Process-based Therapy for Difficult-to-treat Anxiety Disorders and Depression (PBTRAND)

Goethe University

Status: Enrolling

Conditions: Anxiety Disorder; Depression

Treatments: Other: Process-based Cognitive Behavioral Therapy (PBT); Other: Cognitive Behavioral Therapy (CBT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06517589

III L5-519/05.000.002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Process-based Cognitive Behavioral Therapy

Experimental group

Description:

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.

Treatment:

Other: Process-based Cognitive Behavioral Therapy (PBT)

Traditional Cognitive Behavioral Therapy

Active Comparator group

Description:

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.

Treatment:

Other: Cognitive Behavioral Therapy (CBT)