Testing the Effectiveness of Process Based Therapy in Routine Patient Care and Assessing Its Influence on Therapist Decision Making (PBACE)
9 de julio de 2026 actualizado por: Prof. Dr. Ulrich Stangier, Goethe University
Process Based Therapy Applicability, Effectiveness and Compatibility (PBACE). A Within Therapist Randomized Controlled Trial Testing the Effectiveness of Process Based Therapy in Routine Patient Care and Assessing Its Influence on Therapist Decision Making
Background: Process Based Therapy (PBT) is a novel approach for a more personalized psychotherapy by integrating patient's ecological momentary assessment (EMA) data into treatment planning and focusing on empirically measured maladaptive processes. Previous pilot studies have examined the efficacy and feasibility of PBT in different settings. However, the effectiveness of this approach as well as the influence of providing EMA data on therapist's decision-making as well as treatment planning is yet unexplored.
Objective: This study aims to evaluate the effectiveness of PBT in a naturalistic setting as well examine the influence of the provision of EMA data on therapists' decision-making.
Methods: Thiry therapists as well as 60 patients will be recruited. Therapists will each treat two patients which are randomly allocated to either an intervention group receiving PBT or an active control group receiving routine psychotherapy. Treatment outcomes will be measured pre and post treatment as well as a 6-month follow-up. Therapists' decision making will be measured before training in PBT as well as during the treatment process using think aloud protocols (TAP) as well as quantitative measurements for decision making styles and self efficacy in decision making.
Discussion: This study could add insights into the ongoing research about the efficacy and effectiveness of PBT as well as provide insights into therapists' treatment decisions. While PBT holds theoretical promise for a more personalized and effective treatment, empirical data is still needed to assess its theoretical merit, which this study could provide. Expanding on the thus far scarce literature on decision-making in the therapeutic process, valuable information about processes guiding therapists' treatment decisions could be gained.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ulrich Stangier, PhD
- Número de teléfono: 049 1707339293
- Correo electrónico: stangier@psych.uni-frankfurt.de
Ubicaciones de estudio
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Hesse
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Frankfurt am Main, Hesse, Alemania, 60486
- Reclutamiento
- JWGUniversity
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Contacto:
- Ulrich Stangier Research Professor, PhD
- Número de teléfono: +491707339293
- Correo electrónico: stangier@psych.uni-frankfurt.de
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Investigador principal:
- Ulrich Stangier, PhD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- A primary ICD-11 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
- diagnosis of a cluster A or B (DSM-5) personality disorder
- pervasive developmental disorder, psychotic disorder, eating disorder, bipolar disorder, or severe physical illness.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Process Based Psychotherapy (PBT)
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 by the study design.
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Intervention planning based on the use of EMA data, feedback of dynamic network analysis and matching of interventions to central nodes of the network.
Otros nombres:
Psychiatric medication is kept constant during the trial.
Participants are not required to take medication.
If participants enlisting in the trial are on medication however, they will be asked to keep medication constant over the study duration
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Comparador activo: 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 by the study design.
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Psychiatric medication is kept constant during the trial.
Participants are not required to take medication.
If participants enlisting in the trial are on medication however, they will be asked to keep medication constant over the study duration
Intervention planning as usual.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Depressive and anxiety symptom severity
Periodo de tiempo: Assessed after randomization (Day 1), after completion of the EMA baseline phase (6-Week intermediate), assessed at post-treatment (week 28) and assessed at a six-month follow-up.
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To assess Psychopathological Stress , the Depression Anxiety Stress Scale 21 (DASS-21) is used.
The DASS-21 is a validated and reliable 21 item self-report instrument for the measurement of depressive and anxiety symptoms.
Additionally, stress as a negative affective state is measured on an additional subscale.
The scale ranges from 1-4 with higher mean values reflecting higher symptom severity in the respective subscale as well as an overall score of Psychopathological Stress.
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Assessed after randomization (Day 1), after completion of the EMA baseline phase (6-Week intermediate), assessed at post-treatment (week 28) and assessed at a six-month follow-up.
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Positive Mental Health and Quality of Life
Periodo de tiempo: Assessed after randomization (Day 1), after completion of the EMA baseline phase (6-Week intermediate), assessed at post-treatment (week 28) and assessed at a six-month follow-up.
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Positive mental health and quality of Life will be measured using the positive mental health scale (PMH).
