Clinical trial NCT01986257: ERGT for Women Engaging in NSSI - an Effectiveness Study
Official title: Emotion Regulation Group Therapy (ERGT) for Women Engaging in Non-suicidal Self-Injury (NSSI) - an Effectiveness Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Non-suicidal Self-injury (NSSI)
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2013-11-18
Enrollment: 97
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Frequency of non-suicidal self-injury as measured by Deliberate Self-Harm Inventory (DSHI)
timeFrame: 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 outcomes:
measure: Borderline Symptom List Behavior supplement (BSL-supplement)
timeFrame: 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.
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 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.
measure: Diary questionnaire (DQ)
timeFrame: 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.
measure: The Borderline Evaluation of Severity over Time (BEST).
timeFrame: Pre-treatment (7 days prior to treatment start), post-treatment (14 weeks) and six and twelve months follow-up.
measure: The Depression Anxiety Stress Scales (DASS)
timeFrame: Pre-treatment (7 days prior to treatment start), post-treatment (14 weeks) and six and twelve months follow-up.
measure: Inventory of Interpersonal Problems - Borderline Personality Disorder (IIP-BPD)
timeFrame: Pre-treatment (7 days prior to treatment start), post-treatment (14 weeks) and six and twelve months follow-up.
measure: Sheehan Disability Scale (SDS)
timeFrame: Pre-treatment (7 days prior to treatment start), post-treatment (14 weeks) and six and twelve months follow-up.
measure: Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)
timeFrame: Baseline, post-treatment (14 weeks) and six and twelve months follow-up.
measure: Euroqol-5D (EQ-5D)
timeFrame: Baseline, post-treatment (14 weeks) and six and twelve months follow-up.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Centre for Psychiatry Research Karolinska Institutet and Stockholm County Council
Study officials:
References:
citation: Sahlin H, Bjureberg J, Gratz KL, Tull MT, Hedman E, Bjarehed J, Jokinen J, Lundh LG, Ljotsson B, Hellner C. Emotion regulation group therapy for deliberate self-harm: a multi-site evaluation in routine care using an uncontrolled open trial design. BMJ Open. 2017 Oct 5;7(10):e016220. doi: 10.1136/bmjopen-2017-016220.