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Process-based Therapy for Difficult-to-treat Anxiety Disorders and Depression
NCT06517589 · Goethe University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Process-based Therapy vs. Routine-CBT for Difficult-to-treat Anxiety Disorders and Depression
About this study
Process-based Therapy (PBT) is a new framework to intervention planning, based on the use of ecological momentary assessment (EMA) data, feedback of dynamic network analysis and matching of interventions to central nodes of the network. Although preliminary support for its applicability has been reported from a single-case study, there are no data on the feasibility and effectiveness in a larger clinical sample. The investigators have translated a Training Manual of PBT and modified for delivery of CBT in Mental Health Service. The aim of this study is to test the relative efficacy of PBT compared to traditional CBT delivered in routine practice (r-CBT) for difficult-to-treat anxiety disorders and depression.
Eligibility criteria
Inclusion Criteria:
* A primary DSM-5 diagnosis of depressive or anxiety disorder
* At least two unsuccessful attempts of pharmacological or psychological treatment according to the German guidelines for the treatment of depression or anxiety disorders (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF)
* Age 18-65 years
* Sufficient knowledge of the German language
* Participating patients are not required to discontinue medication, but to keep medication constant over the treatment period
Exclusion Criteria:
* Increased suicidality
* Substance abuse or dependency
* Borderline personality disorder
* Pervasive developmental disorder
* Psychotic disorder
* Eating disorder
* Bipolar disorder
* Severe physical illness
Study design
Enrollment target: 80 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2024-01-29
Estimated completion: 2025-07-30
Last updated: 2024-07-30
Interventions
Other: Process-based Cognitive Behavioral Therapy (PBT)Other: Cognitive Behavioral Therapy (CBT)
Primary outcomes
- • Depression Anxiety Stress Scale (DASS-21) (Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up)
Sponsor
Goethe University · other
With: Philipps University Marburg
Contacts & investigators
ContactUlrich Stangier, PhD · contact · stangier@psych.uni-frankfurt.de · 049 1707339293
All locations (1)
JWGUniversityRecruiting
Frankfurt am Main, Hesse, Germany