SchizophreniaMPP-SNCT02576613
Modified Psychodynamic Psychotherapy for Patients With Schizophrenia
A study testing MPP-S and TAU in people with Schizophrenia and Schizoaffective Disorder, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- MPP-S and TAU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2015to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Psychiatrische Universitätsklinik der Charité im St. Hedwig Krankenhaus
Berlin, 10115
About this study
Official title: Modified Psychodynamic Psychotherapy for Patients With Schizophrenia - a Randomized Controlled Trial
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.
Read the 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
- Being tested
- MPP-S, TAU
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPP-SOther
Also called Modified psychodynamic psychotherapy
> 30 weekly sessions of modified psychodynamic psychotherapy in addition to standard treatment
TAUOther
Also called treatment as usual
standard medical treatment without structured psychotherapeutic intervention
| Study group | Role | What they receive |
|---|---|---|
| MPP-S | Experimental | at least 30 weekly sessions of modified psychodynamic psychotherapy Receives: Other: MPP-S |
| standard therapy (TAU) | Experimental | clinical standard treatment, including supportive therapeutic contacts, pharmacotherapy, creative and occupational therapies, psychoeducation, group therapies, excluding structured individual or group psychotherapy Receives: Other: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
psychosocial functioning
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
Measured: 6 months
psychosocial functioning
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
Measured: 12 months
psychosocial functioning
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
Measured: 24 months
psychosocial functioning
Primary endpoint is the Mini-ICF-APP (=Mini-International Classification of Functioning for limitations of Activities and Participation in Psychological disorders)
Measured: 36 months
Secondary outcomes (39)
psychotic symptom severity
psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS)
Measured: 6 months
psychotic symptom severity
psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS)
Measured: 12 months
psychotic symptom severity
psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS)
Measured: 24 months
psychotic symptom severity
psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS)
Measured: 36 months
depressive symptom severity
depressive symptoms measured by Calgary Depression Scale for Schizophrenia
Measured: 6 months
depressive symptom severity
depressive symptoms measured by Calgary Depression Scale for Schizophrenia
Measured: 12 months
depressive symptom severity
depressive symptoms measured by Calgary Depression Scale for Schizophrenia
Measured: 24 months
depressive symptom severity
depressive symptoms measured by Calgary Depression Scale for Schizophrenia
Measured: 36 months
necessity of hospital treatment
necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year
Measured: 6 months
necessity of hospital treatment
necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year
Measured: 12 months
necessity of hospital treatment
necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year
Measured: 24 months
necessity of hospital treatment
necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year
Measured: 36 months
general symptom severity
Clinical Global Impression (CGI Severity und Improvement)
Measured: 6 months
general symptom severity
Clinical Global Impression (CGI Severity und Improvement)
Measured: 12 months
general symptom severity
Clinical Global Impression (CGI Severity und Improvement)
Measured: 24 months
general symptom severity
Clinical Global Impression (CGI Severity und Improvement)
Measured: 36 months
psychic "structure"
Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD)
Measured: 6 months
psychic "structure"
Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD)
Measured: 12 months
psychic "structure"
Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD)
Measured: 24 months
psychic "structure"
Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD)
Measured: 36 months
metacognitive function
Metacognition Assessment Scale-Abbreviated (MAS-A)
Measured: 6 months
metacognitive function
Metacognition Assessment Scale-Abbreviated (MAS-A)
Measured: 12 months
metacognitive function
Metacognition Assessment Scale-Abbreviated (MAS-A)
Measured: 24 months
metacognitive function
Metacognition Assessment Scale-Abbreviated (MAS-A)
Measured: 36 months
cognitive and emotional mentalization
Movie for the Assessment of Social Cognition (MASC)
Measured: baseline
cognitive and emotional mentalization
Movie for the Assessment of Social Cognition (MASC)
Measured: 12 months
"mentalized affectivity" and emotional awareness
Levels of Emotional Awareness Scale (LEAS)
Measured: 6 months
"mentalized affectivity" and emotional awareness
Levels of Emotional Awareness Scale (LEAS)
Measured: 12 months
"mentalized affectivity" and emotional awareness
Levels of Emotional Awareness Scale (LEAS)
Measured: 24 months
self-rated ability to solve interpersonal problems
Inventory of Interpersonal Problems (IIP-D)
Measured: 6 months
self-rated ability to solve interpersonal problems
Inventory of Interpersonal Problems (IIP-D)
Measured: 12 months
self-rated ability to solve interpersonal problems
Inventory of Interpersonal Problems (IIP-D)
Measured: 24 months
self-rated ability to solve interpersonal problems
Inventory of Interpersonal Problems (IIP-D)
Measured: 36 months
ability to make subjective sense of psychotic experiences
Questionnaire to assess subjective meaning in psychosis (SuSi)
Measured: 6 months
ability to make subjective sense of psychotic experiences
Questionnaire to assess subjective meaning in psychosis (SuSi)
Measured: 12 months
ability to make subjective sense of psychotic experiences
Questionnaire to assess subjective meaning in psychosis (SuSi)
Measured: 24 months
ability to make subjective sense of psychotic experiences
Questionnaire to assess subjective meaning in psychosis (SuSi)
Measured: 36 months
Changes in cerebral functional activity, connectivity, structure of social cognitive and default-mode networks from Baseline
BOLD-contrast, structure
Measured: baseline
Changes in cerebral functional activity, connectivity, structure of social cognitive and default-mode networks from Baseline
BOLD-contrast, structure
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2021
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- International Psychoanalytic University Berlin
- Responsible party
- Principal investigator, Christiane Montag MD, Charite University, Berlin, Germany
- Investigators
- Christiane Montag, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576613
- Sponsor's protocol ID
- EA1/200/15
- Acronym
- MPP-S
- Status last verified
- Feb 2024
- First submitted
- 8 Oct 2015
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Montag C, Brocker AL, Bayer S, Becker K, Bertram G, Buttner M, Funcke J, Grimm I, Just SA, Hadzibegovic J, Maassen E, Nenchev I, Stuke F, Bermpohl F, Heinz A, Lempa G, von Haebler D. The efficacy of modified psychodynamic psychotherapy for patients with schizophrenia-spectrum disorders in Germany: a prospective, single-centre, assessor-blinded, parallel-group, randomised controlled trial. Lancet Psychiatry. 2026 Oct;13(10):870-883. doi: 10.1016/S2215-0366(26)00240-3.
