Depressive DisorderPBaPPNCT06530888
Feasibility of Process-based Therapy in a Naturalistic Setting
A study testing Process-based Cognitive Behavioral Therapy (PBT) and Routine practice (r-PT) in people with Depressive Disorder and Anxiety Disorder, run by Goethe University at 1 site in Germany.
Trial summary
The main objective is to explore the feasibility of Process-based Therapy in a natural mental health care setting delivered by practitioners. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Anxiety Disorder
- What is being tested?
- Process-based Cognitive Behavioral Therapy (PBT) and Routine practice (r-PT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 4 Nov 2023to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A primary DSM-5 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
Who cannot join
- Increased suicidality
- Substance abuse or dependency
- Diagnose of a cluster A or B (DSM-5) personality disorder
- Pervasive developmental disorder
- Psychotic disorder
- Eating disorder
- Bipolar disorder
- Severe physical illness
Trial locations and contacts
1 site in 1 country.
About this study
The main objective is to explore the feasibility of Process-based Therapy in a natural mental health care setting delivered by practitioners.
Read the detailed description
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).
- Conditions
- Depressive Disorder, Anxiety Disorder
- Being tested
- Process-based Cognitive Behavioral Therapy (PBT), Routine practice (r-PT)
- Keywords
- feasibility, Process-based Therapy
- Medical subject headings
- Depressive Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Process-based Cognitive Behavioral Therapy (PBT)Other
Also called Process-based Therapy with Ecological Momentary Assessment
Intervention planning based on the use of EMA data, feedback of dynamic network analysis and matching of interventions to central nodes of the network.
Routine practice (r-PT)Other
Intervention planning as usual.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Process-based Cognitive Behavioral Therapy (PBT) |
| 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. Receives: Other: Routine practice (r-PT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Satisfaction Questionnaire (CSQ)
Treatment satisfaction , minimum value= 8, maximum value= 32, higher scores mean better outcome
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From the time of randomization until the end of treatment, assessed no later than 28 weeks
Secondary outcomes (9)
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
Measured: Assessed after randomization and assessed until the end of treatment, assessed no later than 28 weeks at post-treatment
Positive-Mental Health Scale (PMH)
Psychological wellbeing, minimum value=9, maximum value=36, higher scores mean better outcome
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: CGI assessed after randomization (pre-treatment), CGI-I assessed until the end of treatment, assessed no later than 28 weeks at post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start4 Nov 2023
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Collaborators
- Philipps University Marburg
- Responsible party
- Principal investigator, Prof. Dr. Ulrich Stangier, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530888
- Sponsor's protocol ID
- III L5 - 519/05.000.002 - 2
- Acronym
- PBaPP
- Status last verified
- Mar 2026
- First submitted
- 27 Jul 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Process-based Therapy in a Naturalistic Setting
- ClinicalTrials.gov ID
- NCT06530888
- Acronym / sponsor ID
- PBaPP / III L5 - 519/05.000.002 - 2
- Conditions
- Depressive Disorder, Anxiety Disorder
- Keywords
- feasibility, Process-based Therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Collaborators
- Philipps University Marburg
- Study start
- 4 Nov 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective is to explore the feasibility of Process-based Therapy in a natural mental health care setting delivered by practitioners.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Process-based Cognitive Behavioral Therapy | Experimental | Other: Process-based Cognitive Behavioral Therapy (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 in statistical analyses. |
| Routine practice (r-PT) | Active comparator | Other: 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 in statistical analyses. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A primary DSM-5 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
Key exclusion criteria (8 listed)
- Increased suicidality
- Substance abuse or dependency
- Diagnose of a cluster A or B (DSM-5) personality disorder
- Pervasive developmental disorder
- Psychotic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Process-based Cognitive Behavioral Therapy (PBT)Also: Process-based Therapy with Ecological Momentary AssessmentIntervention planning based on the use of EMA data, feedback of dynamic network analysis and matching of interventions to central nodes of the network. | Other | Process-based Cognitive Behavioral Therapy |
| Routine practice (r-PT)Intervention planning as usual. | Other | Routine practice (r-PT) |
Primary outcome
Client Satisfaction Questionnaire (CSQ)
Time frame: From the time of randomization until the end of treatment, assessed no later than 28 weeks
Treatment satisfaction , minimum value= 8, maximum value= 32, higher scores mean better outcome
Patient attitude towards utility of EMA and networks Scale (PAUEN)
Time frame: From the time of randomization until the end of treatment, assessed no later than 28 weeks
Attitude towards utility of EMA and network models, minimum value= 8, maximum value= 40, higher scores mean better outcome
Therapist attitude towards utility of EMA and networks Scale (TAUEN)
Time frame: From the time of randomization until the end of treatment, assessed no later than 28 weeks
Attitude towards utility of EMA and network models, minimum value= 6, maximum value= 30, higher scores mean better outcome
Treatment Evaluation Inventory (TEI)
Time frame: From the time of randomization until the end of treatment, assessed no later than 28 weeks
Acceptance of treatment, minimum value= 7, maximum value= 98, higher scores mean better outcome
Attrition rate
Time frame: From the time of randomization until the end of treatment, assessed no later than 28 weeks
The percentage of participants who withdraw before completing the final assessment
9 secondary outcomes
Euroqol-5D (EQ-5D)
Time frame: Assessed after randomization and assessed until the end of treatment, assessed no later than 28 weeks at post-treatment
Positive-Mental Health Scale (PMH)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Assessed after randomization (pre-treatment)
Clinical Global Impression Scale (CGI) + (CGI-I)
Time frame: CGI assessed after randomization (pre-treatment), CGI-I assessed until the end of treatment, assessed no later than 28 weeks at post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- University websiteLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Process-based Cognitive Behavioral Therapy (PBT) and Routine practice (r-PT) in people with Depressive Disorder and Anxiety Disorder, run by Goethe University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Client Satisfaction Questionnaire (CSQ) (time frame: From the time of randomization until the end of treatment, assessed no later than 28 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026; AzTrials last refreshed its copy on 3 Nov 2026.