The PMH is a validated nine-item self-report scale for the measurement of the presence of positive mental health.
Scores range form 1-4 with higher mean scores reflecting a more positive mental health.
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Assessed after randomization (Day 1), after completion of the EMA baseline phase (6-Week intermediate), assessed at post-treatment (week 28) and assessed at a six-month follow-up.
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Therapist Decision Making
Periodo de tiempo: Assessed pre-training in PBT (Day 0), at Day 1 of treatment, after diagnosis (Day 2), after a hypothetical model is developed (Day 3), after EMA-Assessment is complete (Week-6) and every four weeks during the treatment phase (Weeks 10, 14, 18 and 22).
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Therapist Decision Making regarding treatment planning will be measured using think-aloud protocols (TAP).
The think-aloud method is usually used to measure decision making in cognitive tasks such as problem solving, where participants are instructed to "think-aloud" meaning to verbalize their thoughts during a cognitive task.
In this study, therapists will be instructed to verbalize their treatment planning at nine measurement points.
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Assessed pre-training in PBT (Day 0), at Day 1 of treatment, after diagnosis (Day 2), after a hypothetical model is developed (Day 3), after EMA-Assessment is complete (Week-6) and every four weeks during the treatment phase (Weeks 10, 14, 18 and 22).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Client satisfaction
Periodo de tiempo: Assessed at post-treatment (week 28).
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Patient satisfaction at the end of treatment, measured with the Client Satisfaction Questionnaire (CSQ).
The CSQ uses 8 items with a range of 1-4 with higher mean values reflecting higher satisfaction with the recieved treatment.
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Assessed at post-treatment (week 28).
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Patient and Therapist Attitude Towards EMA-Assessment
Periodo de tiempo: Assessed at intermediate (week 6) and post-treatment (week 28) (PAUEN). Assessed at intermediate (week 6) and every four weeks in Treatment Phase (Weeks 10, 14, 18 and 22) (TAUEN)
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the therapist attitudes toward the utility of the EMA and networks scale (TAUEN) and the patient attitudes toward the utility of the EMA and networks scale (PAUEN) are modified versions of the Therapist and Client Attitudes Measures.
minimum value= 8, maximum value= 40, higher scores mean a higher attitude toward EMA and networks regarding their utility.
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Assessed at intermediate (week 6) and post-treatment (week 28) (PAUEN). Assessed at intermediate (week 6) and every four weeks in Treatment Phase (Weeks 10, 14, 18 and 22) (TAUEN)
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Therapist Treatment Evaluation
Periodo de tiempo: Assessed at intermediate (week 6) and every four weeks in the treatment phase (Weeks 10, 14, 18 and 22).
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The Treatment Evaluation Inventory will be used to assess therapists' perceptions of treatment.
It consists of 14 statements that are evaluated on a 7-point Likert scale, with response options spanning from -3 (strongly disagree) to +3 (strongly agree).
A higher mean score reflects a higher attitude towards the given treatment (e.g.
PBT or routine care)
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Assessed at intermediate (week 6) and every four weeks in the treatment phase (Weeks 10, 14, 18 and 22).
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Self-Efficacy
Periodo de tiempo: Assessed after randomization (Day 1), after completion of the EMA baseline phase (6-Week intermediate), assessed at post-treatment (week 28) and assessed at a six-month follow-up.
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Perceived general self-efficacy, meaning an optimistic self-belief that one can perform difficult or novel tasks or cope with adversity is measured by the General Self-Efficacy Scale (GSE).
The GSE is a 10-item self-report questionnaire with a validated one factor structure.
The GSE ranges from 1-4 with a higher mean score reflecting higher self-efficacy.
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Assessed after randomization (Day 1), after completion of the EMA baseline phase (6-Week intermediate), assessed at post-treatment (week 28) and assessed at a six-month follow-up.
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Decisional Self-Efficacy
Periodo de tiempo: Assessed after randomization (Day 1), after completion of the EMA baseline phase (6-Week intermediate), assessed at post-treatment (week 28) and assessed at a six-month follow-up.
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Decision making self-efficacy is measured using the Decision Self-Efficacy Scale.
The DSE is an 11-item self-report instrument measuring self-efficacy in the domain of treatment decisions.
The DSE ranges from 0-4 with higher mean scores reflecting a higher confidence and self-efficacy in treatment decisions.