PubMed 42716057
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Psychodynamic Psychotherapy for Patients With Schizophrenia - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02576613
- Acronym / sponsor ID
- MPP-S / EA1/200/15
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- International Psychoanalytic University Berlin
- Study start
- Oct 2015
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 15 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPP-S | Experimental | Other: MPP-Sat least 30 weekly sessions of modified psychodynamic psychotherapy |
| standard therapy (TAU) | Experimental | Other: TAUclinical standard treatment, including supportive therapeutic contacts, pharmacotherapy, creative and occupational therapies, psychoeducation, group therapies, excluding structured individual or group psychotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MPP-SAlso: Modified psychodynamic psychotherapy> 30 weekly sessions of modified psychodynamic psychotherapy in addition to standard treatment | Other | MPP-S |
| TAUAlso: treatment as usualstandard medical treatment without structured psychotherapeutic intervention | Other | standard therapy (TAU) |
Primary outcome
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
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
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
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)
39 secondary outcomes
psychotic symptom severity
Time frame: 6 months
psychotic symptom severity
Time frame: 12 months
psychotic symptom severity
Time frame: 24 months
psychotic symptom severity
Time frame: 36 months
depressive symptom severity
Time frame: 6 months
depressive symptom severity
Time frame: 12 months
depressive symptom severity
Time frame: 24 months
depressive symptom severity
Time frame: 36 months
necessity of hospital treatment
Time frame: 6 months
necessity of hospital treatment
Time frame: 12 months
necessity of hospital treatment
Time frame: 24 months
necessity of hospital treatment
Time frame: 36 months
general symptom severity
Time frame: 6 months
general symptom severity
Time frame: 12 months
general symptom severity
Time frame: 24 months
general symptom severity
Time frame: 36 months
psychic "structure"
Time frame: 6 months
psychic "structure"
Time frame: 12 months
psychic "structure"
Time frame: 24 months
psychic "structure"
Time frame: 36 months
metacognitive function
Time frame: 6 months
metacognitive function
Time frame: 12 months
metacognitive function
Time frame: 24 months
metacognitive function
Time frame: 36 months
cognitive and emotional mentalization
Time frame: baseline
cognitive and emotional mentalization
Time frame: 12 months
"mentalized affectivity" and emotional awareness
Time frame: 6 months
"mentalized affectivity" and emotional awareness
Time frame: 12 months
"mentalized affectivity" and emotional awareness
Time frame: 24 months
self-rated ability to solve interpersonal problems
Time frame: 6 months
self-rated ability to solve interpersonal problems
Time frame: 12 months
self-rated ability to solve interpersonal problems
Time frame: 24 months
self-rated ability to solve interpersonal problems
Time frame: 36 months
ability to make subjective sense of psychotic experiences
Time frame: 6 months
ability to make subjective sense of psychotic experiences
Time frame: 12 months
ability to make subjective sense of psychotic experiences
Time frame: 24 months
ability to make subjective sense of psychotic experiences
Time frame: 36 months
Changes in cerebral functional activity, connectivity, structure of social cognitive and default-mode networks from Baseline
Time frame: baseline
Changes in cerebral functional activity, connectivity, structure of social cognitive and default-mode networks from Baseline
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Derived from this study: PubMed 42716057Montag C, Brocker AL, Bayer S, Becker K, Bertram G, Buttner M, Funcke J, Grimm I, Just SA, Hadzibegovic J, Maassen E, Nenchev I, Stuke F, Bermpohl F, Heinz A, Lempa G, von Haebler D. The efficacy of modified psychodynamic psychotherapy for patients with schizophrenia-spectrum disorders in Germany: a prospective, single-centre, assessor-blinded, parallel-group, randomised controlled trial. Lancet Psychiatry. 2026 Oct;13(10):870-883. doi: 10.1016/S2215-0366(26)00240-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christiane Montag, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MPP-S and TAU in people with Schizophrenia and Schizoaffective Disorder, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
psychosocial functioning (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02576613, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.