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

NCT04874974 | Completed

• 1 other identifier: 21-0025
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

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

Keywords

Psychosis spectrum disorder; Process-based therapy; Modular psychotherapy; Group Therapy; Acceptance and Commitment Therapy (ACT); Metacognitive Training (MCT)

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (7)

• Psychopathological in general and positive and negative psychotic symptoms (PANSS)

  before session 1 in week 1 and after completing the therapy in week 5

• Psychopathological in general and positive and negative psychotic symptoms (BPRS)

  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)

  before session 1 in week 1 and after completing the therapy in week 5

• Patient's improvement (CGI)

  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)

  in week 1 and week 5

Study Arms (1)

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.

Behavioral: Metacognitive and Defusion Training

Interventions

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).

Metacognitive and Defusion Training

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Max-Planck-Institute of Psychiatry: lead

Study Sites (1)

Max Planck Institute of Psychiatry

Munich, Bavaria, 80804, Germany

Location

Related Publications (4)

• 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.

  PMID: 33126038 BACKGROUND

• 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.

  PMID: 17921766 BACKGROUND

• 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.

  PMID: 15893293 BACKGROUND

• 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.

  PMID: 32932093 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Schizotypal Personality Disorder; Schizophrenia, Paranoid; Psychotic Disorders; Shared Paranoid Disorder; Mania; Bipolar Disorder; Depressive Disorder, Major; Recurrence

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Personality Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bipolar and Related Disorders; Mood Disorders; Depressive Disorder; Disease Attributes; Pathologic Processes

Study Officials

• Susanne Lucae, MD, Prof.

  Max-Planck-Institute of Psychiatry

  PRINCIPAL INVESTIGATOR

• Johannes M Kopf-Beck, PhD

  Max-Planck-Institute of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 6, 2021
• Study Start: May 10, 2021
• Primary Completion: March 10, 2022
• Study Completion: September 23, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)