ERGT for Women Engaging in NSSI - an Effectiveness Study

Borderline Personality Disorder Clinical Trial

Official title:

Emotion Regulation Group Therapy (ERGT) for Women Engaging in Non-suicidal Self-Injury (NSSI) - an Effectiveness Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01986257
• Other study ID #: DNR 2013/1321-31/3
• Status: Completed
• Phase: N/A
• First received: November 4, 2013
• Last updated: November 2, 2017
• Start date: October 2013
• Est. completion date: March 2015

Study information

• Verified date: November 2017
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary aim is to investigate the effectiveness of Emotion Regulation Group Therapy (ERGT) for women who self-harm in ordinary psychiatric outpatient health care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: March 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• NSSI a minimum of three times in the last six months

• Meets at least three criteria for Borderline Personality Disorder according to DSM-IV-TR

• Contact with an other individual therapist, psychiatrist, "case manager" or equal

Exclusion Criteria:

• Insertion/withdrawal of psychopharmacological substances within two months prior to the treatment

• Other acute primary axis I diagnosis (e.g. anorexia nervosa) that demand treatment in first hand

• Bipolar disorder I or primary psychosis

• Current substance dependence (the last month)

• Current life circumstances that would hinder the treatment (i.e. ongoing domestic abuse)

• Insufficient Swedish language skills

• Cocurrent treatment with Mentalization based therapy (MBT) or Dialectical behavioral therapy (DBT)

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Non-suicidal Self-injury (NSSI)
• Personality Disorders

Intervention

Behavioral:
• Emotion Regulation Group Therapy (ERGT).

Locations

Country	Name	City	State
Sweden	Centre for Psychiatry Research Karolinska Institutet and Stockholm County Council	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of non-suicidal self-injury as measured by Deliberate Self-Harm Inventory (DSHI)	Change from Baseline in deliberate self-harm after 14 weeks and at 6- and 12 months after treatment has ended.	Baseline (from inclusion to treatment start), (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (14 weeks) and six and twelve months follow-up.
Secondary	Borderline Symptom List Behavior supplement (BSL-supplement)	Change from Baseline in self-destructive behaviors after 14 weeks and at 6- and 12 months after treatment has ended.	Baseline (from inclusion to treatment start), pre-treatment (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (14 weeks), and six and twelve months follow-up.
Secondary	Difficulties in Emotion Regulation Scale (DERS)	Change from Baseline in difficulties with emotion regulation after 14 weeks and at 6- and 12 months after treatment has ended.	Baseline (from inclusion to treatment start), pre-treatment (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (14 weeks) and six and twelve months follow-up.
Secondary	Diary questionnaire (DQ)	Change from Baseline in positive and negative affect after 14 weeks and at 6- and 12 months after treatment has ended.	Baseline (from inclusion to treatment start), pre-treatment (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (14 weeks) and six and twelve months follow-up.
Secondary	The Borderline Evaluation of Severity over Time (BEST).	Change from Baseline in Borderline severity symptoms after 14 weeks and at 6- and 12 months after treatment has ended.	Pre-treatment (7 days prior to treatment start), post-treatment (14 weeks) and six and twelve months follow-up.
Secondary	The Depression Anxiety Stress Scales (DASS)	Change from Baseline in depression and anxiety after 14 weeks and at 6- and 12 months after treatment has ended.	Pre-treatment (7 days prior to treatment start), post-treatment (14 weeks) and six and twelve months follow-up.
Secondary	Inventory of Interpersonal Problems - Borderline Personality Disorder (IIP-BPD)	Change from Baseline in interpersonal problems after 14 weeks and at 6- and 12 months after treatment has ended.	Pre-treatment (7 days prior to treatment start), post-treatment (14 weeks) and six and twelve months follow-up.
Secondary	Sheehan Disability Scale (SDS)	Change from Baseline in global functioning after 14 weeks and at 6- and 12 months after treatment has ended.	Pre-treatment (7 days prior to treatment start), post-treatment (14 weeks) and six and twelve months follow-up.
Secondary	Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)	Change from Baseline in societal costs after 14 weeks and at 6- and 12 months after treatment has ended.	Baseline, post-treatment (14 weeks) and six and twelve months follow-up.
Secondary	Euroqol-5D (EQ-5D)	Change from Baseline in quality of life after 14 weeks and at 6- and 12 months after treatment has ended.	Baseline, post-treatment (14 weeks) and six and twelve months follow-up.