- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02576613
Modified Psychodynamic Psychotherapy for Patients With Schizophrenia (MPP-S)
Modified Psychodynamic Psychotherapy for Patients With Schizophrenia - a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Berlin, Germany, 10115
- Psychiatrische Universitätsklinik der Charité im St. Hedwig Krankenhaus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MPP-S
at least 30 weekly sessions of modified psychodynamic psychotherapy
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> 30 weekly sessions of modified psychodynamic psychotherapy in addition to standard treatment
Other Names:
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Experimental: standard therapy (TAU)
clinical standard treatment, including supportive therapeutic contacts, pharmacotherapy, creative and occupational therapies, psychoeducation, group therapies, excluding structured individual or group psychotherapy
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standard medical treatment without structured psychotherapeutic intervention
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
psychosocial functioning
Time Frame: 6 months
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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
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psychosocial functioning
Time Frame: 12 months
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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
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psychosocial functioning
Time Frame: 24 months
|
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
Time Frame: 36 months
|
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
Time Frame: 6 months
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psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS)
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6 months
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psychotic symptom severity
Time Frame: 12 months
|
psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS)
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12 months
|
psychotic symptom severity
Time Frame: 24 months
|
psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS)
|
24 months
|
psychotic symptom severity
Time Frame: 36 months
|
psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS)
|
36 months
|
depressive symptom severity
Time Frame: 6 months
|
depressive symptoms measured by Calgary Depression Scale for Schizophrenia
|
6 months
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depressive symptom severity
Time Frame: 12 months
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depressive symptoms measured by Calgary Depression Scale for Schizophrenia
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12 months
|
depressive symptom severity
Time Frame: 24 months
|
depressive symptoms measured by Calgary Depression Scale for Schizophrenia
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24 months
|
depressive symptom severity
Time Frame: 36 months
|
depressive symptoms measured by Calgary Depression Scale for Schizophrenia
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36 months
|
necessity of hospital treatment
Time Frame: 6 months
|
necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year
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6 months
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necessity of hospital treatment
Time Frame: 12 months
|
necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year
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12 months
|
necessity of hospital treatment
Time Frame: 24 months
|
necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year
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24 months
|
necessity of hospital treatment
Time Frame: 36 months
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necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year
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36 months
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general symptom severity
Time Frame: 6 months
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Clinical Global Impression (CGI Severity und Improvement)
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6 months
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general symptom severity
Time Frame: 12 months
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Clinical Global Impression (CGI Severity und Improvement)
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12 months
|
general symptom severity
Time Frame: 24 months
|
Clinical Global Impression (CGI Severity und Improvement)
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24 months
|
general symptom severity
Time Frame: 36 months
|
Clinical Global Impression (CGI Severity und Improvement)
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36 months
|
psychic "structure"
Time Frame: 6 months
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Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD)
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6 months
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psychic "structure"
Time Frame: 12 months
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Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD)
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12 months
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psychic "structure"
Time Frame: 24 months
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Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD)
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24 months
|
psychic "structure"
Time Frame: 36 months
|
Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD)
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36 months
|
metacognitive function
Time Frame: 6 months
|
Metacognition Assessment Scale-Abbreviated (MAS-A)
|
6 months
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metacognitive function
Time Frame: 12 months
|
Metacognition Assessment Scale-Abbreviated (MAS-A)
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12 months
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metacognitive function
Time Frame: 24 months
|
Metacognition Assessment Scale-Abbreviated (MAS-A)
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24 months
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metacognitive function
Time Frame: 36 months
|
Metacognition Assessment Scale-Abbreviated (MAS-A)
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36 months
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cognitive and emotional mentalization
Time Frame: baseline
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Movie for the Assessment of Social Cognition (MASC)
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baseline
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cognitive and emotional mentalization
Time Frame: 12 months
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Movie for the Assessment of Social Cognition (MASC)
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12 months
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"mentalized affectivity" and emotional awareness
Time Frame: 6 months
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Levels of Emotional Awareness Scale (LEAS)
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6 months
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"mentalized affectivity" and emotional awareness
Time Frame: 12 months
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Levels of Emotional Awareness Scale (LEAS)
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12 months
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"mentalized affectivity" and emotional awareness
Time Frame: 24 months
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Levels of Emotional Awareness Scale (LEAS)
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24 months
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self-rated ability to solve interpersonal problems
Time Frame: 6 months
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Inventory of Interpersonal Problems (IIP-D)
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6 months
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self-rated ability to solve interpersonal problems
Time Frame: 12 months
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Inventory of Interpersonal Problems (IIP-D)
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12 months
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self-rated ability to solve interpersonal problems
Time Frame: 24 months
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Inventory of Interpersonal Problems (IIP-D)
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24 months
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self-rated ability to solve interpersonal problems
Time Frame: 36 months
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Inventory of Interpersonal Problems (IIP-D)
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36 months
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ability to make subjective sense of psychotic experiences
Time Frame: 6 months
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Questionnaire to assess subjective meaning in psychosis (SuSi)
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6 months
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ability to make subjective sense of psychotic experiences
Time Frame: 12 months
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Questionnaire to assess subjective meaning in psychosis (SuSi)
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12 months
|
ability to make subjective sense of psychotic experiences
Time Frame: 24 months
|
Questionnaire to assess subjective meaning in psychosis (SuSi)
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24 months
|
ability to make subjective sense of psychotic experiences
Time Frame: 36 months
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Questionnaire to assess subjective meaning in psychosis (SuSi)
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36 months
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Changes in cerebral functional activity, connectivity, structure of social cognitive and default-mode networks from Baseline
Time Frame: baseline
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BOLD-contrast, structure
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baseline
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Changes in cerebral functional activity, connectivity, structure of social cognitive and default-mode networks from Baseline
Time Frame: 24 months
|
BOLD-contrast, structure
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24 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Christiane Montag, MD, Charite University, Berlin, Germany
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EA1/200/15
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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