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Modified Psychodynamic Psychotherapy for Patients With Schizophrenia (MPP-S)

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
MPP-S
TAU
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizo-affective disorder according to DSM-IV-TR
  • Age 18-64 years
  • Sufficient German language competence
  • Written informed consent
  • Consent to audio recording of psychotherapy sessions and video-taping of assessment interviews at study visits

Exclusion Criteria:

  • Organic brain disorder
  • Relevant somatic disorder impairing cerebral function
  • Relevant abuse alcohol and illegal drugs as assessed by a current or previous indication for treatment for addiction
  • Inability to understand and comply with the requirements of the study and to give written informed consent
  • CDSS-item for suicidal ideation is marked >/= 2
  • Massive agitation or current endangerment of others

Sites / Locations

  • Psychiatrische Universitätsklinik der Charité im St. Hedwig Krankenhaus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MPP-S

standard therapy (TAU)

Arm Description

at least 30 weekly sessions of modified psychodynamic psychotherapy

clinical standard treatment, including supportive therapeutic contacts, pharmacotherapy, creative and occupational therapies, psychoeducation, group therapies, excluding structured individual or group psychotherapy

Outcomes

Primary Outcome Measures

psychosocial functioning
Primary endpoint is the Mini-ICF-APP (=Mini-International Classification of Functioning for limitations of Activities and Participation in Psychological disorders) as a measure of disorders of capacity as defined by the International Classification of Functioning
psychosocial functioning
Primary endpoint is the Mini-ICF-APP (=Mini-International Classification of Functioning for limitations of Activities and Participation in Psychological disorders) as a measure of disorders of capacity as defined by the International Classification of Functioning
psychosocial functioning
Primary endpoint is the Mini-ICF-APP (=Mini-International Classification of Functioning for limitations of Activities and Participation in Psychological disorders) as a measure of disorders of capacity as defined by the International Classification of Functioning
psychosocial functioning
Primary endpoint is the Mini-ICF-APP (=Mini-International Classification of Functioning for limitations of Activities and Participation in Psychological disorders)

Secondary Outcome Measures

psychotic symptom severity
psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS)
psychotic symptom severity
psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS)
psychotic symptom severity
psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS)
psychotic symptom severity
psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS)
depressive symptom severity
depressive symptoms measured by Calgary Depression Scale for Schizophrenia
depressive symptom severity
depressive symptoms measured by Calgary Depression Scale for Schizophrenia
depressive symptom severity
depressive symptoms measured by Calgary Depression Scale for Schizophrenia
depressive symptom severity
depressive symptoms measured by Calgary Depression Scale for Schizophrenia
necessity of hospital treatment
necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year
necessity of hospital treatment
necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year
necessity of hospital treatment
necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year
necessity of hospital treatment
necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year
general symptom severity
Clinical Global Impression (CGI Severity und Improvement)
general symptom severity
Clinical Global Impression (CGI Severity und Improvement)
general symptom severity
Clinical Global Impression (CGI Severity und Improvement)
general symptom severity
Clinical Global Impression (CGI Severity und Improvement)
psychic "structure"
Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD)
psychic "structure"
Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD)
psychic "structure"
Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD)
psychic "structure"
Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD)
metacognitive function
Metacognition Assessment Scale-Abbreviated (MAS-A)
metacognitive function
Metacognition Assessment Scale-Abbreviated (MAS-A)
metacognitive function
Metacognition Assessment Scale-Abbreviated (MAS-A)
metacognitive function
Metacognition Assessment Scale-Abbreviated (MAS-A)
cognitive and emotional mentalization
Movie for the Assessment of Social Cognition (MASC)
cognitive and emotional mentalization
Movie for the Assessment of Social Cognition (MASC)
"mentalized affectivity" and emotional awareness
Levels of Emotional Awareness Scale (LEAS)
"mentalized affectivity" and emotional awareness
Levels of Emotional Awareness Scale (LEAS)
"mentalized affectivity" and emotional awareness
Levels of Emotional Awareness Scale (LEAS)
self-rated ability to solve interpersonal problems
Inventory of Interpersonal Problems (IIP-D)
self-rated ability to solve interpersonal problems
Inventory of Interpersonal Problems (IIP-D)
self-rated ability to solve interpersonal problems
Inventory of Interpersonal Problems (IIP-D)
self-rated ability to solve interpersonal problems
Inventory of Interpersonal Problems (IIP-D)
ability to make subjective sense of psychotic experiences
Questionnaire to assess subjective meaning in psychosis (SuSi)
ability to make subjective sense of psychotic experiences
Questionnaire to assess subjective meaning in psychosis (SuSi)
ability to make subjective sense of psychotic experiences
Questionnaire to assess subjective meaning in psychosis (SuSi)
ability to make subjective sense of psychotic experiences
Questionnaire to assess subjective meaning in psychosis (SuSi)
Changes in cerebral functional activity, connectivity, structure of social cognitive and default-mode networks from Baseline
BOLD-contrast, structure
Changes in cerebral functional activity, connectivity, structure of social cognitive and default-mode networks from Baseline
BOLD-contrast, structure

