Agoraphobia Social anxiety disorer Specific phobia Generalized anxiety disorder Panic disorder Obsessive compulsive disorder unipolar depressive disorder (major depression or dysthymia) Posttraumatic stress disorder
Conditions
Interventions
Group 1: Multicenter prospective-longitudinal observational clinical study on patients with a primary diagnosis of an internalizing disorder (specific phobia (SP), social anxiety disorder (SAD), panic
Sponsors
Humboldt-Universität zu Berlin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria are: a primary diagnosis according to DSM-5 of specific phobia (SP), social anxiety disorder (SAD), panic disorder (PD), agoraphobia (AG), generalized anxiety disorder (GAD), obsessive-compulsive disorder (OCD), posttraumatic stress disorder (PTSD), unipolar depressive disorder (major depression or dysthymia, DD), age = 18, indication for outpatient CBT treatment, treatment dose of at least 12 sessions (excluding probatory sessions; 12 sessions is a minimal fixed dose of short-term treatment in the German health care system), symptom severity as indicated by a General Severity Index of the Brief Symptom Inventory (BSI-GSI) > 0.56 and a Clinical Global Impression – Severity Scale (CGI-S) score = 3 (mildly ill), willingness to participate in this study. Fostering ecological validity, exclusion criteria will be kept to a minimum.
Exclusion criteria
Exclusion criteria: We will exclude patients with a current secondary diagnosis of moderate to severe substance use disorder (including regular use of benzodiazepines), psychosis, bipolar disorder, acute suicidality and medical conditions as contraindication for CBT. Other comorbid disorders from the internalizing spectrum are not excluded. If outpatient treatment is interrupted due to inpatient treatment, patients will be excluded. Concurrent pharmacological treatment is not followed by exclusion, but will be documented in detail.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In defining treatment response we follow the concept of clinically significant change introduced by Jacobson & Truax. According to guidelines for the German academic outpatient sector, the transition from a dysfunctional to a functional mental condition is operationalized by meeting a BSI-GSI cutoff < 0.56 at T20/ post. Second, change from baseline to T20/ post has to be reliable as operationalized by the Reliable Change Index (RCI). | — |
Secondary
| Measure | Time frame |
|---|---|
| Disorder-specific severity measures will be used as secondary outcomes which are all based on clinical interviews. In line with other multicenter clinical studies a change of 50% symptom reduction in Hamilton Anxiety Rating Scale (HAM-A) will indicate treatment response in PD, AG, SAD, SP, and GAD. For DD, 50% symptom reduction in the Montgomery-Asberg rating Scale (MADRS), for OCD, a cutoff = 12 in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), and for PTSD, a 30% symptom reduction in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) applies. | — |
Countries
Germany
Contacts
Public ContactUlrike Lueken
Humboldt-Universität zu Berlin
Outcome results
None listed