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Completed

NCT Number: NCT02576613

Modified Psychodynamic Psychotherapy for Patients With Schizophrenia

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychiatrische Universitätsklinik der Charité im St. Hedwig Krankenhaus

Berlin, 10115, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MPP-S

Other

> 30 weekly sessions of modified psychodynamic psychotherapy in addition to standard treatment

Other names: Modified psychodynamic psychotherapy

TAU

Other

standard medical treatment without structured psychotherapeutic intervention

Other names: treatment as usual

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

Secondary outcomes

  1. psychotic symptom severity

    Time frame: 6 months

    psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS)

  2. psychotic symptom severity

    Time frame: 12 months

    psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS)

  3. psychotic symptom severity

    Time frame: 24 months

    psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS)

  4. psychotic symptom severity

    Time frame: 36 months

    psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS)

  5. depressive symptom severity

    Time frame: 6 months

    depressive symptoms measured by Calgary Depression Scale for Schizophrenia

  6. depressive symptom severity

    Time frame: 12 months

    depressive symptoms measured by Calgary Depression Scale for Schizophrenia

  7. depressive symptom severity

    Time frame: 24 months

    depressive symptoms measured by Calgary Depression Scale for Schizophrenia

  8. depressive symptom severity

    Time frame: 36 months

    depressive symptoms measured by Calgary Depression Scale for Schizophrenia

  9. necessity of hospital treatment

    Time frame: 6 months

    necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year

  10. necessity of hospital treatment

    Time frame: 12 months

    necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year

  11. necessity of hospital treatment

    Time frame: 24 months

    necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year

  12. necessity of hospital treatment

    Time frame: 36 months

    necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year

  13. general symptom severity

    Time frame: 6 months

    Clinical Global Impression (CGI Severity und Improvement)

  14. general symptom severity

    Time frame: 12 months

    Clinical Global Impression (CGI Severity und Improvement)

  15. general symptom severity

    Time frame: 24 months

    Clinical Global Impression (CGI Severity und Improvement)

  16. general symptom severity

    Time frame: 36 months

    Clinical Global Impression (CGI Severity und Improvement)

  17. psychic "structure"

    Time frame: 6 months

    Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD)

  18. psychic "structure"

    Time frame: 12 months

    Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD)

  19. psychic "structure"

    Time frame: 24 months

    Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD)

  20. psychic "structure"

    Time frame: 36 months

    Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD)

  21. metacognitive function

    Time frame: 6 months

    Metacognition Assessment Scale-Abbreviated (MAS-A)

  22. metacognitive function

    Time frame: 12 months

    Metacognition Assessment Scale-Abbreviated (MAS-A)

  23. metacognitive function

    Time frame: 24 months

    Metacognition Assessment Scale-Abbreviated (MAS-A)

  24. metacognitive function

    Time frame: 36 months

    Metacognition Assessment Scale-Abbreviated (MAS-A)

  25. cognitive and emotional mentalization

    Time frame: baseline

    Movie for the Assessment of Social Cognition (MASC)

  26. cognitive and emotional mentalization

    Time frame: 12 months

    Movie for the Assessment of Social Cognition (MASC)

  27. "mentalized affectivity" and emotional awareness

    Time frame: 6 months

    Levels of Emotional Awareness Scale (LEAS)

  28. "mentalized affectivity" and emotional awareness

    Time frame: 12 months

    Levels of Emotional Awareness Scale (LEAS)

  29. "mentalized affectivity" and emotional awareness

    Time frame: 24 months

    Levels of Emotional Awareness Scale (LEAS)

  30. self-rated ability to solve interpersonal problems

    Time frame: 6 months

    Inventory of Interpersonal Problems (IIP-D)

  31. self-rated ability to solve interpersonal problems

    Time frame: 12 months

    Inventory of Interpersonal Problems (IIP-D)

  32. self-rated ability to solve interpersonal problems

    Time frame: 24 months

    Inventory of Interpersonal Problems (IIP-D)

  33. self-rated ability to solve interpersonal problems

    Time frame: 36 months

    Inventory of Interpersonal Problems (IIP-D)

  34. ability to make subjective sense of psychotic experiences

    Time frame: 6 months

    Questionnaire to assess subjective meaning in psychosis (SuSi)

  35. ability to make subjective sense of psychotic experiences

    Time frame: 12 months

    Questionnaire to assess subjective meaning in psychosis (SuSi)

  36. ability to make subjective sense of psychotic experiences

    Time frame: 24 months

    Questionnaire to assess subjective meaning in psychosis (SuSi)

  37. ability to make subjective sense of psychotic experiences

    Time frame: 36 months

    Questionnaire to assess subjective meaning in psychosis (SuSi)

  38. Changes in cerebral functional activity, connectivity, structure of social cognitive and default-mode networks from Baseline

    Time frame: baseline

    BOLD-contrast, structure

  39. Changes in cerebral functional activity, connectivity, structure of social cognitive and default-mode networks from Baseline

    Time frame: 24 months

    BOLD-contrast, structure

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • International Psychoanalytic University Berlin

Registry information

Official study title

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

Acronym: MPP-S

Important dates

Study start
2015
Primary completion
2021
Study completion
2022
First posted
Oct 15, 2015
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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