An interventional study of Process-based Cognitive Behavioral Therapy (PBT) and Cognitive Behavioral Therapy (CBT) in Depression and Anxiety Disorder, sponsored by Goethe University. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by Goethe University · Not applicable, Interventional, and Treatment
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 80 is close to the median of 84 across 6,720 interventional studies indexed under Depression.
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Exclusion Criteria:
In PBT (20 sessions), treatment is initiated by a collaborative interpretation of the dynamic network model using smartphone-based Ecological Momentary Assessment collected during the baseline. Based on the outcome of the dynamic network model, interventions are selected on the basis of empirical evidence for mechanisms of change matching to the central node of the individual patient, besides feedback loops and self-loops, as the key process maintaining the maladaptive pattern. Interventions are conceptualized in the evolutionary framework as variation, selection and retention of an adaptive mode of the central node related to the specific context of the problem. The change of this variable is monitored using daily judgements on the basis of EMA. Further treatment planning focuses on additional targets to establish the adaptive modes of the dimensions as defined in the positive network model. Concomitant medication is allowed and will be controlled in statistical analyses.
Other: Process-based Cognitive Behavioral Therapy (PBT)
In r-CBT (20 sessions) a naturalistic setting is retained for treatment decisions. Treatment planning follows traditional theories about the effects of the interventions on factors maintaining the disorder, e.g. avoidance and exposure in anxiety disorder or reduced reinforcement of activities and behavioral activation in depression. Interventions are selected on the basis of common treatment manuals related to diagnoses, e.g. CBT for depression. Individual data from the behavioral analysis are used to taylor the techniques to the problem behaviors or dysfunctional thoughts of patients. Treatment process focuses mainly on the implementation of the manualized interventions adapted to the individual patient as recommended in the National guidelines for treatment of depression and anxiety disorders. Concomitant medication is allowed and will be controlled in statistical analyses.
Other: Cognitive Behavioral Therapy (CBT)
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.
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-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
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
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Individual participant data that underlie the results reported in the main publication of outcomes, after deidentification (text, tables, figures, and appendices) will be shared. Further Study Protocol, Analysis Plan, Informed Consent Form and Analytic Code will be shared to researchers who provide a methodologically sound proposal.
Supporting information: Study protocol, Sap, Icf, Analytic code
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