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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Process Based Psychotherapy (PBT) | Experimental | 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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| Routine practice (r-PT) | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Process Based Psychotherapy (PBT) | Other | Intervention planning based on the use of EMA data, feedback of dynamic network analysis and matching of interventions to central nodes of the network. |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive and anxiety symptom severity | 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 | 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 | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Client satisfaction | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ulrich Stangier, PhD | Contact | 049 1707339293 | stangier@psych.uni-frankfurt.de |
| Name | Affiliation | Role |
|---|---|---|
| Ulrich Stangier, PhD | Goethe Universität Frankfurt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JWGUniversity | Recruiting | Frankfurt am Main | Hesse | 60486 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Wilmers, F., & Munder, T. (2016). Der WAI-sr. In K. Geue, B. Strauß, & E. Brähler (Hrsg.), Diagnostische Verfahren in der Psychotherapie (3. Aufl.). Hogrefe. | ||
| Background | Someren, M. W. van, Barnard, Y. F., & Sandberg, J. A. (1994). The think aloud method: A practical guide to modelling cognitive processes. Academic Press. | ||
| Background | Schwarzer, R., & Jerusalem, M. (2012). General Self-Efficacy Scale [Dataset]. https://doi.org/10.1037/t00393-000 | ||
| Background | 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 | ||
| Background | Lovibond, S. H., & Lovibond, P. F. (2011). Depression Anxiety Stress Scales [Dataset]. https://doi.org/10.1037/t01004-000 | ||
| 32838671 |
| Label | URL |
|---|---|
| University Website | View source |
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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.
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
Proposals should be directed to stangier@psych.uni-frankfurt.de. To gain access, data requestors will need to sign a data access agreement.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 15, 2026 | May 15, 2026 |
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| Routine practice | Other | Intervention planning as usual. |
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| Psychiatric medication kept constant over study duration | Drug | 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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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 | 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 | 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 | 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 | 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 | 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). |
| Background |
| 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. |
| Background | Fiehn, H. (n.d.). The Therapist Decision Making Style Questionnaire. [Manuscript in preparation]. |
| 2286341 | Background | 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. |
| 8997937 | Background | 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. |
| 10259963 | Background | 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. |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000072860 | Ecological Momentary Assessment |
| ID | Term |
|---|---|
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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