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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
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.
CBT (20 sessions), intervention planning as usual based on manual.
JWGUniversity
Frankfurt am Main, Hesse, Germany
RECRUITINGDepression 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-up
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-up
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-up
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-up
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-up
Acceptance and Action Questionnaire Version 2 (AAQ-2)
Psychological flexibility and acceptance, minimum value=7, maximum value=49, higher scores mean worse outcome
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Time frame: Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
Reflective Functioning Questionnaire (RFQ-8)
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
Time frame: Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
Client Satisfaction Questionnaire (CSQ-8)
Client Satisfaction, minimum value=8, maximum value=32, higher scores mean better outcome
Time frame: Assessed at post-treatment at week 32
Process-based Assessment Tool (PBAT)
Variation, selection and retention of adaptive behavior, minimum value=0, maximum value=1800, higher scores mean better outcome
Time frame: Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
Cognitive-Behavioral-Therapy Skills Questionnaire (CBTSQ)
Patients use of CBT interventions, minimum value=6, maximum value=42, higher scores mean better outcome
Time frame: 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