Process-based Therapy for Difficult-to-treat Anxiety Disorders and Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGoethe University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Increased suicidality
Substance abuse or dependency
Borderline personality disorder
Pervasive developmental disorder
Trial design
Design model
Parallel
Treatments tested in this trial
Process-based Cognitive Behavioral Therapy (PBT)
Other interventionPBT (20 sessions), intervention planning based on the use of EMA data, feedback of dynamic network analysis and matching of interventions to central nodes of the network.
Cognitive Behavioral Therapy (CBT)
Other interventionCBT (20 sessions), intervention planning as usual based on manual.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Process-based Cognitive Behavioral TherapyExperimental treatment 1 intervention
Group B: Traditional Cognitive Behavioral TherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Depression Anxiety Stress Scale (DASS-21)
Emotional distress, minimum value=0, maximum value=63, higher scores mean worse outcome
Time frame
Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-upSecondary outcomes
1
Euroqol-5D (EQ-5D)
Health related quality of life, minimum health state=11111, maximum health state=55555, higher scores in health state mean worse outcome, minimum health score=0, maximum health score=100, higher scores in health score mean better outcome
Time frame
Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up2
Positive-Mental Health Scale (PMH)
Positive mental health, minimum value=9, maximum value=36, higher scores mean better outcome
Time frame
Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up3
Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)
Pleasure in interpersonal situations, minimum value=17, maximum value=102, higher scores mean better outcome
Time frame
Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up4
Depression Anxiety Stress Scale (DASS-10)
Psychological symptoms of distress, depressive and anxious symptoms, minimum value=0, maximum value=30, higher scores mean worse outcome
Time frame
Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Goethe University
Lead sponsor
Philipps University Marburg
Collaborator
Source ClinicalTrials.gov