ERGT for Women Engaging in NSSI - an Effectiveness Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Borderline Personality Disorder, Non-suicidal Self-injury (NSSI)

Intervention / Treatment
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* Behavioral: Emotion Regulation Group Therapy (ERGT).


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Emotion Regulation Group Therapy (ERGT).<br> | Behavioral: Emotion Regulation Group Therapy (ERGT).<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. |