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Assessed after randomization (Day 1), after completion of the EMA baseline phase (6-Week intermediate), assessed at post-treatment (week 28) and assessed at a six-month follow-up.
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Therapeutic Alliance
Periodo de tiempo: Assessed after randomization (Day 1), after completion of the EMA baseline phase (6-Week intermediate) and assessed at post-treatment (week 28).
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Therapeutic Alliance is measured at patient level using the Working Alliance Inventory Short Revised Patient Version (WAI-SR-P).
The WAI-SR-P measures therapeutic alliance from the patient's perspective using 12 items as a self report ranging from 1-5 with higher mean scores reflecting a stronger and more positive working alliance as perceived by the patient.
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Assessed after randomization (Day 1), after completion of the EMA baseline phase (6-Week intermediate) and assessed at post-treatment (week 28).
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Therapist Decision Making Style
Periodo de tiempo: Assessed pre-training in PBT (Day 0), at Day 1 of treatment, after diagnosis (Day 2), after a hypothetical model is developed (Day 3), after EMA-Assessment is complete (Week-6) and every four weeks during the treatment phase (Weeks 10, 14, 18 and 22).
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Therapists' Decision Making Styles will be measured using the therapist decision making questionnaire (TDMQ).
The TDMQ is a self-report scale measuring therapists' decision-making style using 23 items on a scale from 1 to 5. Higher mean scores on a specific subscale reflect a decision style that puts a higher emphasis on the sources of information belonging to that specific decision making style.
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Assessed pre-training in PBT (Day 0), at Day 1 of treatment, after diagnosis (Day 2), after a hypothetical model is developed (Day 3), after EMA-Assessment is complete (Week-6) and every four weeks during the treatment phase (Weeks 10, 14, 18 and 22).
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Ulrich Stangier, PhD, Goethe Universität Frankfurt
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.
- Wilmers, F., & Munder, T. (2016). Der WAI-sr. In K. Geue, B. Strauß, & E. Brähler (Hrsg.), Diagnostische Verfahren in der Psychotherapie (3. Aufl.). Hogrefe.
- Someren, M. W. van, Barnard, Y. F., & Sandberg, J. A. (1994). The think aloud method: A practical guide to modelling cognitive processes. Academic Press.
- Schwarzer, R., & Jerusalem, M. (2012). General Self-Efficacy Scale [Dataset]. https://doi.org/10.1037/t00393-000
- Lukat, J., Margraf, J., Lutz, R., Van Der Veld, W. M., & Becker, E. S. (2019). Positive Mental Health Scale [Dataset]. https://doi.org/10.1037/t74178-000
- Lovibond, S. H., & Lovibond, P. F. (2011). Depression Anxiety Stress Scales [Dataset]. https://doi.org/10.1037/t01004-000
- Frumkin MR, Piccirillo ML, Beck ED, Grossman JT, Rodebaugh TL. Feasibility and utility of idiographic models in the clinic: A pilot study. Psychother Res. 2021 Apr;31(4):520-534. doi: 10.1080/10503307.2020.1805133. Epub 2020 Aug 24.
- Fiehn, H. (n.d.). The Therapist Decision Making Style Questionnaire. [Manuscript in preparation].
- Burgio LD, Sinnott J. Behavioral treatments and pharmacotherapy: acceptability ratings by elderly individuals in residential settings. Gerontologist. 1990 Dec;30(6):811-6. doi: 10.1093/geront/30.6.811.
- Bunn H, O'Connor A. Validation of client decision-making instruments in the context of psychiatry. Can J Nurs Res. 1996 Fall;28(3):13-27.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
27 de junio de 2026
Finalización primaria (Estimado)
1 de enero de 2029
Finalización del estudio (Estimado)
1 de enero de 2029
Fechas de registro del estudio
Enviado por primera vez
22 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
9 de julio de 2026
Publicado por primera vez (Actual)
15 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-00-PBACE
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
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.
Marco de tiempo para compartir IPD
Beginning 3 months and ending 5 years following article publication.
Data are available for 5 years at the Open Science Forum under: https://doi.org/10.17605/OSF.IO/TVKMQ
Criterios de acceso compartido de IPD
Proposals should be directed to stangier@psych.uni-frankfurt.de.
To gain access, data requestors will need to sign a data access agreement.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .