NCT01986257

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 4, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 18, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

9 months

First QC Date

November 4, 2013

Last Update Submit

November 2, 2017

Conditions

Borderline Personality DisorderNon-suicidal Self-injury (NSSI)

Outcome Measures

Primary Outcomes (1)

  • Frequency of non-suicidal self-injury as measured by Deliberate Self-Harm Inventory (DSHI)

    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 Outcomes (9)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • +4 more secondary outcomes

Study Arms (1)

Emotion Regulation Group Therapy (ERGT).

EXPERIMENTAL
Behavioral: Emotion Regulation Group Therapy (ERGT).

Interventions

Emotion Regulation Group Therapy (ERGT).BEHAVIORAL
Emotion Regulation Group Therapy (ERGT).

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Psychiatry Research Karolinska Institutet and Stockholm County Council

Stockholm, 113 64, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 28982814DERIVED

MeSH Terms

Conditions

Borderline Personality DisorderSelf-Injurious Behavior

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

November 4, 2013

First Posted

November 18, 2013

Study Start

October 1, 2013

Primary Completion

July 1, 2014

Study Completion

March 1, 2015

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations

SE(1)