An interventional study of Process Based Psychotherapy (PBT) and Routine practice in Depressive and Anxiety Disorders, sponsored by Goethe University. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Goethe University · Not applicable, Interventional, and Treatment
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Among 133 studies in Anxiety Disorders with a site in Germany — 27 open to participants now, 30 under way, none of them phase 3. Anxiety Disorders · Germany.
Among the 133 studies in Anxiety Disorders with a site in Germany, this one is the 74th largest by planned enrollment of the 99 interventional ones that give a count, is one of 6 that started in 2026, is one of 76 with no phase, reaches primary completion later than 28 of the 29 other live ones, and was the 132nd registered.
7,216 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
Browse Anxiety Disorders studies →27 of the 133 studies in Anxiety Disorders with a site in Germany are open now. Recruiting first, the newest first:
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) · Sites in Germany
Ages 18–99 · Women only
Dr. Nils B. Kroemer · Sites in Germany
Ages 18–40 · Healthy volunteers
Ruhr University of Bochum · Sites in Germany
Ages 18–65
Vera Guttenthaler · Sites in Germany
Ages 18+
Hannover Medical School · Sites in Germany
Ages 18+
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 945 Anxiety Disorders studies recruiting now, 417 (44%) set no upper age limit and 461 (49%) stop at 75 or younger; 233 take children under 18; 318 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
133 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 9 · Phase 3 10 · Phase 4 3
First in 2001; this study’s year is marked. 6 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is below the median of 80 across 6,071 interventional studies indexed under Anxiety Disorders.
Median enrollment 138 across the 99 interventional studies, 629 across the 33 observational. Of the 89 that completed or were terminated, 5 (6%) have results posted.
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19 of 133 have an industry lead sponsor. The 10 most frequent:
Goethe University is the lead sponsor of 98 studies on the registry; 15 are open to participants now.
Goethe University has 3 studies filed under Anxiety Disorders — fewer than ten, so there is no comparison to draw.
11 of the studies in Anxiety Disorders with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07568093Hannover Medical SchoolPARO-agitation-study | 2026-12 |
| NCT07270445Vera GuttenthalerEffect of Virtual Reality Use on Preoperative Anxiety | 2026-12-14 |
| NCT07432945Ruhr University of BochumIn Vivo Exposure vs. Videochat-Based Vicarious Exposure | 2026-12-31 |
| NCT07110896dsm-firmenich Switzerland AGStudy Evaluating the Effect of Humiome® Post LB on Stress, Anxiety, and Cognition in Aging Adults | 2027-02 |
| NCT07065240Seaport TherapeuticsA Study to Evaluate the Efficacy and Safety of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 Study) | 2027-03 |
Add all 11 to your calendar (.ics) → With an account.
Among the 133 studies in Anxiety Disorders with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Process Based Psychotherapy (PBT) · Drug: Psychiatric medication kept constant over study duration
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.
Other: Routine practice · Drug: Psychiatric medication kept constant over study duration
Intervention planning based on the use of EMA data, feedback of dynamic network analysis and matching of interventions to central nodes of the network.
Also known as: Process-based Therapy with Ecological Momentary Assessment
Intervention planning as usual.
Also known as: Routine psychotherapy
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
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.
Time frame: Assessed at post-treatment (week 28).
Patient and Therapist Attitude Towards EMA-Assessment
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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: 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
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.
Start is estimated for Jun 2026; primary completion for Jan 2029, 30 months later.
Of 3,851 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's planned 30 months is above that.
Counting every sponsor, half of 3,954 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
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