Effectiveness of the Iconic Therapy for Borderline Personality Disorder Symptoms

May 13, 2018 updated by: Silvia Elisa Hurtado Santiago

Effectiveness of the Iconic Therapy in Youth With Suicidal Ideation/Self-injuring Behavior and Borderline Personality Traits: Study Protocol for a Randomized Controlled Trial

Borderline personality disorder (BPD) is the most prevalent personality disorder in young community population whose most severe complication is suicide. Pharmacotherapy should not be used as the primary treatment for BPD as the benefits are unclear. Psychotherapy is the main treatment for people with BPD and the current recommendation is adapting available comprehensive treatments to develop easier and briefer therapies that are also effective. Iconic Therapy is an innovative option whose good clinical results should be validated on a clinical trial.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Borderline Personality Disorder (BPD) in the early adulthood is an increasing diagnosis among general population. First symptoms detection and early intervention might help prevent its aggravation and further BPD diagnosis. Iconic Therapy is an innovative manual-driven psychotherapy to specifically and intensively treat BPD symptoms. Preliminary clinical results are good. The aim of the present study is to assess the effectiveness of the Iconic Therapy in comparison to a support structured therapy in an ecological setting (Spanish public specialized mental health care). The study is planned as a randomized controlled prospective trial that will randomize 60 young people (15 to 25 years old) with suicidal ideation/self-injuring behaviour and borderline personality traits. Participants will be randomly assigned to one of the two groups: Iconic Therapy or support structured therapy on a 1:1 basis. Both the Iconic Therapy and the support therapy programs consist of 10-12 weekly sessions delivered by two trained psychologists for about 8-12 outpatients on group format. The primary outcome measure is the change of symptoms severity assessed by the Borderline Personality Disorder List (BSL-23). Secondary outcomes include suicidal ideation and behavior, non-suicidal self-injures maladjustment to the daily life and economic evaluation for health care. Assessments will be performed at baseline after the intervention 6 and 12 months of follow-up. It is hypothesized that those attending the Iconic Therapy group will show a permanently reduction of the severity of symptoms as compared with those attending the structured support group. Data will be analyzed using generalized estimating equations (GEE) models.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Malaga, Spain, 29190
        • Silvia E. Hurtado-Santiago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 15-25 years old
  • Suicidal ideation and/or self-injuring behavior
  • BPD behavioural trends defined as the cut point for alarming BPD traits (>38 score) on Exploratory Questionnaire of Personality-III-BPD (CEPER-III-BPD)
  • Sufficiently proficient in Spanish to follow the treatment

Exclusion Criteria:

  • Antisocial personality disorder as measured in the Clinical Interview for Diagnostic and Statistical Manual (DSM-IV Axis II) (SCID-II)
  • Substance or alcohol abuse
  • High suicidal risk
  • Negative expectations to be enrolled in the study as measured < 35 by the Expectation of Treatment Scale (ETS)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Iconic Therapy
The Iconic Therapy program consists of two parts: a) an intensive program of 10-12-week basic skills group 60-minute duration with a range of 6 to 8 face-to-face inserted sessions and b) an additional one-year program of 4 to 6 gradually less frequent face-to-face sessions. The groups are typically lead by two trainers -therapist and co-therapist- for about 8-12 outpatients. Added to these established sessions, a variable number of face-to-face individual sessions with the principal investigator will also take place. They will depend on participant´s requirements. They will consist on coaching their demands and providing human support throughout the study.
Behavioral: Emotional regulation
Educate people with difficulty in regulating their emotions and help them acquire skills to do so
Active Comparator: Support therapy
Support therapy consist of 10-12 weekly group sessions of 60-minute duration. Patients and trainers will learn and debate about different behavioral aspects of the borderline personality disorder: emotional instability and impulses control, Jacobson relaxation technique, self-image and communicational styles, mindfulness, self-esteem or social skills to name a few. The groups are typically lead by two trainers -therapist and co-therapist- for about 8-12 outpatients.Added to these established group sessions, a variable number of face-to-face individual sessions with the principal investigator will also take place. They will depend on participant´s requirements. They will consist on coaching their demands and providing human support throughout the study.
Behavioral: Emotional regulation
Educate people with difficulty in regulating their emotions and help them acquire skills to do so

