Effectiveness of the Iconic Therapy for Borderline Personality Disorder Symptoms

Personality Disorder, Borderline Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03011190
• Other study ID #: shs-ico-2015-01
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: December 2017

Study information

• Verified date: May 2018
• Source: University of Malaga
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 25 Years

Eligibility

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)

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorder, Borderline
• Personality Disorders

Intervention

Behavioral:
• Emotional regulation
Educate people with difficulty in regulating their emotions and help them acquire skills to do so

Locations

Country	Name	City	State
Spain	Silvia E. Hurtado-Santiago	Malaga

Sponsors (1)

Lead Sponsor	Collaborator
Silvia Elisa Hurtado Santiago

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change on the maladjustment to the daily life measured by the Maladjustment Scale (EI).	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.
Other	Satisfaction with the treatment assessed by the Opinion of treatment scale (OTS).	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.
Other	Change on the perceived subjective global improvement measured on a 7-point ad hoc Likert scale	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
Other	Change on family and friends´ perceived global improvement	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
Primary	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	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.	Baseline
Secondary	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.	Baseline and up to 12 months after inclusion.
Secondary	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.	Baseline and up to 12 months after inclusion.
Secondary	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).	Baseline and up to 12 months after inclusion.