Anxiety Disorders
Conditions
Keywords
anxiety, cognitive behavior therapy, transdiagnostic treatment, prediction
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.
Interventions
BEHAVIORALUnified Treatment Protocol
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.
Sponsors
Psychiatric University Hospital, Zurich
Swiss National Science Foundation
University of St.Gallen
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be blinded regarding treatment allocation
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Test of self-conscious affect | 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 to index self-conscious affect; 3 subscales: shame self-talk, guilt self-talk, blaming others; each ranging from 0 to 55, with higher values indicating a worse outcome |
| Thought Control questionnaire | 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 to assess worry and reappraisal as cognitive strategies/information processing; subscales worry (range: 1-24, with higher values indicating worse outcome) and reappraisal (range:1-24, with higher values representing better outcome) are reported |
Countries
Switzerland
Contacts
Primary ContactBirgit Kleim, Prof. Dr.
Backup ContactAva Schulz, Dr.
Outcome results
None listed