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| Name | Class |
|---|---|
| Philipps University Marburg | OTHER |
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The main objective is to explore the feasibility of Process-based Therapy in a natural mental health care setting delivered by practitioners.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Process-based Cognitive Behavioral Therapy | 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 in statistical analyses. |
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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 in statistical analyses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Process-based Cognitive Behavioral Therapy (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 |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JWGUniversity | Frankfurt am Main | Hesse | 60486 | Germany |
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| 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 a third-party website (Link to be included).
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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Updated Study Protocol | Feb 5, 2026 | Mar 17, 2026 | Prot_SAP_001.pdf |
| Prot | Yes | No | No | Study Protocol: Original Study Protocol | Aug 1, 2024 | Aug 7, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| 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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| Routine practice (r-PT) | Other | Intervention planning as usual. |
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| 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 |