- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02033044
Cognitive Rehabilitation Versus Psychoeducation in Psychosocial Functioning of Borderline Personality Disorder
Randomized Controlled Trial Comparing the Effects on Psychosocial Functioning of Cognitive Rehabilitation Versus Psychoeducation in Borderline Personality Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
To ensure the reliability among centers regarding the evaluation and the treatment fidelity, two meetings were organized before the start of the study to train therapists in the evaluations and interventions.
Clinical and neuropsychological evaluations before interventions were administered in different days since they lasted in general more than one hour each one and the effect of fatigue or boredom might affect the results. Clinical interviews were performed by experienced psychiatrists and psychologists during 3 months to ensure the follow-up of all participants prospectively. The following sociodemographic and clinical variables were collected: age at recruitment, gender, education level, occupational status, and pharmacological treatment. All participants were then randomized to receive CR or PE in a 1:1 ratio stratified by center, age, and education level. Randomization was accomplished with the use of computer-generated sequence.
During the study, subjects did not receive any other individual or group psychotherapy. All patients continued pharmacological treatment if it had been initiated prior to inclusion. Type and doses of medication could not be modified during the study period. Both interventions were applied in a group format and were conducted by two psychologists with experience in managing patients with BPD. Subjects were instructed not to disclose any information about the intervention to maintain blind conditions. Participants were evaluated at baseline, after completion of the intervention, and six months after the end of the interventions.
The study was conducted in accordance with the ethical principles of the Declaration of Helsinki and the approval of the Ethical Committee for this study was obtained. All subjects received extensive information about the study and provided written informed consent before they were enrolled in the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Madrid, Spain, 28040
- Hospital Clínico San Carlos
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Outpatients aged 18 to 45 years;
- Diagnoses of BPD according to Diagnostic and Statistical Manual for Mental Disorders (4th version Revised) (DSM-IV-TR) criteria and evaluated by two semi-structured diagnostic interviews
- Structured Clinical Interview for DSM-IV Axis II Disorders (SCID-II) and the Revised Diagnostic Interview for Borderlines (DIB-R)
- Clinical severity measured with Clinical Global Impression for BPD (CGI-BPD) higher than 4;
- Functional impairment measured with a Global Assessment Functioning (GAF) lower than 65.
Exclusion Criteria:
- No severe physical conditions, such as organic brain syndrome or neurological disease that could affect neuropsychological performance;
- Intelligence Quotient (IQ) < 85;
- Major Depression Disorder (MDD) or substance misuse within the last 6 months;
- Schizophrenia, severe psychotic disorder or bipolar disorder;
- Previous participation in any psychoeducation or cognitive rehabilitation intervention.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: cognitive remediation
Cognitive remediation programme in order to improve several cognitive domains.
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Cognitive Rehabilitation (CR).
Consisted on group sessions (5 individuals per group) of 120-minutes, twice a week during a total period of 16 weeks (32 sessions).
The exercises addressed neurocognitive issues related to sustained attention, processing speed, memory and executive functioning.
The whole program aimed at getting new strategies to improve functional adaptation, thus tasks were carried out in the clinical setting and at home.
Some homework tasks were based on their daily life difficulties and problems.
The main objective of this program was the generalization of rehabilitated cognitive functions to daily life activities.
Most of the techniques were based on a previous program for bipolar disorder.
Other Names:
|
ACTIVE_COMPARATOR: Psychoeducation
Psychoeducation group in order to improve psychosocial functioning of patients.
|
Psychoeducation (PE).
The psychoeducation intervention consisted of 16 weekly group sessions of 5 individuals of 120 minutes each (16 sessions).
This therapy aimed at improving illness' consciousness , interpersonal abilities, family balance, therapeutical adherence, emotional management in frustrating situations, problems resolutions, and lifestyle regularity.
On this intervention, no homework tasks were required.
This intervention was based on the Systems Training for Emotional Predictability and Problem Solving (STEPPS) program therapy.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functioning Assessment Scale Test (FAST)
Time Frame: up to three years
|
This test is a 24-item scale that measures the level of psychosocial functioning of patients in daily life situations.
It assesses six functional domains: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships, and leisure time.
Higher scores indicate higher functional impairment.
This instrument has shown good psychometric properties and sensitivity to change.
|
up to three years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jose L Carrasco, MD, Hospital Clínico San Carlos
- Study Chair: Juan C Pascual, MD, Hospital San Creu i San Pau
- Study Chair: Angela Ibañez, MD, Hospital Universitario Ramón y Cajal
Publications and helpful links
General Publications
- Torrent C, Bonnin Cdel M, Martinez-Aran A, Valle J, Amann BL, Gonzalez-Pinto A, Crespo JM, Ibanez A, Garcia-Portilla MP, Tabares-Seisdedos R, Arango C, Colom F, Sole B, Pacchiarotti I, Rosa AR, Ayuso-Mateos JL, Anaya C, Fernandez P, Landin-Romero R, Alonso-Lana S, Ortiz-Gil J, Segura B, Barbeito S, Vega P, Fernandez M, Ugarte A, Subira M, Cerrillo E, Custal N, Menchon JM, Saiz-Ruiz J, Rodao JM, Isella S, Alegria A, Al-Halabi S, Bobes J, Galvan G, Saiz PA, Balanza-Martinez V, Selva G, Fuentes-Dura I, Correa P, Mayoral M, Chiclana G, Merchan-Naranjo J, Rapado-Castro M, Salamero M, Vieta E. Efficacy of functional remediation in bipolar disorder: a multicenter randomized controlled study. Am J Psychiatry. 2013 Aug;170(8):852-9. doi: 10.1176/appi.ajp.2012.12070971.
- 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.
- Pascual JC, Palomares N, Ibanez A, Portella MJ, Arza R, Reyes R, Feliu-Soler A, Diaz-Marsa M, Saiz-Ruiz J, Soler J, Carrasco JL. Efficacy of cognitive rehabilitation on psychosocial functioning in Borderline Personality Disorder: a randomized controlled trial. BMC Psychiatry. 2015 Oct 21;15:255. doi: 10.1186/s12888-015-0640-5.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CogRehab
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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