NCT05566015

Brief Summary

Treatment adherence is defined by the World Health Organisation (WHO) as the extent to which the patient's history of therapeutic drug-taking coincides with the prescribed treatment. In patients suffering from psychiatrical diseases, especially in those who are suffering from schizophrenic spectrum disorders, the quality of treatment adherence has to be improved. Indeed, non adherance to anti-psychotic treatment increases the risk of hospitalization, of substance use, violent behaviour and of functionnal and cognitif impairment. Selfcompassion, which involves being touched by and open to one's own suffering and to heal oneself with kindness and without judgement and self-criticism has never beed studied as a possible factor infuencing treatment adherence. This study aims to evaluate if a link between selfcompassion and treatment adherence exists in patients suffering from schizophrenic spectrum disorders.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

September 30, 2022

Last Update Submit

July 18, 2023

Conditions

Keywords

Treatment AdherenceSelfcompassionschizophrenic spectrum disorder

Outcome Measures

Primary Outcomes (1)

  • Average level of self compassion

    The level of self compassion will be assessed with the french version of the Self-compassion scale developped and tested by K.Neff. Average scores for the Self-Compassion Scale are around 3.0 on the 1-5 Likert scale, a score of 1-2.5 indicates low self-compassion, 2.5-3.5 indicates moderate, and 3.5-5.0 is an indication of high self-compassion

    one hour

Interventions

self-administered questionnaires as well as clinical assessment of schizophrenia symptoms and depression.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients diagnosed with schizophrenia spectrum disorder ( ICD 10 and DSM 5 criteria)
  • stabilized (PANNS score under 80)
  • aged 18 or above
  • In case of tutor or curator, agreement of this person is requiered
  • psychiatrist who's following the patient agrees with the study

You may not qualify if:

  • underage
  • non stabilized patient (PANSS score under 80 )
  • patient suffering from toxic psychosis
  • difficulties to understand french or cognitive impairment which are making it to difficult to answer the different self-administered questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

Treatment Adherence and Compliance

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2022

First Posted

October 4, 2022

Study Start

September 26, 2022

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

July 20, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations