SchizophreniaNCT02383095
Efficiency of Art-therapy in Psychotic Disorders
A study testing Art therapy and metacognitive therapy in people with Schizophrenia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The main purpose of the protocol is to test the efficiency of art-therapy versus metacognitive rehabilitation on the visual perception disorders observed in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Art therapy and metacognitive therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 27 May 2015to Oct 2019
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- schizophrenia according to DSM IV
Who cannot join
- addiction problem
- invalidating visual sensory problems
- neurological history
Trial locations and contacts
1 site in 1 country.
France1 site
Service de psychiatrie, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
The main purpose of the protocol is to test the efficiency of art-therapy versus metacognitive rehabilitation on the visual perception disorders observed in patients with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- Art therapy, metacognitive therapy
- Keywords
- Schizophrenia, Art-therapy, Visual organization
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art therapyBehavioural
metacognitive therapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Art-therapy | Experimental | 16 Art-therapy sessions Receives: Behavioral: Art therapy |
| Metacognitive therapy | Active comparator | 16 Metacognitive therapy sessions Receives: Behavioral: metacognitive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Response times between baseline and after 16 therapy sessions
Measured: Baseline and after 16 therapy sessions (up to 6 months)
Secondary outcomes (3)
Change in Clinical scales (SAPS and SANS) between baseline and after 16 therapy sessions
Measured: Baseline and after 16 therapy sessions (up to 6 months)
Change in esthetic perception between baseline and after 16 therapy sessions
Esthetic Perception Test
Measured: Baseline and after 16 therapy sessions (up to 6 months)
Change in errors in visual organization tasks between baseline and after 16 therapy sessions
Measured: aseline and after 16 therapy sessions (up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study start27 May 2015
- Primary completionOct 2019
- Study completionOct 2019
Why it stopped: Difficulties of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne GIERSCH, PhD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383095
- Sponsor's protocol ID
- 5937
- Status last verified
- Oct 2019
- First submitted
- 26 Jan 2015
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Art-therapy in Psychotic Disorders
- ClinicalTrials.gov ID
- NCT02383095
- Acronym / sponsor ID
- 5937
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Art-therapy, Visual organization
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties of recruitment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 27 May 2015 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 9 Mar 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.
The main purpose of the protocol is to test the efficiency of art-therapy versus metacognitive rehabilitation on the visual perception disorders observed in patients with schizophrenia.
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: Art therapy16 Art-therapy sessions |
| Metacognitive therapy | Active comparator | Behavioral: metacognitive therapy16 Metacognitive therapy sessions |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- schizophrenia according to DSM IV
Key exclusion criteria (3 listed)
- addiction problem
- invalidating visual sensory problems
- neurological history
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 |
|---|---|---|
| Art therapy | Behavioural | Art-therapy |
| metacognitive therapy | Behavioural | Metacognitive therapy |
Primary outcome
Change in Response times between baseline and after 16 therapy sessions
Time frame: Baseline and after 16 therapy sessions (up to 6 months)
3 secondary outcomes
Change in Clinical scales (SAPS and SANS) between baseline and after 16 therapy sessions
Time frame: Baseline and after 16 therapy sessions (up to 6 months)
Change in esthetic perception between baseline and after 16 therapy sessions
Time frame: Baseline and after 16 therapy sessions (up to 6 months)
Change in errors in visual organization tasks between baseline and after 16 therapy sessions
Time frame: aseline and after 16 therapy sessions (up to 6 months)
Results and safety
The study was stopped early (reason given: Difficulties of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
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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.
Anne GIERSCH, PhD principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art therapy and metacognitive therapy in people with Schizophrenia, run by University Hospital, Strasbourg, France at 1 site in France.
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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 21 Oct 2019. 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 France. 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 was stopped early (reason given: Difficulties of recruitment). Results are not available in the source record.
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 Response times between baseline and after 16 therapy sessions (time frame: Baseline and after 16 therapy sessions (up to 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2019.