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

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Behavioral: Metacognitive and Defusion Training


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metacognitive and Defusion Training<br>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<br>* 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).<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psychosis spectrum disorder, Process-based therapy, Modular psychotherapy, Group Therapy, Acceptance and Commitment Therapy (ACT), Metacognitive Training (MCT)