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Effectiveness of the Iconic Therapy for Borderline Personality Disorder Symptoms

Primary Purpose

Personality Disorder, Borderline

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Emotional regulation
Sponsored by
Silvia Elisa Hurtado Santiago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Personality Disorder, Borderline focused on measuring Terapia Iconica, BPD, adolescence, suicide

Eligibility Criteria

15 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Silvia E. Hurtado-Santiago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Iconic Therapy

Support therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change on the severity of borderline personality disorder measured by Borderline Personality Symptom List (BSL-23).
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.

Secondary Outcome Measures

Sociodemographic variables
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.
Change on the suicidal ideation and behavior measured by the Columbia Suicide History Form (SSRS).
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.
Change on non-suicidal self-injure diagnosis
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.
Change on the economic evaluation measured by the Client Service Receipt Inventory (CSRI) - adapted Spanish version (CSRI-Spanish version)
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).

Full Information

First Posted
December 28, 2016
Last Updated
May 13, 2018
Sponsor
Silvia Elisa Hurtado Santiago
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1. Study Identification

Unique Protocol Identification Number
NCT03011190
Brief Title
Effectiveness of the Iconic Therapy for Borderline Personality Disorder Symptoms
Official Title
Effectiveness of the Iconic Therapy in Youth With Suicidal Ideation/Self-injuring Behavior and Borderline Personality Traits: Study Protocol for a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Silvia Elisa Hurtado Santiago

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Personality Disorder, Borderline
Keywords
Terapia Iconica, BPD, adolescence, suicide

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iconic Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Support therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Emotional regulation
Intervention Description
Educate people with difficulty in regulating their emotions and help them acquire skills to do so
Primary Outcome Measure Information:
Title
Change on the severity of borderline personality disorder measured by Borderline Personality Symptom List (BSL-23).
Description
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.
Time Frame
Baseline and up to 12 months after inclusion.
Secondary Outcome Measure Information:
Title
Sociodemographic variables
Description
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.
Time Frame
Baseline
Title
Change on the suicidal ideation and behavior measured by the Columbia Suicide History Form (SSRS).
Description
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.
Time Frame
Baseline and up to 12 months after inclusion.
Title
Change on non-suicidal self-injure diagnosis
Description
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.
Time Frame
Baseline and up to 12 months after inclusion.
Title
Change on the economic evaluation measured by the Client Service Receipt Inventory (CSRI) - adapted Spanish version (CSRI-Spanish version)
Description
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).
Time Frame
Baseline and up to 12 months after inclusion.
Other Pre-specified Outcome Measures:
Title
Change on the maladjustment to the daily life measured by the Maladjustment Scale (EI).
Description
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.
Time Frame
Baseline and up to 12 months after inclusion.
Title
Satisfaction with the treatment assessed by the Opinion of treatment scale (OTS).
Description
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).
Time Frame
Through therapy completion, an average of 12 weeks.
Title
Change on the perceived subjective global improvement measured on a 7-point ad hoc Likert scale
Description
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.
Time Frame
Through therapy completion (an average of 12 weeks) and up to 12 months after inclusion
Title
Change on family and friends´ perceived global improvement
Description
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.
Time Frame
Through therapy completion (an average of 12 weeks) and up to 12 months after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosa Bersabé, Psychologist
Organizational Affiliation
Malaga University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fermín Mayoral, Psychiatrist
Organizational Affiliation
Hospital Regional de Malaga
Official's Role
Study Director
Facility Information:
Facility Name
Silvia E. Hurtado-Santiago
City
Malaga
ZIP/Postal Code
29190
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35351048
Citation
Hurtado-Santiago S, Guzman-Parra J, Mayoral F, Bersabe RM. Iconic Therapy for the reduction of borderline personality disorder symptoms among suicidal youth: a preliminary study. BMC Psychiatry. 2022 Mar 29;22(1):224. doi: 10.1186/s12888-022-03862-x.
Results Reference
derived
PubMed Identifier
33884617
Citation
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
Results Reference
derived
PubMed Identifier
32368793
Citation
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.
Results Reference
derived
PubMed Identifier
30176878
Citation
Hurtado-Santiago S, Guzman-Parra J, Bersabe RM, Mayoral F. Effectiveness of iconic therapy for the reduction of borderline personality disorder symptoms among suicidal youth: study protocol for a randomised controlled trial. BMC Psychiatry. 2018 Sep 3;18(1):277. doi: 10.1186/s12888-018-1857-x.
Results Reference
derived

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Effectiveness of the Iconic Therapy for Borderline Personality Disorder Symptoms

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