Borderline Personality DisorderNCT01531634
Promoting Recovery Processes in Women With Borderline Personality Disorder Using a Dynamic Cognitive Intervention
A study testing Dynamic Cognitive Intervention Group in people with Borderline Personality Disorder, run by Hillel Yaffe Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Dynamic Cognitive Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Start not givento 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women
- Age 18 - 45
- Borderline Personality Disorder, by DSM-V
Who cannot join
- Current Acute Depressive Episode
- Current Psychotic Episode
- Less Than 12 school years
- Non Compliance with therapy
- Dual diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promoting Recovery Processes in Women Diagnosed With Borderline Personality Disorder Using a Dynamic Cognitive Intervention
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.
Read more
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.
- Conditions
- Borderline Personality Disorder
- Being tested
- Dynamic Cognitive Intervention Group
- Keywords
- Borderline Personality Disorder, Women, Dynamic Cognitive Intervention, Recovery, Hope Scale
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Cognitive Intervention GroupBehavioural
Also called DCI
Twelve meetings of a Dynamic Cognitive Intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic Cognitive Intervention Group | Active comparator | Twelve Meetings of Dynamic Cognitive Intervention. Receives: Behavioral: Dynamic Cognitive Intervention Group |
| No Additional Intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline in Recovery Assessment Scale at 12th meeting (6 up to 12 weeks)
Secondary outcomes (2)
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.
Measured: Change from baseline in Hope Scale at 12th meeting (6 up to 12 weeks)
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.
Measured: Change from baseline in Brief Symptom Inventory at 12th meeting (6 up to 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Investigators
- Orly Tsabar, B.O.T., Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531634
- Sponsor's protocol ID
- 0010-12-HYMC
- Status last verified
- Feb 2012
- First submitted
- 3 Feb 2012
- Last updated
- 13 Feb 2012
- Results posted
- No
- Data monitoring committee
- 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 13 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Recovery Processes in Women Diagnosed With Borderline Personality Disorder Using a Dynamic Cognitive Intervention
- ClinicalTrials.gov ID
- NCT01531634
- Acronym / sponsor ID
- 0010-12-HYMC
- Conditions
- Borderline Personality Disorder
- Keywords
- Borderline Personality Disorder, Women, Dynamic Cognitive Intervention, Recovery, Hope Scale
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- First posted
- 13 Feb 2012 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic Cognitive Intervention Group | Active comparator | Behavioral: Dynamic Cognitive Intervention GroupTwelve Meetings of Dynamic Cognitive Intervention. |
| No Additional Intervention | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women
- Age 18 - 45
- Borderline Personality Disorder, by DSM-V
Key exclusion criteria (5 listed)
- Current Acute Depressive Episode
- Current Psychotic Episode
- Less Than 12 school years
- Non Compliance with therapy
- Dual diagnosis
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 |
|---|---|---|
| Dynamic Cognitive Intervention GroupAlso: DCITwelve meetings of a Dynamic Cognitive Intervention group. | Behavioural | Dynamic Cognitive Intervention Group |
Primary outcome
Change in Recovery Assessment Scale
Time frame: Change from baseline in Recovery Assessment Scale at 12th meeting (6 up to 12 weeks)
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.
2 secondary outcomes
Change in Hope Scale
Time frame: Change from baseline in Hope Scale at 12th meeting (6 up to 12 weeks)
Change in Brief Symptom Inventory
Time frame: Change from baseline in Brief Symptom Inventory at 12th meeting (6 up to 12 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2012.
- 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.
Orly Tsabar, B.O.T. principal investigator
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Cognitive Intervention Group in people with Borderline Personality Disorder, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 3 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: status not confirmed, as of the sponsor's last update on 13 Feb 2012. 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 Israel. 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?
Contact Orly Tsabar, B.O.T. (972-54-6852344, orly.tsabar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Recovery Assessment Scale (time frame: Change from baseline in Recovery Assessment Scale at 12th meeting (6 up to 12 weeks)). 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 NCT01531634, 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 13 Feb 2012.