Full Information

First Posted
October 8, 2015
Last Updated
July 26, 2021
Sponsor
Charite University, Berlin, Germany
Collaborators
International Psychoanalytic University Berlin
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1. Study Identification

Unique Protocol Identification Number
NCT02576613
Brief Title
Modified Psychodynamic Psychotherapy for Patients With Schizophrenia
Acronym
MPP-S
Official Title
Modified Psychodynamic Psychotherapy for Patients With Schizophrenia - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
International Psychoanalytic University Berlin

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A randomized controlled, prospective, two-armed, mono-centric, assessor-blinded clinical trial will serve to generate preliminary data on the efficacy and safety of modified psychodynamic therapy (MPP-S) in stabilized patients after the first or subsequent episodes of schizophrenia or schizoaffective disorder.
Detailed Description
Rationale: Compared to the existing evidence for other psychotherapy methods like cognitive-behavioral psychotherapy or family interventions, the scientific basis of psychodynamic psychotherapy for psychoses is weak with respect to randomized-controlled research. Its encouragement by expert opinion and the broad application of this method stands in sharp contrast to the apparent lack of research interest regarding its efficacy and safety and the fact that more people suffering from schizophrenic spectrum disorders will hopefully embark on psychotherapy in the coming years. The aim of the presented study is therefore on the one hand to explore the efficacy and safety of modified psychodynamic psychotherapy (MPP-S) in a randomized controlled study design. On the other hand, psychodynamic assumptions regarding the treatment of psychotic persons shall be elucidated in an explorative part of the study. For this purpose, a newly developed manual of modified psychodynamic psychotherapy for psychoses will be inaugurated. Primary objective of the study is to determine whether the administration of MPP-S in addition to standard treatment (=treatment as usual: TAU) will lead to an improvement of psychosocial functioning in outpatients with schizophrenia and schizo-affective disorder compared to standard treatment. Secondary objectives refer to the question, whether symptom domains and necessity of hospital treatment, as well as interpersonal functioning and subjective recovery might be impacted by MPP-S compared to TAU alone. Moreover, theoretical assumptions about possible psychodynamic mechanisms of action of MPP-S led to exploratory hypotheses, which are to be tested. Safety and tolerability of the psychodynamic intervention will be evaluated by acquisition of safety data during study visits, but also by continuous monitoring of participants' condition after every treatment session and clinical contact. Additional exploratory objectives of this study deal with the question, whether cerebral functional activity and connectivity within the so-called "Default-Mode-Network" (DMN) measured with fMRI are influenced by psychodynamic psychotherapy in the intervention group compared to the control condition. Moreover, changes of functional correlates of social cognition before and after psychotherapy or TAU will be compared between groups using a video-based social-cognitive task during fMRI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MPP-S
Arm Type
Experimental
Arm Description
at least 30 weekly sessions of modified psychodynamic psychotherapy
Arm Title
standard therapy (TAU)
Arm Type
Experimental
Arm Description
clinical standard treatment, including supportive therapeutic contacts, pharmacotherapy, creative and occupational therapies, psychoeducation, group therapies, excluding structured individual or group psychotherapy
Intervention Type
Other
Intervention Name(s)
MPP-S
Other Intervention Name(s)
Modified psychodynamic psychotherapy
Intervention Description
> 30 weekly sessions of modified psychodynamic psychotherapy in addition to standard treatment
Intervention Type
Other
Intervention Name(s)
TAU
Other Intervention Name(s)
treatment as usual
Intervention Description
standard medical treatment without structured psychotherapeutic intervention
Primary Outcome Measure Information:
Title
psychosocial functioning
Description
Primary endpoint is the Mini-ICF-APP (=Mini-International Classification of Functioning for limitations of Activities and Participation in Psychological disorders) as a measure of disorders of capacity as defined by the International Classification of Functioning
Time Frame
6 months
Title
psychosocial functioning
Description
Primary endpoint is the Mini-ICF-APP (=Mini-International Classification of Functioning for limitations of Activities and Participation in Psychological disorders) as a measure of disorders of capacity as defined by the International Classification of Functioning
Time Frame
12 months
Title
psychosocial functioning
Description
Primary endpoint is the Mini-ICF-APP (=Mini-International Classification of Functioning for limitations of Activities and Participation in Psychological disorders) as a measure of disorders of capacity as defined by the International Classification of Functioning
Time Frame
24 months
Title
psychosocial functioning
Description
Primary endpoint is the Mini-ICF-APP (=Mini-International Classification of Functioning for limitations of Activities and Participation in Psychological disorders)
Time Frame
36 months
Secondary Outcome Measure Information:
Title
psychotic symptom severity
Description
psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS)
Time Frame
6 months
Title
psychotic symptom severity
Description
psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS)
Time Frame
12 months
Title
psychotic symptom severity
Description
psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS)
Time Frame
24 months
Title
psychotic symptom severity
