Optimizing Psychotherapy for Anxiety Disorders

Study Overview
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Brief Summary
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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.

Official Title
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Optimizing Psychotherapy for Anxiety Disorders

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Behavioral: Unified Treatment Protocol


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is randomized controlled trial involving a before-after design with an intervention group that receives immediate access to treatment and a waitlist-control group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unified treatment protocol<br>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). | Behavioral: Unified Treatment Protocol<br>* The Unified Treatment Protocol (UP) is a transdiagnostic psychotherapeutic treatment manual for emotional disorders, that is based on CBT principles and focuses on changing dysfunctional emotion regulation.<br>|
| No Intervention: Waitlist Control Group<br>Participants in the waitlist control group gain access to the Unified Treatment after a waiting period of 16 weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Anxiety Rating Scale | clinician rating of anxiety symptoms, range: 0-56, with higher values representing a worse outcome | 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 | 
| Overall Anxiety Severity and Impairment Scale | self-report measure of anxiety symptom severity and impairment; range: 0-20, with higher values representing worse outcome | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Scale | clinician rating of depressive symptoms; range: 0-66, with higher values representing worse outcome | 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 Depression Inventory | self report measure of depression; range: 0-63, with higher values indicating worse outcome | 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 in social functioning; Subscales: work (range: 1-15) and leisure time (range: 1-30), with higher numbers indicating worse outcome | 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 in well-being; range: 0-25, with higher values indicating a better outcome | 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 | self-report in anxiety symptoms, range 0-63, with higher values representing worse outcome | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, cognitive behavior therapy, transdiagnostic treatment, prediction