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Completed

NCT Number: NCT04874974

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

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.

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Key information

Conditions

Schizophrenia Bipolar Disorder Bipolar Disorder, Current Episode Depressed, Severe, With Psychotic Features Bipolar Disorder, Current Episode Manic Severe With Psychotic Features Bipolar and Related Disorders Brief Psychotic Disorder Delusional Disorder Depressive Disorder Depressive Disorder, Major Disease Attributes Major Depressive Disorder, Recurrent, Severe With Psychotic Symptoms Major Depressive Disorder, Single Episode, Severe With Psychotic Features Mania Manic Episode, Severe With Psychotic Symptoms Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Other Psychotic Disorder Not Due to A Substance or Known Physiological Condition Pathologic Processes Pathological Conditions, Signs and Symptoms Personality Disorders Psychotic Disorders Recurrence Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders Schizophrenia, Paranoid Schizotypal Disorder Schizotypal Personality Disorder Shared Paranoid Disorder Shared Psychotic Disorder Signs and Symptoms Unspecified Psychosis Not Due to a Substance or Known Physiological Condition

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Max Planck Institute of Psychiatry

Munich, Bavaria, 80804, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metacognitive and Defusion Training

Behavioral

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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

Secondary outcomes

  1. 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

    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)

  2. 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

    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)

  3. 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

    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)

  4. 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

    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)

  5. Social functioning (WHODAS)

    Time frame: in week 1 and week 5

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

  6. Therapy processes of metacognition (BCIS)

    Time frame: before starting Module II in week 2 and after completing Module II in week 3

    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)

  7. Degree of Cognitive fusion (CFQ)

    Time frame: before starting Module III in week 4 and after completing Module II in week 5

    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)

Sponsors and collaborators

Lead sponsor

Max-Planck-Institute of Psychiatry

Other

Registry information

Official study title

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

Acronym: PROBAS

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
May 6, 2021
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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