Modified Psychodynamic Psychotherapy for Patients With Schizophrenia
- Conditions
- SchizophreniaSchizoaffective Disorder
- Interventions
- Other: MPP-SOther: TAU
- Registration Number
- NCT02576613
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MPP-S MPP-S at least 30 weekly sessions of modified psychodynamic psychotherapy standard therapy (TAU) TAU clinical standard treatment, including supportive therapeutic contacts, pharmacotherapy, creative and occupational therapies, psychoeducation, group therapies, excluding structured individual or group psychotherapy
- Primary Outcome Measures
Name Time Method psychosocial functioning 36 months Primary endpoint is the Mini-ICF-APP (=Mini-International Classification of Functioning for limitations of Activities and Participation in Psychological disorders)
- Secondary Outcome Measures
Name Time Method self-rated ability to solve interpersonal problems 36 months Inventory of Interpersonal Problems (IIP-D)
general symptom severity 36 months Clinical Global Impression (CGI Severity und Improvement)
psychotic symptom severity 36 months psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS)
metacognitive function 36 months Metacognition Assessment Scale-Abbreviated (MAS-A)
depressive symptom severity 36 months depressive symptoms measured by Calgary Depression Scale for Schizophrenia
cognitive and emotional mentalization 12 months Movie for the Assessment of Social Cognition (MASC)
Changes in cerebral functional activity, connectivity, structure of social cognitive and default-mode networks from Baseline 24 months BOLD-contrast, structure
necessity of hospital treatment 36 months necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year
psychic "structure" 36 months Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD)
"mentalized affectivity" and emotional awareness 24 months Levels of Emotional Awareness Scale (LEAS)
ability to make subjective sense of psychotic experiences 36 months Questionnaire to assess subjective meaning in psychosis (SuSi)
Trial Locations
- Locations (1)
Psychiatrische Universitätsklinik der Charité im St. Hedwig Krankenhaus
🇩🇪Berlin, Germany