Modified Psychodynamic Psychotherapy for Patients With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

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.
    

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.
    

Intervention name(s): MPP-S; TAU
Intervention type(s): Other; Other
Intervention description(s): > 30 weekly sessions of modified psychodynamic psychotherapy in addition to standard treatment; standard medical treatment without structured psychotherapeutic intervention
Other intervention name(s): Modified psychodynamic psychotherapy; treatment as usual
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment