Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Philipps University Marburg | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Depression Anxiety Stress Scale (DASS-21) | Emotional distress, minimum value=0, maximum value=63, higher scores mean worse outcome | Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up |
| 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 at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ulrich Stangier, PhD | Contact | 049 1707339293 | stangier@psych.uni-frankfurt.de |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JWGUniversity | Recruiting | Frankfurt am Main | Hesse | 60486 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39702504 | Derived | 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. |
| Label | URL |
|---|---|
| Website | View source |
Not provided
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.
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 23, 2024 | Jul 26, 2024 | Prot_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cognitive Behavioral Therapy (CBT) | Other | CBT (20 sessions), intervention planning as usual based on manual. |
|
| Positive-Mental Health Scale (PMH) | Positive mental health, minimum value=9, maximum value=36, higher scores mean better outcome | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |