Optimizing Psychotherapy for Anxiety Disorders

Not Applicable

• Conditions: Anxiety Disorders
• Interventions: Behavioral: Unified Treatment Protocol

• Registration Number: NCT03945617
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-07-27
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-08
• Last Update Submitted: 2019-05-08
• Study First Posted: 2019-05-10
• Last Update Posted: 2019-05-10
• Primary Completion: 2022-05-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unified treatment protocol	Unified Treatment Protocol	This intervention group receives 16 sessions of CBT-based, individual psychotherapy using to the Unified Treatment Protocol for the treatment of emotional disorders by Barlow et al. (2011).

Primary Outcome Measures

Name	Time	Method
Hamilton Anxiety Rating Scale	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	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 Outcome Measures

Name	Time	Method
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	self report measure of depression; range: 0-63, with higher values indicating worse outcome
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	clinician rating of depressive symptoms; range: 0-66, with higher values representing worse outcome
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	change in well-being; range: 0-25, with higher values indicating a better outcome
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	self-report in anxiety symptoms, range 0-63, with higher values representing worse outcome
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	change in social functioning; Subscales: "work" (range: 1-15) and "leisure time" (range: 1-30), with higher numbers indicating worse outcome

Trial Locations

Locations (1)

University of Zurich; 🇨🇭 Zürich, Switzerland