Modified Psychodynamic Psychotherapy for Patients With Schizophrenia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Modified Psychodynamic Psychotherapy for Patients With Schizophrenia - a Randomized Controlled Trial

Conditions
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Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Other: MPP-S
* Other: TAU


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MPP-S<br>at least 30 weekly sessions of modified psychodynamic psychotherapy | Other: MPP-S<br>* > 30 weekly sessions of modified psychodynamic psychotherapy in addition to standard treatment<br>* Other names: Modified psychodynamic psychotherapy;|
| Experimental: standard therapy (TAU)<br>clinical standard treatment, including supportive therapeutic contacts, pharmacotherapy, creative and occupational therapies, psychoeducation, group therapies, excluding structured individual or group psychotherapy | Other: TAU<br>* standard medical treatment without structured psychotherapeutic intervention<br>* Other names: treatment as usual;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 
| 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 | 12 months | 
| 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 | 24 months | 
| psychosocial functioning | Primary endpoint is the Mini-ICF-APP (=Mini-International Classification of Functioning for limitations of Activities and Participation in Psychological disorders) | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psychotic symptom severity | psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS) | 6 months | 
| psychotic symptom severity | psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS) | 12 months | 
| psychotic symptom severity | psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS) | 24 months | 
| psychotic symptom severity | psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS) | 36 months | 
| depressive symptom severity | depressive symptoms measured by Calgary Depression Scale for Schizophrenia | 6 months | 
| depressive symptom severity | depressive symptoms measured by Calgary Depression Scale for Schizophrenia | 12 months | 
| depressive symptom severity | depressive symptoms measured by Calgary Depression Scale for Schizophrenia | 24 months | 
| depressive symptom severity | depressive symptoms measured by Calgary Depression Scale for Schizophrenia | 36 months | 
| necessity of hospital treatment | necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year | 6 months | 
| necessity of hospital treatment | necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year | 12 months | 
| necessity of hospital treatment | necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year | 24 months | 
| necessity of hospital treatment | necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year | 36 months | 
| general symptom severity | Clinical Global Impression (CGI Severity und Improvement) | 6 months | 
| general symptom severity | Clinical Global Impression (CGI Severity und Improvement) | 12 months | 
| general symptom severity | Clinical Global Impression (CGI Severity und Improvement) | 24 months | 
| general symptom severity | Clinical Global Impression (CGI Severity und Improvement) | 36 months | 
| psychic structure | Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD) | 6 months | 
| psychic structure | Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD) | 12 months | 
| psychic structure | Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD) | 24 months | 
| psychic structure | Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD) | 36 months | 
| metacognitive function | Metacognition Assessment Scale-Abbreviated (MAS-A) | 6 months | 
| metacognitive function | Metacognition Assessment Scale-Abbreviated (MAS-A) | 12 months | 
| metacognitive function | Metacognition Assessment Scale-Abbreviated (MAS-A) | 24 months | 
| metacognitive function | Metacognition Assessment Scale-Abbreviated (MAS-A) | 36 months | 
| cognitive and emotional mentalization | Movie for the Assessment of Social Cognition (MASC) | baseline | 
| cognitive and emotional mentalization | Movie for the Assessment of Social Cognition (MASC) | 12 months | 
| mentalized affectivity and emotional awareness | Levels of Emotional Awareness Scale (LEAS) | 6 months | 
| mentalized affectivity and emotional awareness | Levels of Emotional Awareness Scale (LEAS) | 12 months | 
| mentalized affectivity and emotional awareness | Levels of Emotional Awareness Scale (LEAS) | 24 months | 
| self-rated ability to solve interpersonal problems | Inventory of Interpersonal Problems (IIP-D) | 6 months | 
| self-rated ability to solve interpersonal problems | Inventory of Interpersonal Problems (IIP-D) | 12 months | 
| self-rated ability to solve interpersonal problems | Inventory of Interpersonal Problems (IIP-D) | 24 months | 
| self-rated ability to solve interpersonal problems | Inventory of Interpersonal Problems (IIP-D) | 36 months | 
| ability to make subjective sense of psychotic experiences | Questionnaire to assess subjective meaning in psychosis (SuSi) | 6 months | 
| ability to make subjective sense of psychotic experiences | Questionnaire to assess subjective meaning in psychosis (SuSi) | 12 months | 
| ability to make subjective sense of psychotic experiences | Questionnaire to assess subjective meaning in psychosis (SuSi) | 24 months | 
| ability to make subjective sense of psychotic experiences | Questionnaire to assess subjective meaning in psychosis (SuSi) | 36 months | 
| Changes in cerebral functional activity, connectivity, structure of social cognitive and default-mode networks from Baseline | BOLD-contrast, structure | baseline | 
| Changes in cerebral functional activity, connectivity, structure of social cognitive and default-mode networks from Baseline | BOLD-contrast, structure | 24 months |