Borderline Personality DisorderNCT00603421
Effectiveness of a 24 Hour Phone Line on the Rate of Suicide Attempts in Borderline Patients
A study testing 24 hour phone line and treatment as usual in people with Borderline Personality Disorder, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
This randomized multicentric clinical trial assesses the effectiveness of 24 hour phone line on the rate of suicide attempts and self-injurious behaviors in borderline patients. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- 24 hour phone line and treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2009to Dec 2014
- 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 40 years old
- in or out-patient in one of the recruiting center
- men or women
- with a borderline personality disorder
- written informed consent
Who cannot join
- inferior to 18 or superior to 40 years old
- schizophrenia
- severe somatic disorder
- participation refusal
- participation to another interventional study
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital St Anne
Paris, 75014
Hopital Cochin Centre de recherche Clinique Paris Centre
Paris, 75679
About this study
This randomized multicentric clinical trial assesses the effectiveness of 24 hour phone line on the rate of suicide attempts and self-injurious behaviors in borderline patients.
Read the detailed description
Borderline personality disorder is very frequent among psychiatric populations, and chronic suicidality is a major problem in clinical practice with borderline patients. In a lot of countries, suicide prevention centers are available, but most of these centers are not supervised by professionals of mental health, and none is specifically oriented to the borderline population.
The main goal of this study is to assess the effectiveness of a 24 hour crisis phone line on the rate of suicide attempts in a clinical population of borderline patients (the effectiveness of this phone line access on the rate of self-injurious behaviours will also be studied).
In this multicentric controlled trial, 600 borderline patients (men or women, in or out-patients, between 18 and 40 years-old) are randomized in two arms :
- one with treatment as usual
- one with treatment as usual, PLUS one year of access to a 24 hour crisis phone line (with a team of psychiatrists specialized in borderline personality disorder).
All patients are assessed with standardized instruments (interviewers are blind to the patient's status), at entry (T1) and one year later (T2).
- Conditions
- Borderline Personality Disorder
- Being tested
- 24 hour phone line, treatment as usual
- Keywords
- borderline personality disorder, suicide, suicidality, suicide attempt, suicidal behavior, self-injurious behavior, self-harm behavior, suicide prevention center, telephone intervention
- Medical subject headings
- Borderline Personality Disorder, Suicide, Suicidal Ideation, Suicide, Attempted, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24 hour phone lineOther
24 hour phone line is available as soon as the patient himself feels necessary. This phone line is supported by professionals of mental health, all specialised in borderline personality disorder
treatment as usualOther
Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patient benefits from treatment as usual plus access to a crisis 24 hour phone line. Receives: Other: 24 hour phone line |
| 2 | Active comparator | Patient benefits from treatment as usual Receives: Other: treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of suicide attempts
Measured: Annual
Secondary outcomes (1)
rate of self injurious behaviors
Measured: annual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2008 (estimated)
- Study startFeb 2009
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra Pham-Scottez, MD, Principal investigator, Centre Hospitalier Sainte Anne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603421
- Sponsor's protocol ID
- AOM 05062
- Status last verified
- Feb 2016
- First submitted
- 16 Jan 2008
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
PubMed 33884617Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
PubMed 32368793
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a 24 Hour Phone Line on the Rate of Suicide Attempts in Borderline Patients
- ClinicalTrials.gov ID
- NCT00603421
- Acronym / sponsor ID
- AOM 05062
- Conditions
- Borderline Personality Disorder
- Keywords
- borderline personality disorder, suicide, suicidality, suicide attempt, suicidal behavior, self-injurious behavior, self-harm behavior, suicide prevention center
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Jan 2008 (estimated)
- 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.
This randomized multicentric clinical trial assesses the effectiveness of 24 hour phone line on the rate of suicide attempts and self-injurious behaviors in borderline patients.
Detailed description
Borderline personality disorder is very frequent among psychiatric populations, and chronic suicidality is a major problem in clinical practice with borderline patients. In a lot of countries, suicide prevention centers are available, but most of these centers are not supervised by professionals of mental health, and none is specifically oriented to the borderline population.
The main goal of this study is to assess the effectiveness of a 24 hour crisis phone line on the rate of suicide attempts in a clinical population of borderline patients (the effectiveness of this phone line access on the rate of self-injurious behaviours will also be studied).
In this multicentric controlled trial, 600 borderline patients (men or women, in or out-patients, between 18 and 40 years-old) are randomized in two arms :
- one with treatment as usual
- one with treatment as usual, PLUS one year of access to a 24 hour crisis phone line (with a team of psychiatrists specialized in borderline personality disorder).
All patients are assessed with standardized instruments (interviewers are blind to the patient's status), at entry (T1) and one year later (T2).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: 24 hour phone linePatient benefits from treatment as usual plus access to a crisis 24 hour phone line. |
| 2 | Active comparator | Other: treatment as usualPatient benefits from treatment as usual |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18 to 40 years old
- in or out-patient in one of the recruiting center
- men or women
- with a borderline personality disorder
- written informed consent
Key exclusion criteria (5 listed)
- inferior to 18 or superior to 40 years old
- schizophrenia
- severe somatic disorder
- participation refusal
- participation to another interventional study
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 |
|---|---|---|
| 24 hour phone line24 hour phone line is available as soon as the patient himself feels necessary. This phone line is supported by professionals of mental health, all specialised in borderline personality disorder | Other | 1 |
| treatment as usualTreatment as usual | Other | 2 |
Primary outcome
Rate of suicide attempts
Time frame: Annual
1 secondary outcome
rate of self injurious behaviors
Time frame: annual
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 Feb 2016.
- Derived from this study: PubMed 33884617Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
- Derived from this study: PubMed 32368793Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
- 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.
Alexandra Pham-Scottez, MD principal investigator
Centre Hospitalier Sainte Anne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 24 hour phone line and treatment as usual in people with Borderline Personality Disorder, run by Assistance Publique - Hôpitaux de Paris at 2 sites 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 5 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 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 suicide attempts (time frame: Annual). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00603421, which also lists 2 linked publications.
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 Feb 2016.