20 788 4666; a.muntingh@ggzingeest.nl

Willemijn Scholten, PhD

CONTACT

+31 20 788 4666; w.scholten@ggzingeest.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: A multicenter parallel group randomized controlled clinical intervention trial

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 7, 2024
• Study Start: September 1, 2024
• Primary Completion: September 30, 2024
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share