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Completed

NCT Number: NCT01986257

ERGT for Women Engaging in NSSI - an Effectiveness Study

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.

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Key information

Conditions

Borderline Personality Disorder Behavior Behavioral Symptoms Mental Disorders Non-suicidal Self-injury (NSSI) Personality Disorders Self-Injurious Behavior

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Psychiatry Research Karolinska Institutet and Stockholm County Council

Stockholm, 113 64, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Emotion Regulation Group Therapy (ERGT).

Behavioral

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Nov 18, 2013
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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