Feasibility of a Novel Process-based Treatment for Patients With Psychosis (PROBAS)

The PROBAS-Study: Developing a Process-based and Modular Group Therapy for Acute Psychiatric Patients With Psychotic Symptoms: a Single-arm Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder; Delusional Disorder; Schizotypal Disorder; Brief Psychotic Disorder; Shared Psychotic 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
• Intervention / Treatment: Behavioral: Metacognitive and Defusion Training

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 80804
      • Max Planck Institute of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Metacognitive and Defusion Training; All participating patients are allocated to the same five-week experimental group therapy, which consists of three different modules (Module I: Psychoeducation on cognitive processes and rational of the therapy - week 1; Module II: Metacognition - week 2+3; Module III: Cognitive Defusion - week 4+5). Group therapy will start with a psychoeducation session of 60 minutes in the first week and will then take place twice a week with each session lasting 60 minutes.

Behavioral: Metacognitive and Defusion Training; Module I will give a brief introduction into the rational of the therapy and explain the terms cognitive biases and relational responding and their role in the development of psychological problems (psychosis) in a simple language and with the help of examples and small exercises. The principle of metacognition and cognitive defusion in psychotherapy will be made clear. An outlook on the procedures and the goals of the group therapy will be given. Module II will include interventions adapted from the MCT manual (Moritz et al., 2017) and Module III with consist of defusion strategies taken from the ACT group manual (Dambacher et al., 2020) and existing studies on ACT and psychosis (Bach et al., 2013; Gaudiano & Herbert, 2006).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eligibility rate	proportion of those eligible to participate as a percentage of those screened	assessed from study start in May 2021 until study completition in May 2022, up to 1 year
Consent rate	proportion of those who signed the informed consent as a percentage of those who where approached to participate	assessed from study start in May 2021 until study completition in May 2022, up to 1 year
Trial entry rate	proportion of those who consented and completed baseline measures	assessed from study start in May 2021 until study completition in May 2022, up to 1 year
Completion rate	proportion of assessments completed at each time point including screening, baseline, intervention and final meeting and reasons for missing data; subjective patient feedback on frequency, duration, delivery, method and content of the assesments	assessed from study start in May 2021 until study completition in May 2022, up to 1 year
Missing data rate	proportion of missing data for each time point including screening, baseline, intervention and final meeting	assessed from study start in May 2021 until study completition in May 2022, up to 1 year
Patient engagement	frequency of unattended sessions per patient as well as the reason for non-attendance	assessed from study start in May 2021 until study completition in May 2022, up to 1 year
Drop out rate	proportion of patients who entered the trial, attended at least one therapy session after baseline but decided to drop out as well as reasons for the drop out	assessed from study start in May 2021 until study completition in May 2022, up to 1 year
Adverse events	number and nature of adverse events	assessed from study start in May 2021 until study completition in May 2022, up to 1 year
Acceptability of Module I	self-rating on subjective effectiveness and acceptability of Module I (one session Psychoeducation). The questionnaire will be designed in a manner similar to session feedback forms developed by Moritz and Woodward (2007) including likert-scaled items on satisfaction, effectiveness, usefulness, applicability and transparency of the aim as well as open-ended feedback	after completion of Module I in week 1
Acceptability of Module II	self-rating on subjective effectiveness and acceptability of Module II (four sessions Metacognition). The questionnaire will be designed in a manner similar to session feedback forms developed by Moritz and Woodward (2007) including likert-scaled items on satisfaction, effectiveness, usefulness, applicability and transparency of the aim as well as open-ended feedback	after completion of Module II in week 3
Acceptability of Module III	self-rating on subjective effectiveness and acceptability of Module III (four sessions Cognitive Defusion). The questionnaire will be designed in a manner similar to session feedback forms developed by Moritz and Woodward (2007) including likert-scaled items on satisfaction, effectiveness, usefulness, applicability and transparency of the aim as well as open-ended feedback	after completion of Module III in week 5
Semi-structured interviews	conducted with one randomly selected patient out of every therapy cycle after completion; selected patients will be asked in detail about feasibility and perceived efficacy of the group program	after completing Module III in week 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychopathological in general and positive and negative psychotic symptoms (PANSS)	assessed with the semi-structured clinical interview Positive and Negative Syndrome Scale (PANSS), the internationally most widely used measure of psychotic symptomatology. The scale ranges from a minimum of 30 (no symptomatology) up to a maximum of 126 (severe symptomatology)	before session 1 in week 1 and after completing the therapy in week 5
Psychopathological in general and positive and negative psychotic symptoms (BPRS)	assessed with the semi-structured clinical interview Brief Psychiatric rating scale (BPRS), next to PANSS the internationally second most used measure of psychotic symptomatology. The scale ranges from a minimum of 18 (no symptomatology) up to 210 (severe symptomatology)	before session 1 in week 1 and after completing the therapy in week 5
Positive symptoms (hallucinatiosn and delusions) and their severity, intensity and frequency (PSYRATS)	measured with the clinical interview Psychotic Symptom Rating Scale (PSYRATS). The subscale auditory hallucinations ranges from a minimum of 0 (no distress) up to a maximum of 44 (high distress), the subscale delusions from a minimum of 0 (no distress) up to a maximum of 24 (high distress)	before session 1 in week 1 and after completing the therapy in week 5
Patient's improvement (CGI)	will be gathered with the Clinical Global Impression Scale (CGI). The Severity scale ranges from a minimum of 1 (not at all ill) up to a maximum of 7 (among the most ill patients) and the Improvement scale from a minimum of 1 (very much improved) up to a maximum of 7 (very much worse)	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
Social functioning (WHODAS)	social functioning will be self-administered by patients through the World Health Organisation Disability Assessment Schedule (WHODAS).	in week 1 and week 5
Therapy processes of metacognition (BCIS)	Beck's Cognitive Insight Scale (BCIS) will be filled in from patients to measure cognitive insight. Scores on the subscale Self-reflectiveness range from a minimum of 0 (high self-reflectiveness) to a maximum of 36 (high self-reflectiveness), scores on the subscale Self-Certainty range from a minimum of 0 (high self-certainty) to a maximum of 24 (low self-certainty)	before starting Module II in week 2 and after completing Module II in week 3
Degree of Cognitive fusion (CFQ)	The Cognitive Fusion Questionnaire (CFQ) will be surveyed from patients to measure the degree of cognitive fusion. The scale ranges from a minimum of 7 (low cognitive fusion) up to a maximum of 49 (high cognitive fusion)	before starting Module III in week 4 and after completing Module II in week 5

Collaborators and Investigators

• Sponsor: Max-Planck-Institute of Psychiatry
• Investigators: Principal Investigator: Susanne Lucae, MD, Prof., Max-Planck-Institute of Psychiatry; Principal Investigator: Johannes M Kopf-Beck, PhD, Max-Planck-Institute of Psychiatry

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Behav Res Ther. 2020 Jan;124:103534.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): March 10, 2022
• Study Completion (Actual): September 23, 2023

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (Actual): May 6, 2021

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Acceptance and Commitment Therapy (ACT); Group Therapy; Psychosis spectrum disorder; Process-based therapy; Modular psychotherapy; Metacognitive Training (MCT)
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Nervous System Diseases; Mood Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Depression; Depressive Disorder; Schizophrenia; Disease; Psychotic Disorders; Mental Disorders; Bipolar Disorder; Depressive Disorder, Major; Mania; Shared Paranoid Disorder; Schizophrenia, Paranoid
• Other Study ID Numbers: 21-0025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No