Description
psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS)
Time Frame
36 months
Title
depressive symptom severity
Description
depressive symptoms measured by Calgary Depression Scale for Schizophrenia
Time Frame
6 months
Title
depressive symptom severity
Description
depressive symptoms measured by Calgary Depression Scale for Schizophrenia
Time Frame
12 months
Title
depressive symptom severity
Description
depressive symptoms measured by Calgary Depression Scale for Schizophrenia
Time Frame
24 months
Title
depressive symptom severity
Description
depressive symptoms measured by Calgary Depression Scale for Schizophrenia
Time Frame
36 months
Title
necessity of hospital treatment
Description
necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year
Time Frame
6 months
Title
necessity of hospital treatment
Description
necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year
Time Frame
12 months
Title
necessity of hospital treatment
Description
necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year
Time Frame
24 months
Title
necessity of hospital treatment
Description
necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year
Time Frame
36 months
Title
general symptom severity
Description
Clinical Global Impression (CGI Severity und Improvement)
Time Frame
6 months
Title
general symptom severity
Description
Clinical Global Impression (CGI Severity und Improvement)
Time Frame
12 months
Title
general symptom severity
Description
Clinical Global Impression (CGI Severity und Improvement)
Time Frame
24 months
Title
general symptom severity
Description
Clinical Global Impression (CGI Severity und Improvement)
Time Frame
36 months
Title
psychic "structure"
Description
Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD)
Time Frame
6 months
Title
psychic "structure"
Description
Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD)
Time Frame
12 months
Title
psychic "structure"
Description
Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD)
Time Frame
24 months
Title
psychic "structure"
Description
Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD)
Time Frame
36 months
Title
metacognitive function
Description
Metacognition Assessment Scale-Abbreviated (MAS-A)
Time Frame
6 months
Title
metacognitive function
Description
Metacognition Assessment Scale-Abbreviated (MAS-A)
Time Frame
12 months
Title
metacognitive function
Description
Metacognition Assessment Scale-Abbreviated (MAS-A)
Time Frame
24 months
Title
metacognitive function
Description
Metacognition Assessment Scale-Abbreviated (MAS-A)
Time Frame
36 months
Title
cognitive and emotional mentalization
Description
Movie for the Assessment of Social Cognition (MASC)
Time Frame
baseline
Title
cognitive and emotional mentalization
Description
Movie for the Assessment of Social Cognition (MASC)
Time Frame
12 months
Title
"mentalized affectivity" and emotional awareness
Description
Levels of Emotional Awareness Scale (LEAS)
Time Frame
6 months
Title
"mentalized affectivity" and emotional awareness
Description
Levels of Emotional Awareness Scale (LEAS)
Time Frame
12 months
Title
"mentalized affectivity" and emotional awareness
Description
Levels of Emotional Awareness Scale (LEAS)
Time Frame
24 months
Title
self-rated ability to solve interpersonal problems
Description
Inventory of Interpersonal Problems (IIP-D)
Time Frame
6 months
Title
self-rated ability to solve interpersonal problems
Description
Inventory of Interpersonal Problems (IIP-D)
Time Frame
12 months
Title
self-rated ability to solve interpersonal problems
Description
Inventory of Interpersonal Problems (IIP-D)
Time Frame
24 months
Title
self-rated ability to solve interpersonal problems
Description
Inventory of Interpersonal Problems (IIP-D)
Time Frame
36 months
Title
ability to make subjective sense of psychotic experiences
Description
Questionnaire to assess subjective meaning in psychosis (SuSi)
Time Frame
6 months
Title
ability to make subjective sense of psychotic experiences
Description
Questionnaire to assess subjective meaning in psychosis (SuSi)
Time Frame
12 months
Title
ability to make subjective sense of psychotic experiences
Description
Questionnaire to assess subjective meaning in psychosis (SuSi)
Time Frame
24 months
Title
ability to make subjective sense of psychotic experiences
Description
Questionnaire to assess subjective meaning in psychosis (SuSi)
Time Frame
36 months
Title
Changes in cerebral functional activity, connectivity, structure of social cognitive and default-mode networks from Baseline
Description
BOLD-contrast, structure
Time Frame
baseline
Title
Changes in cerebral functional activity, connectivity, structure of social cognitive and default-mode networks from Baseline
Description
BOLD-contrast, structure
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of schizophrenia or schizo-affective disorder according to DSM-IV-TR Age 18-64 years Sufficient German language competence Written informed consent Consent to audio recording of psychotherapy sessions and video-taping of assessment interviews at study visits Exclusion Criteria: Organic brain disorder Relevant somatic disorder impairing cerebral function Relevant abuse alcohol and illegal drugs as assessed by a current or previous indication for treatment for addiction Inability to understand and comply with the requirements of the study and to give written informed consent CDSS-item for suicidal ideation is marked >/= 2 Massive agitation or current endangerment of others
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christiane Montag, MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatrische Universitätsklinik der Charité im St. Hedwig Krankenhaus
City
Berlin
ZIP/Postal Code
10115
Country
Germany

12. IPD Sharing Statement

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Modified Psychodynamic Psychotherapy for Patients With Schizophrenia

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