Modified Psychodynamic Psychotherapy for Patients With Schizophrenia

Schizophrenia Clinical Trial

— MPP-S  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02576613
• Other study ID #: EA1/200/15
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: December 2022

Study information

• Verified date: February 2024
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Other:
• MPP-S
> 30 weekly sessions of modified psychodynamic psychotherapy in addition to standard treatment
• TAU
standard medical treatment without structured psychotherapeutic intervention

Locations

Country	Name	City	State
Germany	Psychiatrische Universitätsklinik der Charité im St. Hedwig Krankenhaus	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	International Psychoanalytic University Berlin

Country where clinical trial is conducted

Germany, 

Outcome

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