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ERGT for Women Engaging in NSSI - an Effectiveness Study

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ClinicalTrials.gov Identifier: NCT01986257
Recruitment Status : Completed
First Posted : November 18, 2013
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Clara Hellner Gumpert, Karolinska Institutet

Study Description
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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.

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Non-suicidal Self-injury (NSSI) Behavioral: Emotion Regulation Group Therapy (ERGT). Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Emotion Regulation Group Therapy (ERGT) for Women Engaging in Non-suicidal Self-Injury (NSSI) - an Effectiveness Study
Actual Study Start Date : October 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Self-Harm

Arms and Interventions
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Arm Intervention/treatment
Experimental: Emotion Regulation Group Therapy (ERGT). Behavioral: Emotion Regulation Group Therapy (ERGT).


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of non-suicidal self-injury as measured by Deliberate Self-Harm Inventory (DSHI) [ Time Frame: 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 :
  1. Borderline Symptom List Behavior supplement (BSL-supplement) [ Time Frame: 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.

  2. Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 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.

  3. Diary questionnaire (DQ) [ Time Frame: 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.

  4. The Borderline Evaluation of Severity over Time (BEST). [ Time Frame: 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.

  5. The Depression Anxiety Stress Scales (DASS) [ Time Frame: 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.

  6. Inventory of Interpersonal Problems - Borderline Personality Disorder (IIP-BPD) [ Time Frame: 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.

  7. Sheehan Disability Scale (SDS) [ Time Frame: 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.

  8. Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) [ Time Frame: 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.

  9. Euroqol-5D (EQ-5D) [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986257


Locations
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Sweden
Centre for Psychiatry Research Karolinska Institutet and Stockholm County Council
Stockholm, Sweden, 113 64
Sponsors and Collaborators
Karolinska Institutet
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Clara Hellner Gumpert, Ph.D., Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01986257    
Other Study ID Numbers: DNR 2013/1321-31/3
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Personality Disorders
Borderline Personality Disorder
Self-Injurious Behavior
Mental Disorders
Behavioral Symptoms