Anxiety Disorder, Depression
Conditions
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.
Interventions
PBT (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.
OTHERCognitive Behavioral Therapy (CBT)
CBT (20 sessions), intervention planning as usual based on manual.
Sponsors
Philipps University Marburg
Goethe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression Anxiety Stress Scale (DASS-21) | Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up | Emotional distress, minimum value=0, maximum value=63, higher scores mean worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Euroqol-5D (EQ-5D) | Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up | 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 |
| Positive-Mental Health Scale (PMH) | Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up | Positive mental health, minimum value=9, maximum value=36, higher scores mean better outcome |
| Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS) | Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up | Pleasure in interpersonal situations, minimum value=17, maximum value=102, higher scores mean better outcome |
| Depression Anxiety Stress Scale (DASS-10) | Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up | Psychological symptoms of distress, depressive and anxious symptoms, minimum value=0, maximum value=30, higher scores mean worse outcome |
| Acceptance and Action Questionnaire Version 2 (AAQ-2) | Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up | Psychological flexibility and acceptance, minimum value=7, maximum value=49, higher scores mean worse outcome |
| Reflective Functioning Questionnaire (RFQ-8) | Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up | Reflective Functioning, minimum value=8, maximum value=56, higher scores on the uncertainty dimension mean worse outcome, higher scores in the certainty dimension mean better outcomes |
| Client Satisfaction Questionnaire (CSQ-8) | Assessed at post-treatment at week 32 | Client Satisfaction, minimum value=8, maximum value=32, higher scores mean better outcome |
| Process-based Assessment Tool (PBAT) | Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up | Variation, selection and retention of adaptive behavior, minimum value=0, maximum value=1800, higher scores mean better outcome |
| Cognitive-Behavioral-Therapy Skills Questionnaire (CBTSQ) | 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 | Patients use of CBT interventions, minimum value=6, maximum value=42, higher scores mean better outcome |
Countries
Germany
Contacts
Primary ContactUlrich Stangier, PhD
Outcome results
None listed