Borderline Personality DisorderNCT04746404
Application of a Positive Psychology Program for the Development of Emotional Skills in Prison
An observational study of Borderline Personality Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Studies show that emotional competence plays a significant role in psychological and physical health, and that programs aimed at their development are effective. Can a positive psychology program aimed at the development of emotional competence be implemented as part of care in lieu of deprivation of liberty? The… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Emotional Skills Development Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 1 Jun 2021
- Phase
- Observational
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Major patients followed up at the Health Unit of the Villeneuve-lès-Maguelone Remand Prison
Who may be able to join
- Meet the criteria for borderline personality disorder (DSM-V),
- Interest in the issue of emotional skills development,
- Comprehension and use of the French language adapted to the study,
- Disposition to group practice,
- Attentive disposition allowing to participate in a therapeutic activity for 3 hours.
- Psychological/psychiatrical follow-up at the Health Unit of the Villeneuve-lès-Maguelone prison
Who cannot join
- Minor patients
- Releasable before July 2021,
- Decompensated psychiatric disorders,
- Patient in withdrawal syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of a Positive Psychology Program for the Development of Emotional Skills in Prison : Feasibility Study
Studies show that emotional competence plays a significant role in psychological and physical health, and that programs aimed at their development are effective. Can a positive psychology program aimed at the development of emotional competence be implemented as part of care in lieu of deprivation of liberty? The investigators hypothesize the interest and possibility of implementing an emotional skills development program in the specific context of custodial care.
The main expected outcome of this study is the identification of necessary adaptations of the emotional skills development program of Kotsou, I. et al (2011) for its implementation in remand homes.
Read the detailed description
The expected secondary outcome is the identification of the interest of emotional skills development program (in prison) regarding :
- Therapeutic support for patients meeting the criteria for borderline personality disorder
- Participant satisfaction
- The development of emotional skills
- Conditions
- Borderline Personality Disorder
- Being tested
- Emotional Skills Development Program
- Keywords
- Borderline
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Skills Development ProgramBehavioural
Emotional Skills Development Program (positive psychology)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Control group : Major borderline patients followed up at the Health Unit of the Villeneuve-lès-Maguelone Remand Prison | |
| Test group | Test group : Major borderline patients followed up at the Health Unit of the Villeneuve-lès-Maguelone Remand Prison Receives: Behavioral: Emotional Skills Development Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of vompliance with the number of sessions
Achievement of the program's implementation and participation objectives : compliance with the number of sessions
Measured: 1 day
Rate of respect of the frequency of sessions
Achievement of the program's implementation and participation objectives : respect of the frequency of sessions: weekly
Measured: 1 day
rate of respect of the duration of each session
Achievement of the program's implementation and participation objectives : respect of the duration of each session
Measured: 1 day
rate of respect of the minimum number of participants
Achievement of the program's implementation and participation objectives : respect of the minimum number of participants
Measured: 1 day
Secondary outcomes (2)
Respect of the duration of the theoretical/practical reminders
Achievement of the program's implementation and participation objectives : Respect of the duration of the theoretical/practical reminders
Measured: 1 day
respect of the frequency of theoretical/practical remote reminders
Achievement of the program's implementation and participation objectives : respect of the frequency of theoretical/practical remote reminders
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Jan 2021
- Primary completion30 May 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magali RUBIO, Psychologist, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746404
- Sponsor's protocol ID
- RECHMPL21_0017
- Status last verified
- Oct 2021
- First submitted
- 29 Jan 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of a Positive Psychology Program for the Development of Emotional Skills in Prison : Feasibility Study
- ClinicalTrials.gov ID
- NCT04746404
- Acronym / sponsor ID
- RECHMPL21_0017
- Conditions
- Borderline Personality Disorder
- Keywords
- Borderline
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 9 Feb 2021 (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.
Studies show that emotional competence plays a significant role in psychological and physical health, and that programs aimed at their development are effective. Can a positive psychology program aimed at the development of emotional competence be implemented as part of care in lieu of deprivation of liberty? The investigators hypothesize the interest and possibility of implementing an emotional skills development program in the specific context of custodial care.
The main expected outcome of this study is the identification of necessary adaptations of the emotional skills development program of Kotsou, I. et al (2011) for its implementation in remand homes.
Detailed description
The expected secondary outcome is the identification of the interest of emotional skills development program (in prison) regarding :
- Therapeutic support for patients meeting the criteria for borderline personality disorder
- Participant satisfaction
- The development of emotional skills
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Control group : Major borderline patients followed up at the Health Unit of the Villeneuve-lès-Maguelone Remand Prison |
| Test group | – | Behavioral: Emotional Skills Development ProgramTest group : Major borderline patients followed up at the Health Unit of the Villeneuve-lès-Maguelone Remand Prison |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major patients followed up at the Health Unit of the Villeneuve-lès-Maguelone Remand Prison
Key inclusion criteria (6 listed)
- Meet the criteria for borderline personality disorder (DSM-V),
- Interest in the issue of emotional skills development,
- Comprehension and use of the French language adapted to the study,
- Disposition to group practice,
- Attentive disposition allowing to participate in a therapeutic activity for 3 hours.
Key exclusion criteria (4 listed)
- Minor patients
- Releasable before July 2021,
- Decompensated psychiatric disorders,
- Patient in withdrawal syndrome.
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 |
|---|---|---|
| Emotional Skills Development ProgramEmotional Skills Development Program (positive psychology) | Behavioural | Test group |
Primary outcome
rate of vompliance with the number of sessions
Time frame: 1 day
Achievement of the program's implementation and participation objectives : compliance with the number of sessions
Rate of respect of the frequency of sessions
Time frame: 1 day
Achievement of the program's implementation and participation objectives : respect of the frequency of sessions: weekly
rate of respect of the duration of each session
Time frame: 1 day
Achievement of the program's implementation and participation objectives : respect of the duration of each session
rate of respect of the minimum number of participants
Time frame: 1 day
Achievement of the program's implementation and participation objectives : respect of the minimum number of participants
2 secondary outcomes
Respect of the duration of the theoretical/practical reminders
Time frame: 1 day
respect of the frequency of theoretical/practical remote reminders
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
Magali RUBIO, Psychologist principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Borderline Personality Disorder, run by University Hospital, Montpellier 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 6 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: finished, as of the sponsor's last update on 25 Oct 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
rate of vompliance with the number of sessions (time frame: 1 day). The study lists 4 primary outcomes in all. 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 25 Oct 2021.