DepressionPBTRANDNCT06517589
Process-based Therapy for Difficult-to-treat Anxiety Disorders and Depression
A study testing Process-based Cognitive Behavioral Therapy (PBT) and Cognitive Behavioral Therapy (CBT) in people with Depression and Anxiety Disorder, run by Goethe University at 1 site in Germany.
Trial summary
The aim of this study is to test the relative efficacy of Process-based Therapy compared to traditional CBT delivered in routine practice (r-CBT) for difficult-to-treat anxiety disorders and depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Anxiety Disorder
- What is being tested?
- Process-based Cognitive Behavioral Therapy (PBT) and Cognitive Behavioral Therapy (CBT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 29 Jan 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 depressive or anxiety disorder
- At least two unsuccessful attempts of pharmacological or psychological treatment according to the German guidelines for the treatment of depression or anxiety disorders (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF)
- 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
- Borderline personality disorder
- Pervasive developmental disorder
- Psychotic disorder
- Eating disorder
- Bipolar disorder
- Severe physical illness
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
JWGUniversity
Frankfurt am Main, Hesse, 60486
Ulrich Stangier, Prof., 800-555-5555, stangier@psych.uni-frankfurt.de
Stangier, 0491707339293, stangier@psych.uni-frankfurt.de
About this study
Official title: Process-based Therapy vs. Routine-CBT for Difficult-to-treat Anxiety Disorders and Depression
The aim of this study is to test the relative efficacy of Process-based Therapy compared to traditional CBT delivered in routine practice (r-CBT) for difficult-to-treat anxiety disorders and depression.
Read the detailed description
Process-based Therapy (PBT) is a new framework to intervention planning, based on the use of ecological momentary assessment (EMA) data, feedback of dynamic network analysis and matching of interventions to central nodes of the network. Although preliminary support for its applicability has been reported from a single-case study, there are no data on the feasibility and effectiveness in a larger clinical sample. The investigators have translated a Training Manual of PBT and modified for delivery of CBT in Mental Health Service. The aim of this study is to test the relative efficacy of PBT compared to traditional CBT delivered in routine practice (r-CBT) for difficult-to-treat anxiety disorders and depression.
- Conditions
- Depression, Anxiety Disorder
- Being tested
- Process-based Cognitive Behavioral Therapy (PBT), Cognitive Behavioral Therapy (CBT)
- Medical subject headings
- Depression, 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
PBT (20 sessions), intervention planning based on the use of EMA data, feedback of dynamic network analysis and matching of interventions to central nodes of the network.
Cognitive Behavioral Therapy (CBT)Other
CBT (20 sessions), intervention planning as usual based on manual.
| Study group | Role | What they receive |
|---|---|---|
| Process-based Cognitive Behavioral Therapy | Experimental | In PBT (20 sessions), treatment is initiated by a collaborative interpretation of the dynamic network model using smartphone-based Ecological Momentary Assessment collected during the baseline. Based on the outcome of the dynamic network model, interventions are selected on the basis of empirical evidence for mechanisms of change matching to the central node of the individual patient, besides feedback loops and self-loops, as the key process maintaining the maladaptive pattern. Interventions are conceptualized in the evolutionary framework as variation, selection and retention of an adaptive mode of the central node related to the specific context of the problem. The change of this variable is monitored using daily judgements on the basis of EMA. Further treatment planning focuses on additional targets to establish the 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) |
| Traditional Cognitive Behavioral Therapy | Active comparator | In r-CBT (20 sessions) a naturalistic setting is retained for treatment decisions. Treatment planning follows traditional theories about the effects of the interventions on factors maintaining the disorder, e.g. avoidance and exposure in anxiety disorder or reduced reinforcement of activities and behavioral activation in depression. Interventions are selected on the basis of common treatment manuals related to diagnoses, e.g. CBT for depression. Individual data from the behavioral analysis are used to taylor the techniques to the problem behaviors or dysfunctional thoughts of patients. Treatment process focuses mainly on the implementation of the manualized interventions adapted to the individual patient as recommended in the National guidelines for treatment of depression and anxiety disorders. Concomitant medication is allowed and will be controlled in statistical analyses. Receives: Other: Cognitive Behavioral Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Anxiety Stress Scale (DASS-21)
Emotional distress, minimum value=0, maximum value=63, higher scores mean worse outcome
Measured: Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
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 at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
Positive-Mental Health Scale (PMH)
Positive mental health, minimum value=9, maximum value=36, higher scores mean better outcome
Measured: Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)
Pleasure in interpersonal situations, minimum value=17, maximum value=102, higher scores mean better outcome
Measured: Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
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 at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
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 at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
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 outcomes
Measured: Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
Client Satisfaction Questionnaire (CSQ-8)
Client Satisfaction, minimum value=8, maximum value=32, higher scores mean better outcome
Measured: Assessed at post-treatment at week 32
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 at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
Cognitive-Behavioral-Therapy Skills Questionnaire (CBTSQ)
Patients use of CBT interventions, minimum value=6, maximum value=42, higher scores mean better outcome
Measured: Assessed at inclusion, pre-treatment, weekly during the treatment (from week 11 to 30), at post-treatment (week 32) and at 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start29 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 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
- NCT06517589
- Sponsor's protocol ID
- III L5-519/05.000.002
- Acronym
- PBTRAND
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 30 Jul 2024
- 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.