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change on the severity of borderline personality disorder measured by Borderline Personality Symptom List (BSL-23).
Time Frame: Baseline and up to 12 months after inclusion.
This questionnaire (BSL-23) is a dimensional instrument: the most widely used to assess borderline personality disorder symptomatology improvement in clinical trials. The Spanish validated version of the questionnaire will be used.
Baseline and up to 12 months after inclusion.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sociodemographic variables
Time Frame: Baseline
The following socio-demographic data will be collected: gender, age, marital status, parents´nationality, coexistence (no studies, primary studies, Secondary studies, University, Professional formation), occupation (student, working, both studying and working, pensioner) and family member or allied friend´s phone number for further contacts.
Baseline
Change on the suicidal ideation and behavior measured by the Columbia Suicide History Form (SSRS).
Time Frame: Baseline and up to 12 months after inclusion.
this instrument measures ideation (wish, thinking, intention and plan), ideation severity (frequency, duration, control capacity, disuasory elements and reasons) and suicidal behavior (attempts and acts). It is considered an adequate tool for treatment planning and research.
Baseline and up to 12 months after inclusion.
Change on non-suicidal self-injure diagnosis
Time Frame: Baseline and up to 12 months after inclusion.
It does not exist a specific validated scale to assess non suicidal self injures so the investigators collected and asked about all the 6 Diagnostic and Statistical Manual (DSM-V) criteria. The investigators aim to separately describe the incidence of suicide attempts/acts vs non suicidal self injures in this study.
Baseline and up to 12 months after inclusion.
Change on the economic evaluation measured by the Client Service Receipt Inventory (CSRI) - adapted Spanish version (CSRI-Spanish version)
Time Frame: Baseline and up to 12 months after inclusion.
Questionnaire to assess use of healthcare/social care services and other economic impacts. This instrument has two subscales to assess either direct costs (emergency services/hospital admissions use, specialised medical consultations, prescribed diagnosis trials and consumed medication) or indirect costs (absenteeism and quantity/quality of job performance on a 100-point scales).
Baseline and up to 12 months after inclusion.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change on the maladjustment to the daily life measured by the Maladjustment Scale (EI).
Time Frame: Baseline and up to 12 months after inclusion.
It is a brief instrument of 6 self-report items assessing maladjustment to the daily life on psychiatric population. A six point Likert scale ranging from 0 (not at all) to 5 (very strong) is used. It is sensitive to therapeutic changes.
Baseline and up to 12 months after inclusion.
Satisfaction with the treatment assessed by the Opinion of treatment scale (OTS).
Time Frame: Through therapy completion, an average of 12 weeks.
It is a quick and easy to administer 6-item scale for assessing satisfaction and rationale credibility : how believable, convincing and logical the treatment was from 0 (not at all) to 10 (very strong).
Through therapy completion, an average of 12 weeks.
Change on the perceived subjective global improvement measured on a 7-point ad hoc Likert scale
Time Frame: Through therapy completion (an average of 12 weeks) and up to 12 months after inclusion
Participants will be asked about their subjective impression : much/quite/little bit better, the same or much/quite/little bit worse compared to when they entered the study.
Through therapy completion (an average of 12 weeks) and up to 12 months after inclusion
Change on family and friends´ perceived global improvement
Time Frame: Through therapy completion (an average of 12 weeks) and up to 12 months after inclusion
Family and friend´s perceived global improvement will be asked on a 7-point ad hoc Likert scale: much/quite/little bit better, the same or much/quite/little bit worse compared to when they entered the study.
Through therapy completion (an average of 12 weeks) and up to 12 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Silvia Elisa Hurtado Santiago

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Rosa Bersabé, Psychologist, Malaga University
  • Study Director: Fermín Mayoral, Psychiatrist, Hospital Regional de Malaga

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • shs-ico-2015-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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