Effectiveness of the Iconic Therapy for Borderline Personality Disorder Symptoms

NCT03011190 | Completed

• 1 other identifier: shs-ico-2015-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Personality Disorder, Borderline

Keywords

Terapia Iconica; BPD; adolescence; suicide

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and up to 12 months after inclusion.

Secondary Outcomes (4)

• Sociodemographic variables

  Baseline

• Change on the suicidal ideation and behavior measured by the Columbia Suicide History Form (SSRS).

  Baseline and up to 12 months after inclusion.

• Change on non-suicidal self-injure diagnosis

  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)

  Baseline and up to 12 months after inclusion.

Other Outcomes (4)

• Change on the maladjustment to the daily life measured by the Maladjustment Scale (EI).

  Baseline and up to 12 months after inclusion.

• Satisfaction with the treatment assessed by the Opinion of treatment scale (OTS).

  Through therapy completion, an average of 12 weeks.

• Change on the perceived subjective global improvement measured on a 7-point ad hoc Likert scale

  Through therapy completion (an average of 12 weeks) and up to 12 months after inclusion

Study Arms (2)

Iconic Therapy

EXPERIMENTAL

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

Support therapy

ACTIVE COMPARATOR

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

Interventions

Emotional regulation BEHAVIORAL

Educate people with difficulty in regulating their emotions and help them acquire skills to do so

Iconic Therapy; Support therapy

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Silvia Elisa Hurtado Santiago: lead

Study Sites (1)

Silvia E. Hurtado-Santiago

Málaga, 29190, Spain

Location

Related Publications (4)

• 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.

  PMID: 35351048 DERIVED

• 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.

  PMID: 33884617 DERIVED

• 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.

  PMID: 32368793 DERIVED

• 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.

  PMID: 30176878 DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder; Suicide

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Rosa Bersabé, Psychologist

  Malaga University

  STUDY CHAIR

• Fermín Mayoral, Psychiatrist

  Hospital Regional de Malaga

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: January 5, 2017
• Study Start: September 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 15, 2018

Record last verified: 2018-05

Locations

ES (1)