SchizophreniaPROBASNCT04874974
Feasibility of a Novel Process-based Treatment for Patients With Psychosis
A study testing Metacognitive and Defusion Training in people with Schizophrenia and Schizotypal Disorder, run by Max-Planck-Institute of Psychiatry at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia, Schizotypal Disorder, Delusional Disorder
- What is being tested?
- Metacognitive and Defusion Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteGermany
- Study dates
- 10 May 2021to 23 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Schizophrenia, Schizotypal Disorder, Delusional Disorder, Brief Psychotic Disorder, Shared Psychotic Disorder, Schizoaffective Disorder
- Being tested
- Metacognitive and Defusion Training
- Keywords
- Psychosis spectrum disorder, Process-based therapy, Modular psychotherapy, Group Therapy, Acceptance and Commitment Therapy (ACT), Metacognitive Training (MCT)
- Medical subject headings
- Schizophrenia, Schizotypal Personality Disorder, Schizophrenia, Paranoid, Psychotic Disorders, Shared Paranoid Disorder, Mania, Bipolar Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive and Defusion TrainingBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Metacognitive and Defusion Training | Experimental | 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. Receives: Behavioral: Metacognitive and Defusion Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility rate
proportion of those eligible to participate as a percentage of those screened
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: after completing Module III in week 5
Secondary outcomes (7)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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)
Measured: before starting Module III in week 4 and after completing Module II in week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start10 May 2021
- Primary completion10 Mar 2022
- Study completion23 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Max-Planck-Institute of Psychiatry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susanne Lucae, MD, Prof., Principal investigator, Max-Planck-Institute of PsychiatryJohannes M Kopf-Beck, PhD, Principal investigator, Max-Planck-Institute of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874974
- Sponsor's protocol ID
- 21-0025
- Acronym
- PROBAS
- Status last verified
- Oct 2023
- First submitted
- 26 Apr 2021
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33126038Moritz 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.
PubMed 17921766Gaudiano 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.
PubMed 15893293Hayes 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.
PubMed 32932093
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04874974
- Acronym / sponsor ID
- PROBAS / 21-0025
- Conditions
- Schizophrenia, Schizotypal Disorder, Delusional Disorder, Brief Psychotic Disorder, Shared Psychotic Disorder, Schizoaffective Disorder
- Keywords
- Psychosis spectrum disorder, Process-based therapy, Modular psychotherapy, Group Therapy, Acceptance and Commitment Therapy (ACT), Metacognitive Training (MCT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Max-Planck-Institute of PsychiatryUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 23 Sep 2023 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Metacognitive and Defusion Training | Experimental | Behavioral: Metacognitive and Defusion TrainingAll 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metacognitive and Defusion TrainingModule 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). | Behavioural | Metacognitive and Defusion Training |
Primary outcome
Eligibility rate
Time frame: assessed from study start in May 2021 until study completition in May 2022, up to 1 year
proportion of those eligible to participate as a percentage of those screened
Consent rate
Time frame: assessed from study start in May 2021 until study completition in May 2022, up to 1 year
proportion of those who signed the informed consent as a percentage of those who where approached to participate
Trial entry rate
Time frame: assessed from study start in May 2021 until study completition in May 2022, up to 1 year
proportion of those who consented and completed baseline measures
Completion rate
Time frame: assessed from study start in May 2021 until study completition in May 2022, up to 1 year
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
Time frame: assessed from study start in May 2021 until study completition in May 2022, up to 1 year
proportion of missing data for each time point including screening, baseline, intervention and final meeting
Patient engagement
Time frame: assessed from study start in May 2021 until study completition in May 2022, up to 1 year
frequency of unattended sessions per patient as well as the reason for non-attendance
Drop out rate
Time frame: assessed from study start in May 2021 until study completition in May 2022, up to 1 year
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
Time frame: assessed from study start in May 2021 until study completition in May 2022, up to 1 year
number and nature of adverse events
Acceptability of Module I
Time frame: after completion of Module I in week 1
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
Time frame: after completion of Module II in week 3
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
Time frame: after completion of Module III in week 5
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
Time frame: after completing Module III in week 5
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
7 secondary outcomes
Psychopathological in general and positive and negative psychotic symptoms (PANSS)
Time frame: before session 1 in week 1 and after completing the therapy in week 5
Psychopathological in general and positive and negative psychotic symptoms (BPRS)
Time frame: 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)
Time frame: before session 1 in week 1 and after completing the therapy in week 5
Patient's improvement (CGI)
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
Social functioning (WHODAS)
Time frame: in week 1 and week 5
Therapy processes of metacognition (BCIS)
Time frame: before starting Module II in week 2 and after completing Module II in week 3
Degree of Cognitive fusion (CFQ)
Time frame: before starting Module III in week 4 and after completing Module II in week 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Background: PubMed 33126038Barnicot 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.
- Background: PubMed 17921766Moritz 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.
- Background: PubMed 15893293Gaudiano 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.
- Background: PubMed 32932093Hayes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne Lucae, MD, Prof. principal investigator
Max-Planck-Institute of Psychiatry
Johannes M Kopf-Beck, PhD principal investigator
Max-Planck-Institute of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive and Defusion Training in people with Schizophrenia and Schizotypal Disorder, run by Max-Planck-Institute of Psychiatry at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility rate (time frame: assessed from study start in May 2021 until study completition in May 2022, up to 1 year). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04874974, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.