Borderline Personality DisorderNCT00131781
Cognitive Therapy Versus Supportive Therapy in Borderline Personality Disorder
A study testing Cognitive Therapy and Supportive Therapy in people with Borderline Personality Disorder, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
This is a randomised trial comparing cognitive therapy and supportive therapy administered along one year in borderline personality disorder. The follow-up is one year after treatments end. The therapists were the same in the two groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Cognitive Therapy and Supportive Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2001to not given
- 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 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- DSM-4 DIBR >=8 (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Diagnostic inventory for borderline-revised)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomised trial comparing cognitive therapy and supportive therapy administered along one year in borderline personality disorder. The follow-up is one year after treatments end.
The therapists were the same in the two groups. Patients received one session a week during six months and one session every two weeks during the next six months
Read the detailed description
- Cognitive Therapy
- Structured session
- Conceptualization of the case with the patient
- Cognitive methods
- Guided discovery of the schemas
- Work on life-scenarios
- From scenarios to schemas
- Empathic confrontation to the schemas
- Building new schemas (Core belief work-sheet)
- Affective methods: role playing
- Interpersonal methods: counter transference issues
- Behavioral experiment
- Problem solving
- Consolidation methods
- Patients and therapists had manuals
- Supportive Therapy
- Therapist: active listening (face to face)
- Empathy
- Unconditional positive regard
- Reformulation and clarification
- Reflection of the patient's feelings
- Reassurance
- Therapist emphasizes the importance to ventilate problems
- Therapist answers some factual questions
- Therapist politely ignore or refuse requests for advice and directive attitudes
- Therapist demonstrates warmth and genuineness
- Patients and therapists had manuals
- Conditions
- Borderline Personality Disorder
- Being tested
- Cognitive Therapy, Supportive Therapy
- Keywords
- Borderline personality disorder, Controlled trials, Cognitive Therapy, Supportive Therapy, suicide, impulsivity
- Medical subject headings
- Borderline Personality Disorder, Suicide, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TherapyBehavioural
Supportive TherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression (CGI): Improvement (1-7): score 3 ( a little better) associated with a hopelessness scale score < 8 (this means that the suicide risk is low)
Secondary outcomes (13)
CGI severity and improvement
Hamilton depression
Beck Depression Inventory
Hopelessness
Young: Schema Questionnaire II
Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Personality Disorders Personality Questionnaire (SCID II PQ)
Minnesota Multiphasic Personality Inventory (MMPI) (minimult)
Eysenck: impulsivity scale
Checklist: impulsive risky behaviors
Quality of life
Handicap (Sheehan)
Time: Pre test, six months, post test and one year post treatment follow-up
Therapeutic relationship evaluation scale (patients and therapists)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2005 (estimated)
- Study startMar 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Hospices Civils de LyonThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- Jean COTTRAUX, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131781
- Sponsor's protocol ID
- 2000.230
- Status last verified
- Apr 2007
- First submitted
- 18 Aug 2005
- Last updated
- 27 Apr 2007
- Results posted
- No
Publications
Storebo 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 27 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Therapy Versus Supportive Therapy in Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT00131781
- Acronym / sponsor ID
- 2000.230
- Conditions
- Borderline Personality Disorder
- Keywords
- Borderline personality disorder, Controlled trials, Cognitive Therapy, Supportive Therapy, suicide, impulsivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2001
- First posted
- 19 Aug 2005 (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 is a randomised trial comparing cognitive therapy and supportive therapy administered along one year in borderline personality disorder. The follow-up is one year after treatments end.
The therapists were the same in the two groups. Patients received one session a week during six months and one session every two weeks during the next six months
Detailed description
- Cognitive Therapy
- Structured session
- Conceptualization of the case with the patient
- Cognitive methods
- Guided discovery of the schemas
- Work on life-scenarios
- From scenarios to schemas
- Empathic confrontation to the schemas
- Building new schemas (Core belief work-sheet)
- Affective methods: role playing
- Interpersonal methods: counter transference issues
- Behavioral experiment
- Problem solving
- Consolidation methods
- Patients and therapists had manuals
- Supportive Therapy
- Therapist: active listening (face to face)
- Empathy
- Unconditional positive regard
- Reformulation and clarification
- Reflection of the patient's feelings
- Reassurance
- Therapist emphasizes the importance to ventilate problems
- Therapist answers some factual questions
- Therapist politely ignore or refuse requests for advice and directive attitudes
- Therapist demonstrates warmth and genuineness
- Patients and therapists had manuals
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- DSM-4 DIBR >=8 (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Diagnostic inventory for borderline-revised)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Cognitive Therapy | Behavioural | – |
| Supportive Therapy | Behavioural | – |
Primary outcome
Clinical Global Impression (CGI): Improvement (1-7): score 3 ( a little better) associated with a hopelessness scale score < 8 (this means that the suicide risk is low)
13 secondary outcomes
CGI severity and improvement
Hamilton depression
Beck Depression Inventory
Hopelessness
Young: Schema Questionnaire II
Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Personality Disorders Personality Questionnaire (SCID II PQ)
Minnesota Multiphasic Personality Inventory (MMPI) (minimult)
Eysenck: impulsivity scale
Checklist: impulsive risky behaviors
Quality of life
Handicap (Sheehan)
Time: Pre test, six months, post test and one year post treatment follow-up
Therapeutic relationship evaluation scale (patients and therapists)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2007.
- 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.
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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.
Jean COTTRAUX, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Therapy and Supportive Therapy in people with Borderline Personality Disorder, run by Hospices Civils de Lyon 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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 27 Apr 2007. 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?
Results are not available in the source record.
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?
Clinical Global Impression (CGI): Improvement (1-7): score 3 ( a little better) associated with a hopelessness scale score < 8 (this means that the suicide risk is low). 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 NCT00131781, which also lists 1 linked publication.
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 27 Apr 2007.