Feasibility of Process-based Therapy in a Naturalistic Setting (PBaPP)

The main objective is to explore the feasibility of Process-based Therapy in a natural mental health care setting delivered by practitioners.

Study Overview

• Status: Active, not recruiting
• Conditions: Depressive Disorder; Anxiety Disorder
• Intervention / Treatment: Other: Routine practice (r-PT); Other: Process-based Cognitive Behavioral Therapy (PBT)

Detailed Description

In the naturalistic setting of mental health care, treatment decisions of psychotherapists are often based on theories or experience related to treatment approaches. An alternative approach to treatment decision is suggested by Process-based Therapy (PBT), which emphasizes empirical and rational criteria for the selection of intervention. It utilizes ecological momentary assessment (EMA) data, incorporates feedback from dynamic network analysis, and supports interventions based on individual network models and empirical evidence from research related to change processes. Currently, there are no data on the feasibility and acceptability of PBT in practice. The present study investigates in a naturalistic setting, whether PBT can be implemented by psychotherapists in mental health care. Furthermore, the investigators explore the acceptability and first indications of efficacy of PBT delivered in routine practice (r-PT).

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60486
      • JWGUniversity

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• A primary DSM-5 diagnosis of a depressive or anxiety disorder
• 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
• Diagnose of a cluster A or B (DSM-5) 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: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Process-based Cognitive Behavioral Therapy; In PBT, treatment planning is based on a dynamic network analysis of EMA data collected during the baseline phase. Therapists identify the central node, significant edges, self-loops, and feedback loops between the nodes. Using this information, interventions are selected based on empirical evidence for mechanisms of change that correspond to the network characteristics. These interventions are framed within an evolutionary framework as the variation, selection, and retention of an adaptive mode of the central node in relation to the specific context of the problem. The change in this key variable is monitored through daily judgments based on EMA. Treatment also focuses on additional targets to establish 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); Intervention planning based on the use of EMA data, feedback of dynamic network analysis and matching of interventions to central nodes of the network.; Other Names: Process-based Therapy with Ecological Momentary Assessment
Active Comparator: Routine practice (r-PT); In r-PT, as opposed to PBT, a naturalistic setting is retained for treatment decisions. Treatment planning follows traditional theories about the factors maintaining the disorder and interventions changing them, e.g. avoidance and exposure in anxiety disorders or reduced reinforcement of activities and behavioral activation in depression. Interventions are based on common treatment manuals related to diagnoses, e.g. CBT for depression. Individual data from the behavioral analysis are used to tailor the techniques to the individual problems of the patients. Treatment process is largely structured by personal preferences of the therapist due to experience, knowledge or recommendations of the National guidelines for the mental health problem.Concomitant medication is allowed and will be controlled in statistical analyses.	Other: Routine practice (r-PT); Intervention planning as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client Satisfaction Questionnaire (CSQ)	Treatment satisfaction , minimum value= 8, maximum value= 32, higher scores mean better outcome	From the time of randomization until the end of treatment, assessed no later than 28 weeks
Patient attitude towards utility of EMA and networks Scale (PAUEN)	Attitude towards utility of EMA and network models, minimum value= 8, maximum value= 40, higher scores mean better outcome	From the time of randomization until the end of treatment, assessed no later than 28 weeks
Therapist attitude towards utility of EMA and networks Scale (TAUEN)	Attitude towards utility of EMA and network models, minimum value= 6, maximum value= 30, higher scores mean better outcome	From the time of randomization until the end of treatment, assessed no later than 28 weeks
Treatment Evaluation Inventory (TEI)	Acceptance of treatment, minimum value= 7, maximum value= 98, higher scores mean better outcome	From the time of randomization until the end of treatment, assessed no later than 28 weeks
Attrition rate	The percentage of participants who withdraw before completing the final assessment	From the time of randomization until the end of treatment, assessed no later than 28 weeks

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 after randomization and assessed until the end of treatment, assessed no later than 28 weeks at post-treatment
Positive-Mental Health Scale (PMH)	Psychological wellbeing, minimum value=9, maximum value=36, higher scores mean better outcome	Assessed after randomization and assessed until the end of treatment, assessed no later than 28 weeks at post-treatment
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 after randomization, after completion of the EMA baseline phase (intermediate) and assessed until the end of treatment, assessed no later than 28 weeks at post-treatment (week 28)
Acceptance and Action Questionnaire Version 2 (AAQ-2)	Psychological flexibility and acceptance, minimum value=7, maximum value=49, higher scores mean worse outcome	Assessed after randomization, after completion of the EMA baseline phase (intermediate) and assessed until the end of treatment, assessed no later than 28 weeks at post-treatment
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 outcome	Assessed after randomization, after completion of the EMA baseline phase (intermediate) and assessed until the end of treatment, assessed no later than 28 weeks at post-treatment
Process-based Assessment Tool (PBAT)	Variation, selection and retention of adaptive behavior, minimum value=0, maximum value=1800, higher scores mean better outcome	Assessed after randomization, after completion of the EMA baseline phase (intermediate) and assessed until the end of treatment, assessed no later than 28 weeks at post-treatment
Cognitive-Behavioral-Therapy Skills Questionnaire (CBTSQ)	Patients use of CBT interventions, minimum value=6, maximum value=42, higher scores mean better outcome	Assessed after randomization, after completion of the EMA baseline phase (intermediate) and assessed until the end of treatment, assessed no later than 28 weeks at post-treatment
Credibility/Expectancy Questionnaire (CEQ)	six items, divided into two subscales that capture credibility and expectancy	Assessed after randomization (pre-treatment)
Clinical Global Impression Scale (CGI) + (CGI-I)	assesses the clinician's overall evaluation of the severity of a mental disorder and is utilized to monitor changes in symptom severity over time	CGI assessed after randomization (pre-treatment), CGI-I assessed until the end of treatment, assessed no later than 28 weeks at post-treatment

Collaborators and Investigators

• Sponsor: Goethe University
• Collaborators: Philipps University Marburg

Publications and helpful links

Helpful Links

• University website

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2023
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: July 27, 2024
• First Submitted That Met QC Criteria: July 27, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: feasibility; Process-based Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Anxiety Disorders; Depressive Disorder; Behavioral Disciplines and Activities; Psychological Tests; Ecological Momentary Assessment
• Other Study ID Numbers: III L5 - 519/05.000.002 - 2

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