Evaluation of a transdiagnostic mental health intervention in German primary care: study protocol for a parallel-group, two-arm, cluster randomised controlled pilot study
Abstract Background General practitioners play an important role in the first-line care of individuals with mental health conditions. However, factors such as time constraints, limited experience in managing mental health conditions and high rates of comorbidity may hinder adequate treatment. To imp...
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| Language: | English |
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BMC
2025-01-01
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| Series: | Pilot and Feasibility Studies |
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| Online Access: | https://doi.org/10.1186/s40814-025-01597-6 |
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| author | Christopher Ebert Marie Vogel Jochen Gensichen Hanna Reif Lena Grögor Lukas Junker Thomas Ehring Alkomiet Hasan Stefan Leucht Kirsten Lochbühler for the POKAL-Group |
| author_facet | Christopher Ebert Marie Vogel Jochen Gensichen Hanna Reif Lena Grögor Lukas Junker Thomas Ehring Alkomiet Hasan Stefan Leucht Kirsten Lochbühler for the POKAL-Group |
| author_sort | Christopher Ebert |
| collection | DOAJ |
| description | Abstract Background General practitioners play an important role in the first-line care of individuals with mental health conditions. However, factors such as time constraints, limited experience in managing mental health conditions and high rates of comorbidity may hinder adequate treatment. To improve psychological care, adopting a transdiagnostic approach shows potential. Research on transdiagnostic interventions delivered by general practitioners is scarce. Thus, a transdiagnostic intervention adapted from the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders was developed specifically for primary care. In a parallel-group, two-arm, cluster randomised controlled pilot study, the transdiagnostic intervention will be evaluated for feasibility, acceptability and potential effectiveness in German primary care. Methods A total of 100 adult patients with a mental health condition will be recruited by general practitioners. In the intervention group, general practitioners will administer the transdiagnostic intervention, introducing patients to psychological concepts based on transdiagnostic factors (i.e., understanding emotions, cognitive flexibility, countering emotion-based avoidance). In the control group, general practitioners will provide improved treatment as usual oriented on official German treatment guidelines for depression, anxiety and somatoform disorders. In both study groups, treatment will be carried out in four 20-min sessions over 12-weeks. Self-report questionnaires will be completed before treatment initiation (only patients) and after treatment completion (patients and general practitioners) to assess feasibility and acceptability (i.e., treatment recruitment, delivery, response, effectiveness, unintended consequences and maintenance) as well as potential effectiveness (i.e., change in transdiagnostic factors). Discussion The pilot study will address the research gap concerning general practitioner-led psychological interventions in primary care and will give insights into whether the adoption of a transdiagnostic approach is of benefit to general practitioners and patients. Findings may inform the design of a main trial by identifying barriers to the transdiagnostic intervention’s feasibility and acceptability, whilst advancing treatment delivery protocols to support effectiveness. Trial registration The protocol for this study has been registered with the German Clinical Trials Register: DRKS00033386, Date of registration: 18th of March 2024, https://drks.de/search/en/trial/DRKS00033386 . |
| format | Article |
| id | doaj-art-3e9f289d6bc1420cbbd94cd16174449d |
| institution | Kabale University |
| issn | 2055-5784 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj-art-3e9f289d6bc1420cbbd94cd16174449d2025-02-02T12:09:16ZengBMCPilot and Feasibility Studies2055-57842025-01-0111111210.1186/s40814-025-01597-6Evaluation of a transdiagnostic mental health intervention in German primary care: study protocol for a parallel-group, two-arm, cluster randomised controlled pilot studyChristopher Ebert0Marie Vogel1Jochen Gensichen2Hanna Reif3Lena Grögor4Lukas Junker5Thomas Ehring6Alkomiet Hasan7Stefan Leucht8Kirsten Lochbühler9for the POKAL-GroupInstitute of General Practice and Family Medicine, University Hospital, LMU MunichInstitute of General Practice and Family Medicine, University Hospital, LMU MunichInstitute of General Practice and Family Medicine, University Hospital, LMU MunichInstitute of General Practice and Family Medicine, University Hospital, LMU MunichInstitute of General Practice