Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04874974
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2021-04-26
Brief Title:
Feasibility of a Novel Process-based Treatment for Patients With Psychosis
Sponsor:
Max-Planck-Institute of Psychiatry
Organization:
Max-Planck-Institute of Psychiatry
Study Overview
Official Title:
The PROBAS-Study Developing a Process-based and Modular Group Therapy for Acute Psychiatric Patients With Psychotic Symptoms a Single-arm Feasibility Study
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROBAS
Brief Summary:
The purpose of this single-arm feasibility study is to develop and pilot test a novel process-based and modular group therapy approach for patients with acute psychotic symptoms in an inpatient setting
Detailed Description:
Due to the enormous economic and social costs of psychotic-spectrum disorders increasing the effectiveness of treatment options has become an important subject for psychiatric research Latest findings in the field of psychotherapy for psychosis show some promising results for so-called Process-based Therapies PBT such as the Metacognitive Training MCT and Acceptance and Commitment Therapy ACT Barnicot et al 2020 Instead of trying to change the content of psychotic symptoms such as hallucinations and delusions PBT directly address cognitive processes which have been found to maintain the disorders symptomatology Hayes et al 2020 While MCT focusses on changing patients cognitive biases by inducing metacognition Moritz Woodward 2007 ACT works with psychological processes such as mindfulness willingness and cognitive distancing Gaudiano Herbert 2006 There is a growing study base for PBT in a psychotic outpatient setting research in non-ambulatory settings though is rare Barnicot et al 2020 Therefore the aim of the current study is to develop and test the feasibility and safety of a new process-based group therapy program for acute psychotic patients The five-week treatment approach will consist of three different modules combining interventions from both MCT and ACT Module I Psychoeducation Module II Metacognition Module III Cognitive Defusion First preliminary effectiveness and process measures PANSS BPRS WHO-DAS CGI BCIS and CFQ will also be included in order to inform the design of future research Thus the study will give valuables insights in the feasibility and effectiveness of an innovative psychotherapy approach and breaks new ground in the field of psychotherapy research for psychosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None