An interventional study of Metacognitive and Defusion Training in Schizophrenia, Schizotypal Disorder and Delusional Disorder, sponsored by Max-Planck-Institute of Psychiatry. Completed at 1 site in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Max-Planck-Institute of Psychiatry · Not applicable, Interventional, and Treatment
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.
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.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's enrollment of 37 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Max-Planck-Institute of Psychiatry is the lead sponsor of 19 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
No further constraints will be imposed in order to collect data in a representative clinical sample.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Eligibility rate
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
Consent rate
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
Trial entry rate
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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: after completing Module III in week 5
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)
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)
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
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)
Time frame: 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)
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)
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
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)
Time frame: 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)
Time frame: before starting Module III in week 4 and after completing Module II in week 5
Plan to share: No
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Max-Planck-Institute of Psychiatry