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| Name | Class |
|---|---|
| Psychiatric University Hospital, Zurich | OTHER |
| Swiss National Science Foundation | OTHER |
| University of St.Gallen | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unified treatment protocol | Experimental | 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). |
|
| Waitlist Control Group | No Intervention | Participants in the waitlist control group gain access to the Unified Treatment after a waiting period of 16 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unified Treatment Protocol | Behavioral | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Test of self-conscious affect | 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 | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Birgit Kleim, Prof. Dr. | Contact | +41 (0)44 384 23 51 | b.kleim@psychologie.uzh.ch | |
| Ava Schulz, Dr. | Contact | +41(0)443891582 | ava.schulz@uzh.ch |
| Name | Affiliation | Role |
|---|---|---|
| Birgit Kleim, Prof. Dr. | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Zurich | Recruiting | Zurich | 8032 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39153405 | Derived | Meine LE, Muller-Bardorff M, Recher D, Paersch C, Schulz A, Spiller T, Galatzer-Levy I, Kowatsch T, Fisher AJ, Kleim B. Network analyses of ecological momentary emotion and avoidance assessments before and after cognitive behavioral therapy for anxiety disorders. J Anxiety Disord. 2024 Aug;106:102914. doi: 10.1016/j.janxdis.2024.102914. Epub 2024 Aug 13. | |
| 38743473 |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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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.
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Outcome assessors will be blinded regarding treatment allocation
| 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 |
| Thought Control questionnaire | 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 | 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 |
| Muller-Bardorff M, Schulz A, Paersch C, Recher D, Schlup B, Seifritz E, Kolassa IT, Kowatsch T, Fisher A, Galatzer-Levy I, Kleim B. Optimizing Outcomes in Psychotherapy for Anxiety Disorders Using Smartphone-Based and Passive Sensing Features: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 May 14;13:e42547. doi: 10.2196/42547. |