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

Process-based Therapy vs. Routine-CBT for Difficult-to-treat Anxiety Disorders and Depression

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Anxiety Disorder
• Intervention / Treatment: Other: Process-based Cognitive Behavioral Therapy (PBT); Other: Cognitive Behavioral Therapy (CBT)

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ulrich Stangier, PhD; Phone Number: 049 1707339293; Email: stangier@psych.uni-frankfurt.de

Study Locations

• Germany
  • Hessen
    • Frankfurt am Main, Hessen, Germany, 60486
      • Recruiting
      • JWGUniversity
      • Contact: Ulrich Stangier, Prof.; Phone Number: 800-555-5555; Email: stangier@psych.uni-frankfurt.de
      • Contact: Stangier; Phone Number: 0491707339293; Email: stangier@psych.uni-frankfurt.de
      • Principal Investigator: Ulrich Stangier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Process-based Cognitive Behavioral Therapy; 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); 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.
Active Comparator: Traditional Cognitive Behavioral Therapy; 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); CBT (20 sessions), intervention planning as usual based on manual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression Anxiety Stress Scale (DASS-21)	Emotional distress, minimum value=0, maximum value=63, higher scores mean worse outcome	Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Goethe University
• Collaborators: Philipps University Marburg Medical Center

Publications and helpful links

Helpful Links

• Website

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): July 30, 2025

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 28, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: III L5-519/05.000.002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication. Data are available for 5 years at a third party website (Link to be included).
• IPD Sharing Access Criteria: Proposals should be directed to stangier@psych.uni-frankfurt.de. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No