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Trial record 2 of 6 for:    psychodynamic therapy | Recruiting, Not yet recruiting, Available Studies

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

This study is currently recruiting participants.
Verified January 2017 by Christiane Montag MD, Charite University, Berlin, Germany
Sponsor:
ClinicalTrials.gov Identifier:
NCT02576613
First Posted: October 15, 2015
Last Update Posted: February 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
International Psychoanalytic University Berlin
Information provided by (Responsible Party):
Christiane Montag MD, Charite University, Berlin, Germany
  Purpose
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.

Condition Intervention
Schizophrenia Schizoaffective Disorder Other: MPP-S Other: TAU

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modified Psychodynamic Psychotherapy for Patients With Schizophrenia - a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Christiane Montag MD, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • psychosocial functioning [ Time Frame: 6 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

  • psychosocial functioning [ Time Frame: 12 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

  • 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


Secondary Outcome Measures:
  • psychotic symptom severity [ Time Frame: 6 months ]
    psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS)

  • psychotic symptom severity [ Time Frame: 12 months ]
    psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS)

  • psychotic symptom severity [ Time Frame: 24 months ]
    psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS)

  • depressive symptom severity [ Time Frame: 6 months ]
    depressive symptoms measured by Calgary Depression Scale for Schizophrenia

  • depressive symptom severity [ Time Frame: 12 months ]
    depressive symptoms measured by Calgary Depression Scale for Schizophrenia

  • depressive symptom severity [ Time Frame: 24 months ]
    depressive symptoms measured by Calgary Depression Scale for Schizophrenia

  • necessity of hospital treatment [ Time Frame: 6 months ]
    necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year

  • necessity of hospital treatment [ Time Frame: 12 months ]
    necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year

  • necessity of hospital treatment [ Time Frame: 24 months ]
    necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year

  • general symptom severity [ Time Frame: 6 months ]
    Clinical Global Impression (CGI Severity und Improvement)

  • general symptom severity [ Time Frame: 12 months ]
    Clinical Global Impression (CGI Severity und Improvement)

  • general symptom severity [ Time Frame: 24 months ]
    Clinical Global Impression (CGI Severity und Improvement)

  • psychic "structure" [ Time Frame: 6 months ]
    Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD)

  • psychic "structure" [ Time Frame: 12 months ]
    Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD)

  • psychic "structure" [ Time Frame: 24 months ]
    Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD)

  • metacognitive function [ Time Frame: 6 months ]
    Metacognition Assessment Scale-Abbreviated (MAS-A)

  • metacognitive function [ Time Frame: 12 months ]
    Metacognition Assessment Scale-Abbreviated (MAS-A)

  • metacognitive function [ Time Frame: 24 months ]
    Metacognition Assessment Scale-Abbreviated (MAS-A)

  • cognitive and emotional mentalization [ Time Frame: 6 months ]
    Movie for the Assessment of Social Cognition (MASC)

  • cognitive and emotional mentalization [ Time Frame: 12 months ]
    Movie for the Assessment of Social Cognition (MASC)

  • cognitive and emotional mentalization [ Time Frame: 24 months ]
    Movie for the Assessment of Social Cognition (MASC)

  • "mentalized affectivity" and emotional awareness [ Time Frame: 6 months ]
    Levels of Emotional Awareness Scale (LEAS)

  • "mentalized affectivity" and emotional awareness [ Time Frame: 12 months ]
    Levels of Emotional Awareness Scale (LEAS)

  • "mentalized affectivity" and emotional awareness [ Time Frame: 24 months ]
    Levels of Emotional Awareness Scale (LEAS)

  • self-rated ability to solve interpersonal problems [ Time Frame: 6 months ]
    Inventory of Interpersonal Problems (IIP-D)

  • self-rated ability to solve interpersonal problems [ Time Frame: 12 months ]
    Inventory of Interpersonal Problems (IIP-D)

  • self-rated ability to solve interpersonal problems [ Time Frame: 24 months ]
    Inventory of Interpersonal Problems (IIP-D)

  • ability to make subjective sense of psychotic experiences [ Time Frame: 6 months ]
    Questionnaire to assess subjective meaning in psychosis (SuSi)

  • ability to make subjective sense of psychotic experiences [ Time Frame: 12 months ]
    Questionnaire to assess subjective meaning in psychosis (SuSi)

  • ability to make subjective sense of psychotic experiences [ Time Frame: 24 months ]
    Questionnaire to assess subjective meaning in psychosis (SuSi)

  • Changes in cerebral functional activity, connectivity, structure of social cognitive and default-mode networks from Baseline [ Time Frame: 12 months ]
    BOLD-contrast, structure

  • Changes in cerebral functional activity, connectivity, structure of social cognitive and default-mode networks from Baseline [ Time Frame: 24 months ]
    BOLD-contrast, structure


Estimated Enrollment: 80
Study Start Date: October 2015
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MPP-S
at least 30 weekly sessions of modified psychodynamic psychotherapy
Other: MPP-S
> 30 weekly sessions of modified psychodynamic psychotherapy in addition to standard treatment
Other Name: Modified psychodynamic psychotherapy
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
Other: TAU
standard medical treatment without structured psychotherapeutic intervention
Other Name: treatment as usual

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576613


Contacts
Contact: Christiane Montag, MD +49 30 2311 2969 christiane.montag@charite.de
Contact: Dorothea von Haebler, Prof. +49 30 300 117-751 dorothea.vonhaebler@ipu-berlin.de

Locations
Germany
Psychiatrische Universitätsklinik der Charité im St. Hedwig Krankenhaus Recruiting
Berlin, Germany, 10115
Contact: Christiane Montag, MD    +49 30 2311 2969    christiane.montag@charite.de   
Contact: Dorothea von Haebler, Prof.    +49 30 450 517196    dorothea.vonhaebler@charite.de   
Principal Investigator: Dorothea von Haebler, Prof.         
Principal Investigator: Günter Lempa, Dr. med.         
Sponsors and Collaborators
Charite University, Berlin, Germany
International Psychoanalytic University Berlin
Investigators
Principal Investigator: Christiane Montag, MD Charite University, Berlin, Germany
  More Information

Responsible Party: Christiane Montag MD, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02576613     History of Changes
Other Study ID Numbers: EA1/200/15
First Submitted: October 8, 2015
First Posted: October 15, 2015
Last Update Posted: February 1, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders