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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00131781
Other study ID # 2000.230
Secondary ID
Status Active, not recruiting
Phase N/A
First received August 18, 2005
Last updated April 26, 2007
Start date March 2001

Study information

Verified date April 2007
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical 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. Patients received one session a week during six months and one session every two weeks during the next six months


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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 70
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- DSM-4 DIBR >=8 (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Diagnostic inventory for borderline-revised)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind


Related Conditions & MeSH terms


Intervention

Behavioral:
Cognitive Therapy

Supportive Therapy


Locations

Country Name City State
France Hopital Pierre Wertheimer Bron

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 CGI severity and improvement
Secondary Hamilton depression
Secondary Beck Depression Inventory
Secondary Hopelessness
Secondary Young: Schema Questionnaire II
Secondary Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Personality Disorders Personality Questionnaire (SCID II PQ)
Secondary Minnesota Multiphasic Personality Inventory (MMPI) (minimult)
Secondary Eysenck: impulsivity scale
Secondary Checklist: impulsive risky behaviors
Secondary Quality of life
Secondary Handicap (Sheehan)
Secondary Time: Pre test, six months, post test and one year post treatment follow-up
Secondary Therapeutic relationship evaluation scale (patients and therapists)
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