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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01531634
Other study ID # 0010-12-HYMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 3, 2012
Last updated February 8, 2012

Study information

Verified date February 2012
Source Hillel Yaffe Medical Center
Contact Orly Tsabar, B.O.T.
Phone 972-54-6852344
Email orly.tsabar@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

The field of psychiatric rehabilitation focuses on creating a personal narrative and developing coping strategies and environmental supports. The concept of recovery is person-centered and emphasizes the person's ability to change and to live meaningful life. The strengths approach has a central role in the recovery concept, emphasizing the person's abilities and potential. A preserved cognitive ability can be a significant strength in the recovery process.

Research had shown growing support for the use of cognitive-behavioral approaches as the most effective therapy for people with borderline personality disorder, using structured interventions. A central focus in cognitive therapy is the change of maladaptive schemes. The dynamic-cognitive intervention (DCI) is based on the understanding of structural cognitive modifiability and suggests the use of mediated learning in order to enhance sense of competence and develop better psychological coping skills.

The present study will focus on women diagnosed with borderline personality disorder, with normative cognitive ability seen as a strength as opposed to their emotional ability. This study will examine the effects of a Dynamic Cognitive Intervention on recovery measures and on symptoms severity.

The study will include 30 women aged 18-45 years. Participants will be randomly assigned to an intervention group and a control group. All participants will be assessed before and after intervention using Recovery Assessment Scale, Hope Scale and The Brief Symptom Inventory.

The intervention designed for this study is based on the principles of the Dynamic Cognitive Intervention. The intervention tools that will be used include: a. Instrumental Enrichment tools. b. life events analysis. c. Stories, lyrics and movie clips. d. Worksheets. The intervention encompasses 12 sessions of 1.5 hours, with a routine structure.

The results are expected to contribute to the understanding of the impact of a dynamic cognitive intervention in women diagnosed with borderline personality disorder.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Women

- Age 18 - 45

- Borderline Personality Disorder, by DSM-V

Exclusion Criteria:

- Current Acute Depressive Episode

- Current Psychotic Episode

- Less Than 12 school years

- Non Compliance with therapy

- Dual diagnosis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Dynamic Cognitive Intervention Group
Twelve meetings of a Dynamic Cognitive Intervention group.

Locations

Country Name City State
Israel Day Center for Mentally Ill Netanya

Sponsors (1)

Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Recovery Assessment Scale A baseline Recovery Assessment Scale will be used on the first intervention group meeting. Recovery Assessment Scale will be used again on the last (i.e. 12th) intervention group meeting. Change from baseline in Recovery Assessment Scale at 12th meeting (6 up to 12 weeks) No
Secondary Change in Hope Scale A baseline Hope Scale will be used on the first intervention group meeting. Hope Scale will be used again on the last (i.e. 12th) intervention group meeting. Change from baseline in Hope Scale at 12th meeting (6 up to 12 weeks) No
Secondary Change in Brief Symptom Inventory A baseline Brief Symptom Inventory will be used on the first intervention group meeting. Brief Symptom Inventory will be used again on the last (i.e. 12th) intervention group meeting. Change from baseline in Brief Symptom Inventory at 12th meeting (6 up to 12 weeks) No
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