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

Primary Purpose

Schizophrenia, Schizotypal Disorder, Delusional Disorder

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Metacognitive and Defusion Training
Sponsored by
Max-Planck-Institute of Psychiatry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Psychosis spectrum disorder, Process-based therapy, Modular psychotherapy, Group Therapy, Acceptance and Commitment Therapy (ACT), Metacognitive Training (MCT)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Max Planck Institute of Psychiatry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metacognitive and Defusion Training

Arm Description

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.

Outcomes

Primary Outcome Measures

Eligibility rate
proportion of those eligible to participate as a percentage of those screened
Consent rate
proportion of those who signed the informed consent as a percentage of those who where approached to participate
Trial entry rate
proportion of those who consented and completed baseline measures
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
Missing data rate
proportion of missing data for each time point including screening, baseline, intervention and final meeting
Patient engagement
frequency of unattended sessions per patient as well as the reason for non-attendance
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
Adverse events
number and nature of adverse events
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
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
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
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

Secondary Outcome Measures

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)
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)
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)
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)
Social functioning (WHODAS)
social functioning will be self-administered by patients through the World Health Organisation Disability Assessment Schedule (WHODAS).
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)
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)

Full Information

First Posted
April 26, 2021
Last Updated
October 19, 2023
Sponsor
Max-Planck-Institute of Psychiatry
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1. Study Identification

Unique Protocol Identification Number
NCT04874974
Brief Title
Feasibility of a Novel Process-based Treatment for Patients With Psychosis
Acronym
PROBAS
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
March 10, 2022 (Actual)
Study Completion Date
September 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Max-Planck-Institute of Psychiatry

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metacognitive and Defusion Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Metacognitive and Defusion Training
Intervention Description
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).
Primary Outcome Measure Information:
Title
Eligibility rate
Description
proportion of those eligible to participate as a percentage of those screened
Time Frame
assessed from study start in May 2021 until study completition in May 2022, up to 1 year
Title
Consent rate
Description
proportion of those who signed the informed consent as a percentage of those who where approached to participate
Time Frame
assessed from study start in May 2021 until study completition in May 2022, up to 1 year
Title
Trial entry rate
Description
proportion of those who consented and completed baseline measures
Time Frame
assessed from study start in May 2021 until study completition in May 2022, up to 1 year
Title
Completion rate
Description
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
Time Frame
assessed from study start in May 2021 until study completition in May 2022, up to 1 year
Title
Missing data rate
Description
proportion of missing data for each time point including screening, baseline, intervention and final meeting
Time Frame
assessed from study start in May 2021 until study completition in May 2022, up to 1 year
Title
Patient engagement
Description
frequency of unattended sessions per patient as well as the reason for non-attendance
Time Frame
assessed from study start in May 2021 until study completition in May 2022, up to 1 year
Title
Drop out rate
Description
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
Time Frame
assessed from study start in May 2021 until study completition in May 2022, up to 1 year
Title
Adverse events
Description
number and nature of adverse events
Time Frame
assessed from study start in May 2021 until study completition in May 2022, up to 1 year
Title
Acceptability of Module I
Description
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
Time Frame
after completion of Module I in week 1
Title
Acceptability of Module II
Description
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
Time Frame
after completion of Module II in week 3
Title
Acceptability of Module III
Description
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
Time Frame
after completion of Module III in week 5
Title
Semi-structured interviews
Description
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
Time Frame
after completing Module III in week 5
Secondary Outcome Measure Information:
Title
Psychopathological in general and positive and negative psychotic symptoms (PANSS)
Description
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)
Time Frame
before session 1 in week 1 and after completing the therapy in week 5
Title
Psychopathological in general and positive and negative psychotic symptoms (BPRS)
Description
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)
Time Frame
before session 1 in week 1 and after completing the therapy in week 5
Title
Positive symptoms (hallucinatiosn and delusions) and their severity, intensity and frequency (PSYRATS)
Description
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)
Time Frame
before session 1 in week 1 and after completing the therapy in week 5
Title
Patient's improvement (CGI)
Description
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)
Time Frame
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
Title
Social functioning (WHODAS)
Description
social functioning will be self-administered by patients through the World Health Organisation Disability Assessment Schedule (WHODAS).
Time Frame
in week 1 and week 5
Title
Therapy processes of metacognition (BCIS)
Description
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)
Time Frame
before starting Module II in week 2 and after completing Module II in week 3
Title
Degree of Cognitive fusion (CFQ)
Description
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)
Time Frame
before starting Module III in week 4 and after completing Module II in week 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Lucae, MD, Prof.
Organizational Affiliation
Max-Planck-Institute of Psychiatry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Johannes M Kopf-Beck, PhD
Organizational Affiliation
Max-Planck-Institute of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Max Planck Institute of Psychiatry
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80804
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33126038
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.
Results Reference
background
PubMed Identifier
17921766
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.
Results Reference
background
PubMed Identifier
15893293
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. Erratum In: Behav Res Ther. 2020 Jan;124:103534.
Results Reference
background
PubMed Identifier
32932093
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.
Results Reference
background

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

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