and Family Medicine, University Hospital, LMU MunichDepartment Psychology, LMU MunichDZPG (German Center for Mental Health)DZPG (German Center for Mental Health)DZPG (German Center for Mental Health)Institute of General Practice and Family Medicine, University Hospital, LMU MunichAbstract Background General practitioners play an important role in the first-line care of individuals with mental health conditions. However, factors such as time constraints, limited experience in managing mental health conditions and high rates of comorbidity may hinder adequate treatment. To improve psychological care, adopting a transdiagnostic approach shows potential. Research on transdiagnostic interventions delivered by general practitioners is scarce. Thus, a transdiagnostic intervention adapted from the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders was developed specifically for primary care. In a parallel-group, two-arm, cluster randomised controlled pilot study, the transdiagnostic intervention will be evaluated for feasibility, acceptability and potential effectiveness in German primary care. Methods A total of 100 adult patients with a mental health condition will be recruited by general practitioners. In the intervention group, general practitioners will administer the transdiagnostic intervention, introducing patients to psychological concepts based on transdiagnostic factors (i.e., understanding emotions, cognitive flexibility, countering emotion-based avoidance). In the control group, general practitioners will provide improved treatment as usual oriented on official German treatment guidelines for depression, anxiety and somatoform disorders. In both study groups, treatment will be carried out in four 20-min sessions over 12-weeks. Self-report questionnaires will be completed before treatment initiation (only patients) and after treatment completion (patients and general practitioners) to assess feasibility and acceptability (i.e., treatment recruitment, delivery, response, effectiveness, unintended consequences and maintenance) as well as potential effectiveness (i.e., change in transdiagnostic factors). Discussion The pilot study will address the research gap concerning general practitioner-led psychological interventions in primary care and will give insights into whether the adoption of a transdiagnostic approach is of benefit to general practitioners and patients. Findings may inform the design of a main trial by identifying barriers to the transdiagnostic intervention’s feasibility and acceptability, whilst advancing treatment delivery protocols to support effectiveness. Trial registration The protocol for this study has been registered with the German Clinical Trials Register: DRKS00033386, Date of registration: 18th of March 2024, https://drks.de/search/en/trial/DRKS00033386 .https://doi.org/10.1186/s40814-025-01597-6Primary CareFamily MedicineGeneral PractitionerTransdiagnostic approachUnified ProtocolBrief Psychological Intervention |
| spellingShingle | Christopher Ebert Marie Vogel Jochen Gensichen Hanna Reif Lena Grögor Lukas Junker Thomas Ehring Alkomiet Hasan Stefan Leucht Kirsten Lochbühler for the POKAL-Group Evaluation of a transdiagnostic mental health intervention in German primary care: study protocol for a parallel-group, two-arm, cluster randomised controlled pilot study Pilot and Feasibility Studies Primary Care Family Medicine General Practitioner Transdiagnostic approach Unified Protocol Brief Psychological Intervention |
| title | Evaluation of a transdiagnostic mental health intervention in German primary care: study protocol for a parallel-group, two-arm, cluster randomised controlled pilot study |
| title_full | Evaluation of a transdiagnostic mental health intervention in German primary care: study protocol for a parallel-group, two-arm, cluster randomised controlled pilot study |
| title_fullStr | Evaluation of a transdiagnostic mental health intervention in German primary care: study protocol for a parallel-group, two-arm, cluster randomised controlled pilot study |
| title_full_unstemmed | Evaluation of a transdiagnostic mental health intervention in German primary care: study protocol for a parallel-group, two-arm, cluster randomised controlled pilot study |
| title_short | Evaluation of a transdiagnostic mental health intervention in German primary care: study protocol for a parallel-group, two-arm, cluster randomised controlled pilot study |
| title_sort | evaluation of a transdiagnostic mental health intervention in german primary care study protocol for a parallel group two arm cluster randomised controlled pilot study |
| topic | Primary Care Family Medicine General Practitioner Transdiagnostic approach Unified Protocol Brief Psychological Intervention |
| url | https://doi.org/10.1186/s40814-025-01597-6 |
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