ERGT for Women Engaging in NSSI - an Effectiveness Study

Not Applicable

Completed

• Conditions: Borderline Personality Disorder; Non-suicidal Self-injury (NSSI)

• Registration Number: NCT01986257
• Lead Sponsor: Karolinska Institutet

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-04
• Study First Submitted QC: 2013-11-11
• Study First Posted: 2013-11-18
• Primary Completion: 2014-07
• Study Completion: 2015-03
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-02
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 97

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Frequency of non-suicidal self-injury as measured by Deliberate Self-Harm Inventory (DSHI)	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.	Change from Baseline in deliberate self-harm after 14 weeks and at 6- and 12 months after treatment has ended.

Secondary Outcome Measures

Name	Time	Method
Diary questionnaire (DQ)	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.	Change from Baseline in positive and negative affect after 14 weeks and at 6- and 12 months after treatment has ended.
Borderline Symptom List Behavior supplement (BSL-supplement)	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.	Change from Baseline in self-destructive behaviors after 14 weeks and at 6- and 12 months after treatment has ended.
Difficulties in Emotion Regulation Scale (DERS)	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.	Change from Baseline in difficulties with emotion regulation after 14 weeks and at 6- and 12 months after treatment has ended.
The Borderline Evaluation of Severity over Time (BEST).	Pre-treatment (7 days prior to treatment start), post-treatment (14 weeks) and six and twelve months follow-up.	Change from Baseline in Borderline severity symptoms after 14 weeks and at 6- and 12 months after treatment has ended.
The Depression Anxiety Stress Scales (DASS)	Pre-treatment (7 days prior to treatment start), post-treatment (14 weeks) and six and twelve months follow-up.	Change from Baseline in depression and anxiety after 14 weeks and at 6- and 12 months after treatment has ended.
Inventory of Interpersonal Problems - Borderline Personality Disorder (IIP-BPD)	Pre-treatment (7 days prior to treatment start), post-treatment (14 weeks) and six and twelve months follow-up.	Change from Baseline in interpersonal problems after 14 weeks and at 6- and 12 months after treatment has ended.
Euroqol-5D (EQ-5D)	Baseline, post-treatment (14 weeks) and six and twelve months follow-up.	Change from Baseline in quality of life after 14 weeks and at 6- and 12 months after treatment has ended.
Sheehan Disability Scale (SDS)	Pre-treatment (7 days prior to treatment start), post-treatment (14 weeks) and six and twelve months follow-up.	Change from Baseline in global functioning after 14 weeks and at 6- and 12 months after treatment has ended.
Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)	Baseline, post-treatment (14 weeks) and six and twelve months follow-up.	Change from Baseline in societal costs after 14 weeks and at 6- and 12 months after treatment has ended.

Trial Locations

Locations (1)

Centre for Psychiatry Research Karolinska Institutet and Stockholm County Council; 🇸🇪 Stockholm, Sweden