Testing the Effectiveness of Process Based Therapy in Routine Patient Care and Assessing Its Influence on Therapist Decision Making (PBACE)
9 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Tipo di studio
Interventistico
Iscrizione (Stimato)
60
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Ulrich Stangier, PhD
- Numero di telefono: 049 1707339293
- Email: stangier@psych.uni-frankfurt.de
Luoghi di studio
-
-
Hesse
-
Frankfurt am Main, Hesse, Germania, 60486
- Reclutamento
- JWGUniversity
-
Contatto:
- Ulrich Stangier Research Professor, PhD
- Numero di telefono: +491707339293
- Email: stangier@psych.uni-frankfurt.de
-
Investigatore principale:
- Ulrich Stangier, PhD
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
Intervention planning based on the use of EMA data, feedback of dynamic network analysis and matching of interventions to central nodes of the network.
Altri nomi:
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
|
|
Comparatore attivo: 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.
|
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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Depressive and anxiety symptom severity
Lasso di tempo: 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.
|
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.
|
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.
|
|
Positive Mental Health and Quality of Life
Lasso di tempo: 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.
|
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.
|
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.
|
|
Therapist Decision Making
Lasso di tempo: 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).
|
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.
|
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).
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Client satisfaction
Lasso di tempo: Assessed at post-treatment (week 28).
|
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.
|
Assessed at post-treatment (week 28).
|
|
Patient and Therapist Attitude Towards EMA-Assessment
Lasso di tempo: 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)
|
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.
|
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)
|
|
Therapist Treatment Evaluation
Lasso di tempo: Assessed at intermediate (week 6) and every four weeks in the treatment phase (Weeks 10, 14, 18 and 22).
|
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)
|
Assessed at intermediate (week 6) and every four weeks in the treatment phase (Weeks 10, 14, 18 and 22).
|
|
Self-Efficacy
Lasso di tempo: 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.
|
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.
|
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.
|
|
Decisional Self-Efficacy
Lasso di tempo: 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.
|
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.
|
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.
|
|
Therapeutic Alliance
Lasso di tempo: Assessed after randomization (Day 1), after completion of the EMA baseline phase (6-Week intermediate) and assessed at post-treatment (week 28).
|
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.
|
Assessed after randomization (Day 1), after completion of the EMA baseline phase (6-Week intermediate) and assessed at post-treatment (week 28).
|
|
Therapist Decision Making Style
Lasso di tempo: 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).
|
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.
|
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).
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Ulrich Stangier, PhD, Goethe Universität Frankfurt
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
27 giugno 2026
Completamento primario (Stimato)
1 gennaio 2029
Completamento dello studio (Stimato)
1 gennaio 2029
Date di iscrizione allo studio
Primo inviato
22 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
9 luglio 2026
Primo Inserito (Effettivo)
15 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
15 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2026-00-PBACE
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano 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.
Periodo di condivisione 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
Criteri di accesso alla condivisione 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 di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- CODICE_ANALITICO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .