Clinical trial NCT04874974: Feasibility of a Novel Process-based Treatment for Patients With Psychosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizotypal Disorder
Delusional Disorder
Brief Psychotic Disorder
Shared Psychotic Disorder
Schizoaffective Disorder
Other Psychotic Disorder Not Due to A Substance or Known Physiological Condition
Unspecified Psychosis Not Due to a Substance or Known Physiological Condition
Manic Episode, Severe With Psychotic Symptoms
Bipolar Disorder, Current Episode Manic Severe With Psychotic Features
Bipolar Disorder, Current Episode Depressed, Severe, With Psychotic Features
Major Depressive Disorder, Single Episode, Severe With Psychotic Features
Major Depressive Disorder, Recurrent, Severe With Psychotic Symptoms
Keywords: Psychosis spectrum disorder
Process-based therapy
Modular psychotherapy
Group Therapy
Acceptance and Commitment Therapy (ACT)
Metacognitive Training (MCT)
Lead sponsor: Max-Planck-Institute of Psychiatry
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Incoming patients from the clinic of Max Planck Institute of Psychiatry are continuously screened for study eligibility and - after they have given informed consent - are assigned to the experimental treatment condition.
Primary purpose: TREATMENT

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 disorder's 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.

Eligibility criteria: Inclusion Criteria:

* Main diagnosis of a mental disorder with psychotic symptoms according to ICD-10 criteria currently experiencing delusions and hallucinations (F20, F21, F22, F23, F24, F25, F28, F29, F30.2, F31.2, F31.5, F32.3, F33.3) indicated by diagnostic assessment of attending MD
* Age between 18 and 70 years
* Informed consent to the study procedures and assessments (in written form)

Exclusion Criteria:

* Severe neurological or internal concomitant diseases
* IQ \< 80; severe learning disability, brain damage or pervasive developmental disorder
* Missing eligibility for psychotherapy because of missing language skills/hostile or uncooperative behaviour.

No further constraints will be imposed in order to collect data in a representative clinical sample.

Primary outcomes:
measure: Eligibility rate
timeFrame: assessed from study start in May 2021 until study completition in May 2022, up to 1 year
measure: Consent rate
timeFrame: assessed from study start in May 2021 until study completition in May 2022, up to 1 year
measure: Trial entry rate
timeFrame: assessed from study start in May 2021 until study completition in May 2022, up to 1 year
measure: Completion rate
timeFrame: assessed from study start in May 2021 until study completition in May 2022, up to 1 year
measure: Missing data rate
timeFrame: assessed from study start in May 2021 until study completition in May 2022, up to 1 year
measure: Patient engagement
timeFrame: assessed from study start in May 2021 until study completition in May 2022, up to 1 year
measure: Drop out rate
timeFrame: assessed from study start in May 2021 until study completition in May 2022, up to 1 year
measure: Adverse events
timeFrame: assessed from study start in May 2021 until study completition in May 2022, up to 1 year
measure: Acceptability of Module I
timeFrame: after completion of Module I in week 1
measure: Acceptability of Module II
timeFrame: after completion of Module II in week 3
measure: Acceptability of Module III
timeFrame: after completion of Module III in week 5
measure: Semi-structured interviews
timeFrame: after completing Module III in week 5
Secondary outcomes:
measure: Psychopathological in general and positive and negative psychotic symptoms (PANSS)
timeFrame: before session 1 in week 1 and after completing the therapy in week 5
measure: Psychopathological in general and positive and negative psychotic symptoms (BPRS)
timeFrame: before session 1 in week 1 and after completing the therapy in week 5
measure: Positive symptoms (hallucinatiosn and delusions) and their severity, intensity and frequency (PSYRATS)
timeFrame: before session 1 in week 1 and after completing the therapy in week 5
measure: Patient's improvement (CGI)
timeFrame: The patient's supervising MD will rate CGI's severity scale for each patient in week 1 and week 5, and the improvement scale only after week 5
measure: Social functioning (WHODAS)
timeFrame: in week 1 and week 5
measure: Therapy processes of metacognition (BCIS)
timeFrame: before starting Module II in week 2 and after completing Module II in week 3
measure: Degree of Cognitive fusion (CFQ)
timeFrame: before starting Module III in week 4 and after completing Module II in week 5
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Max Planck Institute of Psychiatry
state: Bavaria
Study officials:
affiliation: Max-Planck-Institute of Psychiatry
name: Susanne Lucae, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Max-Planck-Institute of Psychiatry
name: Johannes M Kopf-Beck, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barnicot K, Michael C, Trione E, Lang S, Saunders T, Sharp M, Crawford MJ. Psychological interventions for acute psychiatric inpatients with schizophrenia-spectrum disorders: A systematic review and meta-analysis. Clin Psychol Rev. 2020 Dec;82:101929. doi: 10.1016/j.cpr.2020.101929. Epub 2020 Oct 17.
citation: Moritz S, Woodward TS. Metacognitive training in schizophrenia: from basic research to knowledge translation and intervention. Curr Opin Psychiatry. 2007 Nov;20(6):619-25. doi: 10.1097/YCO.0b013e3282f0b8ed.
citation: Gaudiano BA, Herbert JD. Acute treatment of inpatients with psychotic symptoms using Acceptance and Commitment Therapy: pilot results. Behav Res Ther. 2006 Mar;44(3):415-37. doi: 10.1016/j.brat.2005.02.007.
citation: Hayes SC, Hofmann SG, Ciarrochi J. A process-based approach to psychological diagnosis and treatment:The conceptual and treatment utility of an extended evolutionary meta model. Clin Psychol Rev. 2020 Dec;82:101908. doi: 10.1016/j.cpr.2020.101908. Epub 2020 Sep 7.