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Response Shift and Quality of Life in Patients Suffering From Schizophrenia and Their Caregivers

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02868307
Acronym
SCHIFT
Enrollment
200
Registered
2016-08-16
Start date
2012-07-31
Completion date
2017-01-31
Last updated
2016-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Brief summary

Quality of life (QoL) measurements have become an important way to evaluate the treatments and care provided to patients with schizophrenia. Understanding determinants of QoL in schizophrenia is of importance for developing effective interventions that would improve patient functional and subjective well-being. A challenge in the interpretation of QoL measures, especially in longitudinal studies, is that QoL is self-reported by the patient and might be influenced by psychological phenomena such as adaptation to illness. An important mediator of this adaptation process is a response shift (RS), which involves changing internal standards, values and the conceptualization of QoL. RS can be divided into three phases 1) reconceptualization (i.e., a redefinition of QoL), 2) reprioritization (i.e., a change in the importance attributed to component domains constituting QoL) and 3) recalibration (i.e., a change in a patient's internal standards of measurements). Patients may change their frame of reference, rendering scores from different measurement occasions incomparable. An RS is a potential explanation when the QoL of an individual who has experienced a serious health event or chronic condition is similar to the QoL of a healthy individual. With an RS, the concept of QoL changes over time and cannot be compared longitudinally because of changes in internal standards, values, and/or concepts. True change may be over- or underestimated when a RS is present, leading to biased estimates of the magnitude of change.The objective is to examine whether a response shift, a change in the internal standards of a patient, occurs in patients suffering from schizophrenia and in their caregivers. This is a monocentric and propective design study, with inclusion of patients and caregivers on a 12-month period, and a follow up on a 12-month period. 100 patients with schizophrenia and 100 caregivers Test approach (Response shift (RS) (pre-test - then-test), unadjusted effect (post-test - pre-test), and adjusted effect (post-test - then-test scores)) will be completed with other statistical approaches such as confirmatory factorial analysis, multilevel models and CART method.

Interventions

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Caregiver:: * Person identified by the patient as the family member or friend who provided the most support or assistance, * Informed consent obtained * Being a native French speaker Inclusion criteria patients: * Suffering of schizophrenia according DSM IV, * Informed consent obtained * Being a native French speaker

Exclusion criteria

* Patient suffuring of demencia

Design outcomes

Primary

MeasureTime frame
Numbers of response shift occuring in patients suffering from schizophrenia and in their caregivers12 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026