Publications
Stangier U, Kohl V, Gorg N, Sendig L, Hufschmidt B, Bonarius D, Nemani A, Ebert M, Hofmann SG. Process-based therapy vs. routine-CBT for difficult-to-treat mood and anxiety disorders: study protocol for a randomized controlled trial. Trials. 2024 Dec 19;25(1):838. doi: 10.1186/s13063-024-08689-3.
PubMed 39702504
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Process-based Therapy vs. Routine-CBT for Difficult-to-treat Anxiety Disorders and Depression
- ClinicalTrials.gov ID
- NCT06517589
- Acronym / sponsor ID
- PBTRAND / III L5-519/05.000.002
- Conditions
- Depression, Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Collaborators
- Philipps University Marburg
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 24 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 aim of this study is to test the relative efficacy of Process-based Therapy compared to traditional CBT delivered in routine practice (r-CBT) for difficult-to-treat anxiety disorders and depression.
Detailed description
Process-based Therapy (PBT) is a new framework to intervention planning, based on the use of ecological momentary assessment (EMA) data, feedback of dynamic network analysis and matching of interventions to central nodes of the network. Although preliminary support for its applicability has been reported from a single-case study, there are no data on the feasibility and effectiveness in a larger clinical sample. The investigators have translated a Training Manual of PBT and modified for delivery of CBT in Mental Health Service. The aim of this study is to test the relative efficacy of PBT compared to traditional CBT delivered in routine practice (r-CBT) for difficult-to-treat anxiety disorders and depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Process-based Cognitive Behavioral Therapy | Experimental | Other: Process-based Cognitive Behavioral Therapy (PBT)In PBT (20 sessions), treatment is initiated by a collaborative interpretation of the dynamic network model using smartphone-based Ecological Momentary Assessment collected during the baseline. Based on the outcome of the dynamic network model, interventions are selected on the basis of empirical evidence for mechanisms of change matching to the central node of the individual patient, besides feedback loops and self-loops, as the key process maintaining the maladaptive pattern. Interventions are conceptualized in the evolutionary framework as variation, selection and retention of an adaptive mode of the central node related to the specific context of the problem. The change of this variable is monitored using daily judgements on the basis of EMA. Further treatment planning focuses on additional targets to establish the adaptive modes of the dimensions as defined in the positive network model. Concomitant medication is allowed and will be controlled in statistical analyses. |
| Traditional Cognitive Behavioral Therapy | Active comparator | Other: Cognitive Behavioral Therapy (CBT)In r-CBT (20 sessions) a naturalistic setting is retained for treatment decisions. Treatment planning follows traditional theories about the effects of the interventions on factors maintaining the disorder, e.g. avoidance and exposure in anxiety disorder or reduced reinforcement of activities and behavioral activation in depression. Interventions are selected on the basis of common treatment manuals related to diagnoses, e.g. CBT for depression. Individual data from the behavioral analysis are used to taylor the techniques to the problem behaviors or dysfunctional thoughts of patients. Treatment process focuses mainly on the implementation of the manualized interventions adapted to the individual patient as recommended in the National guidelines for treatment of depression and anxiety disorders. 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 (5 listed)
- A primary DSM-5 diagnosis of depressive or anxiety disorder
- At least two unsuccessful attempts of pharmacological or psychological treatment according to the German guidelines for the treatment of depression or anxiety disorders (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF)
- 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
- Borderline 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)PBT (20 sessions), intervention 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 |
| Cognitive Behavioral Therapy (CBT)CBT (20 sessions), intervention planning as usual based on manual. | Other | Traditional Cognitive Behavioral Therapy |
Primary outcome
Depression Anxiety Stress Scale (DASS-21)
Time frame: Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
Emotional distress, minimum value=0, maximum value=63, higher scores mean worse outcome
9 secondary outcomes
Euroqol-5D (EQ-5D)
Time frame: Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
Positive-Mental Health Scale (PMH)
Time frame: Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)
Time frame: Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
Depression Anxiety Stress Scale (DASS-10)
Time frame: Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
Acceptance and Action Questionnaire Version 2 (AAQ-2)
Time frame: Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
Reflective Functioning Questionnaire (RFQ-8)
Time frame: Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
Client Satisfaction Questionnaire (CSQ-8)
Time frame: Assessed at post-treatment at week 32
Process-based Assessment Tool (PBAT)
Time frame: Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
Cognitive-Behavioral-Therapy Skills Questionnaire (CBTSQ)
Time frame: Assessed at inclusion, pre-treatment, weekly during the treatment (from week 11 to 30), at post-treatment (week 32) and at 6 month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Derived from this study: PubMed 39702504Stangier U, Kohl V, Gorg N, Sendig L, Hufschmidt B, Bonarius D, Nemani A, Ebert M, Hofmann SG. Process-based therapy vs. routine-CBT for difficult-to-treat mood and anxiety disorders: study protocol for a randomized controlled trial. Trials. 2024 Dec 19;25(1):838. doi: 10.1186/s13063-024-08689-3.
- 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.
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 Cognitive Behavioral Therapy (CBT) in people with Depression 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 5 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: status not confirmed, as of the sponsor's last update on 30 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ulrich Stangier, PhD (049 1707339293, stangier@psych.uni-frankfurt.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Anxiety Stress Scale (DASS-21) (time frame: Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06517589, which also lists 1 linked publication.
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 30 Jul 2024.