Treatment AdherenceCompaSchizoNCT05566015
Relationship Between Self-compassion and Treatment Adherence in Schizophrenic Spectrum Disorders
A study testing questionnaire in people with Treatment Adherence and Selfcompassion, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Adherence, Selfcompassion, Schizophrenic Spectrum Disorder
- What is being tested?
- questionnaire
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2022to 1 Jul 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- questionnaire
- Keywords
- Treatment Adherence, Selfcompassion, schizophrenic spectrum disorder
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
self-administered questionnaires as well as clinical assessment of schizophrenia symptoms and depression.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start26 Sep 2022
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Why it stopped: no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment AdherenceStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Crysalid center Clermont de l'Oise, CMP de Montataire, CMP de Chambly, CMP de Clermont de l'Oise, CMP de st Just en Chaussée, CMP de Senlis, CMP de Crepy en Valois, CMP de Pont St Maxence, CMP de Chantilly, CMP de Creil
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566015
- Sponsor's protocol ID
- PI2019_843_0021
- Acronym
- CompaSchizo
- Status last verified
- Jul 2023
- First submitted
- 30 Sep 2022
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Self-compassion and Treatment Adherence in Schizophrenic Spectrum Disorders
- ClinicalTrials.gov ID
- NCT05566015
- Acronym / sponsor ID
- CompaSchizo / PI2019_843_0021
- Keywords
- Treatment Adherence, Selfcompassion, schizophrenic spectrum disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Crysalid center Clermont de l'Oise, CMP de Montataire, CMP de Chambly, CMP de Clermont de l'Oise, CMP de st Just en Chaussée, CMP de Senlis, CMP de Crepy en Valois, CMP de Pont St Maxence, CMP de Chantilly, CMP de Creil
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 4 Oct 2022 (actual)
- 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| questionnaireself-administered questionnaires as well as clinical assessment of schizophrenia symptoms and depression. | Other | – |
Primary outcome
Average level of self compassion
Time frame: one hour
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire in people with Treatment Adherence and Selfcompassion, run by Centre Hospitalier Universitaire, Amiens 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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 20 Jul 2023. 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 withdrawn before enrolling participants, so there are no results.
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?
Average level of self compassion (time frame: one hour). 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 20 Jul 2023.