Modified Psychodynamic Psychotherapy for Patients With Schizophrenia

NCT ID: NCT02576613

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2022-12-31

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MPP-S

at least 30 weekly sessions of modified psychodynamic psychotherapy

Group Type: EXPERIMENTAL

MPP-S

Intervention Type: OTHER

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

standard therapy (TAU)

clinical standard treatment, including supportive therapeutic contacts, pharmacotherapy, creative and occupational therapies, psychoeducation, group therapies, excluding structured individual or group psychotherapy

Group Type: EXPERIMENTAL

TAU

Intervention Type: OTHER

standard medical treatment without structured psychotherapeutic intervention

Interventions

MPP-S

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

Intervention Type: OTHER

TAU

standard medical treatment without structured psychotherapeutic intervention

Intervention Type: OTHER

Other Intervention Names

Modified psychodynamic psychotherapy; treatment as usual

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Psychoanalytic University Berlin

OTHER

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Christiane Montag MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christiane Montag, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Psychiatrische Universitätsklinik der Charité im St. Hedwig Krankenhaus

Berlin, , Germany

Countries

Germany

Other Identifiers

EA1/200/15

Identifier Type: -

Identifier Source: org_study_id