NCT02383095

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started May 2015

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

May 27, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

October 21, 2019

Status Verified

October 1, 2019

Enrollment Period

4.4 years

First QC Date

January 26, 2015

Last Update Submit

October 18, 2019

Conditions

Schizophrenia

Keywords

SchizophreniaArt-therapyVisual organization

Outcome Measures

Primary Outcomes (1)

  • Change in Response times between baseline and after 16 therapy sessions

    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

    Baseline and after 16 therapy sessions (up to 6 months)

  • Change in esthetic perception between baseline and after 16 therapy sessions

    Baseline and after 16 therapy sessions (up to 6 months)

  • Change in errors in visual organization tasks between baseline and after 16 therapy sessions

    aseline and after 16 therapy sessions (up to 6 months)

Study Arms (2)

Art-therapy

EXPERIMENTAL

16 Art-therapy sessions

Behavioral: Art therapy

Metacognitive therapy

ACTIVE COMPARATOR

16 Metacognitive therapy sessions

Behavioral: metacognitive therapy

Interventions

Art therapyBEHAVIORAL
Art-therapy
metacognitive therapyBEHAVIORAL
Metacognitive therapy

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • schizophrenia according to DSM IV

You may not qualify if:

  • addiction problem
  • invalidating visual sensory problems
  • neurological history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de psychiatrie, Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Art Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Anne GIERSCH, PhD

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2015

First Posted

March 9, 2015

Study Start

May 27, 2015

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

October 21, 2019

Record last verified: 2019-10

Locations

FR(1)