SchizophreniaKUSSNCT01622166
Art Therapy in Acute Schizophrenia
A study testing psychodynamic art therapy in people with Schizophrenia, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Randomised, controlled, single-blinded pilot study to assess the efficacy of psychodynamic art therapy in a sample of hospitalized, (sub)acutely psychotic patients with a diagnosis of schizophrenia compared to a group of patients receiving treatment as usual. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- psychodynamic art therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Jan 2013
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis of schizophrenia according to DSM-IV-TR
- age 18-64 yrs
- sufficient German language competency
- written informed consent
Who cannot join
- axis-I mental disorders other than schizophrenia
- comorbid antisocial personality disorder, relevant substance abuse,
- relevant severe somatic disease
- acute suicidal tendencies or aggression
- incapability to tolerate group settings
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: Art Therapy for Symptom Reduction in Acute Schizophrenia - a Randomised Controlled Trial (Kunsttherapie Zur Symptomreduktion Bei Akuter Schizophrenie - Eine Randomisierte Kontrollierte Pilotstudie)
Randomised, controlled, single-blinded pilot study to assess the efficacy of psychodynamic art therapy in a sample of hospitalized, (sub)acutely psychotic patients with a diagnosis of schizophrenia compared to a group of patients receiving treatment as usual.
*Main hypothesis: Art therapy has no impact on clinical symptoms and the course of remission compared to TAU.
*Exploratory hypotheses: Art therapy has no influence on quality of life, mentalizing function, self-efficacy and neuroleptic dosage compared to TAU.
- Conditions
- Schizophrenia
- Being tested
- psychodynamic art therapy
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychodynamic art therapyBehavioural
2 sessions à 1.5 hrs /week, intervention duration 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| art therapy | Experimental | 12 sessions of art therapy / 6 weeks Receives: Behavioral: psychodynamic art therapy |
| TAU | No intervention | treatment as usual / 6 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Positive and Negative Syndrome Scale (PANSS-) scores
assessment of change of schizophrenic positive, negative and general symptom scores
Measured: weeks 0, 6, 12
safety measures
number of participants with adverse events
Measured: weeks 0, 6, 12
Change in Calgary depression Scale (CDS-) scores
assessment of change of depressive symptoms in schizophrenic patients as reflected by CDS-scores
Measured: weeks 0, 6, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startAug 2011
- Primary completionJan 2013
- Study completionJan 2013
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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. K. Dannecker, Kunsttherapie Berlin Kunsthochschule Berlin-Weißensee
- Responsible party
- Principal investigator, Christiane Montag MD, Charite University, Berlin, Germany
- Investigators
- Christiane Montag, M.D., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622166
- Sponsor's protocol ID
- EA1/104/11
- Acronym
- KUSS
- Status last verified
- Oct 2014
- First submitted
- 12 Jun 2012
- Last updated
- 24 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Montag C, Haase L, Seidel D, Bayerl M, Gallinat J, Herrmann U, Dannecker K. A pilot RCT of psychodynamic group art therapy for patients in acute psychotic episodes: feasibility, impact on symptoms and mentalising capacity. PLoS One. 2014 Nov 13;9(11):e112348. doi: 10.1371/journal.pone.0112348. eCollection 2014.
PubMed 25393414
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Art Therapy for Symptom Reduction in Acute Schizophrenia - a Randomised Controlled Trial (Kunsttherapie Zur Symptomreduktion Bei Akuter Schizophrenie - Eine Randomisierte Kontrollierte Pilotstudie)
- ClinicalTrials.gov ID
- NCT01622166
- Acronym / sponsor ID
- KUSS / EA1/104/11
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Prof. K. Dannecker, Kunsttherapie Berlin Kunsthochschule Berlin-Weißensee
- Study start
- Aug 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 19 Jun 2012 (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.
Randomised, controlled, single-blinded pilot study to assess the efficacy of psychodynamic art therapy in a sample of hospitalized, (sub)acutely psychotic patients with a diagnosis of schizophrenia compared to a group of patients receiving treatment as usual.
*Main hypothesis: Art therapy has no impact on clinical symptoms and the course of remission compared to TAU.
*Exploratory hypotheses: Art therapy has no influence on quality of life, mentalizing function, self-efficacy and neuroleptic dosage compared to TAU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| art therapy | Experimental | Behavioral: psychodynamic art therapy12 sessions of art therapy / 6 weeks |
| TAU | No intervention | –treatment as usual / 6 weeks |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- diagnosis of schizophrenia according to DSM-IV-TR
- age 18-64 yrs
- sufficient German language competency
- written informed consent
Key exclusion criteria (5 listed)
- axis-I mental disorders other than schizophrenia
- comorbid antisocial personality disorder, relevant substance abuse,
- relevant severe somatic disease
- acute suicidal tendencies or aggression
- incapability to tolerate group settings
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 |
|---|---|---|
| psychodynamic art therapy2 sessions à 1.5 hrs /week, intervention duration 6 weeks | Behavioural | art therapy |
Primary outcome
Change in Positive and Negative Syndrome Scale (PANSS-) scores
Time frame: weeks 0, 6, 12
assessment of change of schizophrenic positive, negative and general symptom scores
safety measures
Time frame: weeks 0, 6, 12
number of participants with adverse events
Change in Calgary depression Scale (CDS-) scores
Time frame: weeks 0, 6, 12
assessment of change of depressive symptoms in schizophrenic patients as reflected by CDS-scores
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 24 Oct 2014.
- Derived from this study: PubMed 25393414Montag C, Haase L, Seidel D, Bayerl M, Gallinat J, Herrmann U, Dannecker K. A pilot RCT of psychodynamic group art therapy for patients in acute psychotic episodes: feasibility, impact on symptoms and mentalising capacity. PLoS One. 2014 Nov 13;9(11):e112348. doi: 10.1371/journal.pone.0112348. eCollection 2014.
- Related InfoLink provided by the sponsor.
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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, M.D. 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 psychodynamic art therapy in people with Schizophrenia, 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 4 inclusion and 5 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 24 Oct 2014. 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?
Change in Positive and Negative Syndrome Scale (PANSS-) scores (time frame: weeks 0, 6, 12). The study lists 3 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 NCT01622166, 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 24 Oct 2014.