Clinical trial NCT06517589: Process-based Therapy for Difficult-to-treat Anxiety Disorders and Depression
Official title: Process-based Therapy vs. Routine-CBT for Difficult-to-treat Anxiety Disorders and Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Anxiety Disorder
Lead sponsor: Goethe University
Sponsor class: OTHER
Collaborators: name: Philipps University Marburg
First posted: 2024-07-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to test the relative efficacy of Process-based Therapy compared to traditional CBT delivered in routine practice (r-CBT) for difficult-to-treat anxiety disorders and depression.

Detailed description: 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

Primary outcomes:
measure: Depression Anxiety Stress Scale (DASS-21)
timeFrame: Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
Secondary outcomes:
measure: Euroqol-5D (EQ-5D)
timeFrame: Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
measure: Positive-Mental Health Scale (PMH)
timeFrame: Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
measure: Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)
timeFrame: Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
measure: Depression Anxiety Stress Scale (DASS-10)
timeFrame: Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
measure: Acceptance and Action Questionnaire Version 2 (AAQ-2)
timeFrame: Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
measure: Reflective Functioning Questionnaire (RFQ-8)
timeFrame: Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Assessed at post-treatment at week 32
measure: Process-based Assessment Tool (PBAT)
timeFrame: Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
measure: Cognitive-Behavioral-Therapy Skills Questionnaire (CBTSQ)
timeFrame: Assessed at inclusion, pre-treatment, weekly during the treatment (from week 11 to 30), at post-treatment (week 32) and at 6 month follow-up
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: JWGUniversity
state: Hessen
Study officials:
References: