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Clinical Trials/NCT03945617
NCT03945617
Unknown
N/A

Optimizing Psychotherapy for Anxiety Disorders

University of Zurich1 site in 1 country200 target enrollmentJanuary 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anxiety Disorders
Sponsor
University of Zurich
Enrollment
200
Locations
1
Primary Endpoint
Hamilton Anxiety Rating Scale
Last Updated
6 years ago

Overview

Brief Summary

Anxiety disorders are highly prevalent and are associated with a high burden of disease, costs and individual impairment worldwide. Psychotherapy, especially cognitive behavioral therapy (CBT), is the first line treatment for anxiety disorders. CBT is effective in modifying dysfunctional cognitions and reducing avoidance behavior, thus leading to a lasting reduction of symptoms.

Even though CBT is generally effective, around 50% of patients do not benefit sufficiently from this treatment. The current study aims at optimizing the treatment of anxiety disorders by identifying predictors of treatment response. Multiple (neuro-)psychological, biological, genetic and behavioral variables will be combined into a comprehensive prediction model of treatment outcome. Knowledge on predictors can then be used to improve therapy on an individual patient level.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
December 31, 2023
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • aged between 18-65 years
  • one of the following primary axis I disorders according to the Diagnostic and Statistical Manual of Mental Disorders (DSM): Panic Disorder with or without Agoraphobia; Social Anxiety Disorder; Anxiety Disorder not otherwise specified, Adjustment Disorder with Anxiety, Adjustment Disorder with Mixed Anxiety and Depression; Specific Phobia; Generalized Anxiety Disorder
  • if on medication If on medication or in other types of treatments, patients must be willing to remain stable on their treatment for the duration of the acute phase/therapy of the study
  • not currently receiving other psychotherapeutic treatment for anxiety or another condition
  • fluent German
  • provision of written informed consent

Exclusion Criteria

  • concomitant psychotherapy
  • medical relative contraindications involve conditions that impede thorough exposure, e.g. cardiovascular diseases, autoimmune diseases or pregnancy
  • current or past schizophrenia, psychosis, or bipolar disorder
  • current suicidal ideation.
  • current substance/alcohol dependence or abuse
  • cluster A or B personality disorder
  • pregnancy (for women)

Outcomes

Primary Outcomes

Hamilton Anxiety Rating Scale

Time Frame: change from T0 (entry to study) at mid-treatment (8 weeks after T0), change from T0 at post-treatment (after 16 weeks from T0), change from T0 at 6 months follow-up and change from T0 at one year from post-treatment

clinician rating of anxiety symptoms, range: 0-56, with higher values representing a worse outcome

Overall Anxiety Severity and Impairment Scale

Time Frame: change from T0 (entry to study), at mid-treatment (8 weeks after T0), change from T0 at post-treatment (16 weeks after T0), change from T0 at 6 months follow-up and change from T0 at one year post-treatment

self-report measure of anxiety symptom severity and impairment; range: 0-20, with higher values representing worse outcome

Secondary Outcomes

  • Beck Depression Inventory(change from T0 (entry to study), at mid-treatment (8 weeks after T0), change from T0 at post-treatment (16 weeks after T0), change from T0 at 6 months follow-up and change from T0 at one year post-treatment)
  • Hamilton Depression Scale(change from T0 (entry to study), at mid-treatment (8 weeks after T0), change from T0 at post-treatment (16 weeks after T0), change from T0 at 6 months follow-up and change from T0 at one year post-treatment)
  • World Health Organization-5 Wellbeing Index(change from T0 (entry to study), at mid-treatment (8 weeks after T0), change from T0 at post-treatment (16 weeks after T0), change from T0 at 6 months follow-up and change from T0 at one year post-treatment)
  • Beck Anxiety Inventory(change from T0 (entry to study), at mid-treatment (8 weeks after T0), change from T0 at post-treatment (16 weeks after T0), change from T0 at 6 months follow-up and change from T0 at one year post-treatment)
  • Social Functioning Index (SFI)(change from T0 (entry to study), at mid-treatment (8 weeks after T0), change from T0 at post-treatment (16 weeks after T0), change from T0 at 6 months follow-up and change from T0 at one year post-treatment)

Study Sites (1)

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