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ERGT for Women Engaging in NSSI - an Effectiveness Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01986257
Enrollment
97
Registered
2013-11-18
Start date
2013-10-31
Completion date
2015-03-31
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALEmotion Regulation Group Therapy (ERGT).

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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.
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.
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.
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.
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.
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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026