Clinical trial NCT02576613: Modified Psychodynamic Psychotherapy for Patients With Schizophrenia
Official title: Modified Psychodynamic Psychotherapy for Patients With Schizophrenia - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: International Psychoanalytic University Berlin
First posted: 2015-10-15
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: psychosocial functioning
timeFrame: 6 months
measure: psychosocial functioning
timeFrame: 12 months
measure: psychosocial functioning
timeFrame: 24 months
measure: psychosocial functioning
timeFrame: 36 months
Secondary outcomes:
measure: psychotic symptom severity
timeFrame: 6 months
measure: psychotic symptom severity
timeFrame: 12 months
measure: psychotic symptom severity
timeFrame: 24 months
measure: psychotic symptom severity
timeFrame: 36 months
measure: depressive symptom severity
timeFrame: 6 months
measure: depressive symptom severity
timeFrame: 12 months
measure: depressive symptom severity
timeFrame: 24 months
measure: depressive symptom severity
timeFrame: 36 months
measure: necessity of hospital treatment
timeFrame: 6 months
measure: necessity of hospital treatment
timeFrame: 12 months
measure: necessity of hospital treatment
timeFrame: 24 months
measure: necessity of hospital treatment
timeFrame: 36 months
measure: general symptom severity
timeFrame: 6 months
measure: general symptom severity
timeFrame: 12 months
measure: general symptom severity
timeFrame: 24 months
measure: general symptom severity
timeFrame: 36 months
measure: psychic "structure"
timeFrame: 6 months
measure: psychic "structure"
timeFrame: 12 months
measure: psychic "structure"
timeFrame: 24 months
measure: psychic "structure"
timeFrame: 36 months
measure: metacognitive function
timeFrame: 6 months
measure: metacognitive function
timeFrame: 12 months
measure: metacognitive function
timeFrame: 24 months
measure: metacognitive function
timeFrame: 36 months
measure: cognitive and emotional mentalization
timeFrame: baseline
measure: cognitive and emotional mentalization
timeFrame: 12 months
measure: "mentalized affectivity" and emotional awareness
timeFrame: 6 months
measure: "mentalized affectivity" and emotional awareness
timeFrame: 12 months
measure: "mentalized affectivity" and emotional awareness
timeFrame: 24 months
measure: self-rated ability to solve interpersonal problems
timeFrame: 6 months
measure: self-rated ability to solve interpersonal problems
timeFrame: 12 months
measure: self-rated ability to solve interpersonal problems
timeFrame: 24 months
measure: self-rated ability to solve interpersonal problems
timeFrame: 36 months
measure: ability to make subjective sense of psychotic experiences
timeFrame: 6 months
measure: ability to make subjective sense of psychotic experiences
timeFrame: 12 months
measure: ability to make subjective sense of psychotic experiences
timeFrame: 24 months
measure: ability to make subjective sense of psychotic experiences
timeFrame: 36 months
measure: Changes in cerebral functional activity, connectivity, structure of social cognitive and default-mode networks from Baseline
timeFrame: baseline
measure: Changes in cerebral functional activity, connectivity, structure of social cognitive and default-mode networks from Baseline
timeFrame: 24 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Psychiatrische Universitätsklinik der Charité im St. Hedwig Krankenhaus
Study officials:
affiliation: Charite University, Berlin, Germany
name: Christiane Montag, MD
role: PRINCIPAL_INVESTIGATOR
References: