Clinical trial NCT03011190: 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
Overall status: COMPLETED
Phase: NA
Conditions: Personality Disorder, Borderline
Keywords: Terapia Iconica
BPD
adolescence
suicide
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Change on the severity of borderline personality disorder measured by Borderline Personality Symptom List (BSL-23).
timeFrame: Baseline and up to 12 months after inclusion.
Secondary outcomes:
measure: Sociodemographic variables
timeFrame: Baseline
measure: Change on the suicidal ideation and behavior measured by the Columbia Suicide History Form (SSRS).
timeFrame: Baseline and up to 12 months after inclusion.
measure: Change on non-suicidal self-injure diagnosis
timeFrame: Baseline and up to 12 months after inclusion.
measure: Change on the economic evaluation measured by the Client Service Receipt Inventory (CSRI) - adapted Spanish version (CSRI-Spanish version)
timeFrame: Baseline and up to 12 months after inclusion.
Other outcomes:
measure: Change on the maladjustment to the daily life measured by the Maladjustment Scale (EI).
timeFrame: Baseline and up to 12 months after inclusion.
measure: Satisfaction with the treatment assessed by the Opinion of treatment scale (OTS).
timeFrame: Through therapy completion, an average of 12 weeks.
measure: Change on the perceived subjective global improvement measured on a 7-point ad hoc Likert scale
timeFrame: Through therapy completion (an average of 12 weeks) and up to 12 months after inclusion
measure: Change on family and friends´ perceived global improvement
timeFrame: Through therapy completion (an average of 12 weeks) and up to 12 months after inclusion
Locations:
city: Malaga
country: Spain
facility: Silvia E. Hurtado-Santiago
Study officials:
affiliation: Malaga University
name: Rosa Bersabé, Psychologist
role: STUDY_CHAIR
affiliation: Hospital Regional de Malaga
name: Fermín Mayoral, Psychiatrist
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.