ERGT for Women Engaging in NSSI - an Effectiveness Study

November 2, 2017 updated by: Clara Hellner Gumpert, Karolinska Institutet

Emotion Regulation Group Therapy (ERGT) for Women Engaging in Non-suicidal Self-Injury (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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 113 64
        • Centre for Psychiatry Research Karolinska Institutet and Stockholm County Council

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Emotion Regulation Group Therapy (ERGT).
Behavioral: Emotion Regulation Group Therapy (ERGT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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)
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.
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)
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.
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).
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.
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)
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.
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)
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.
Pre-treatment (7 days prior to treatment start), post-treatment (14 weeks) and six and twelve months follow-up.
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.
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)
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.
Baseline, post-treatment (14 weeks) and six and twelve months follow-up.
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.
Baseline, post-treatment (14 weeks) and six and twelve months follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2013

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

November 4, 2013

First Submitted That Met QC Criteria

November 11, 2013

First Posted (ESTIMATE)

November 18, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 2, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DNR 2013/1321-31/3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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