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ERGT for Women Engaging in NSSI - an Effectiveness Study

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Emotion Regulation Group Therapy (ERGT).

About this trial

This is an interventional treatment trial for Borderline Personality Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

Centre for Psychiatry Research Karolinska Institutet and Stockholm County Council

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Emotion Regulation Group Therapy (ERGT).

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Borderline Symptom List Behavior supplement (BSL-supplement)

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)

Change from Baseline in difficulties with emotion regulation after 14 weeks and at 6- and 12 months after treatment has ended.

Diary questionnaire (DQ)

Change from Baseline in positive and negative affect after 14 weeks and at 6- and 12 months after treatment has ended.

The Borderline Evaluation of Severity over Time (BEST).

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)

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)

Change from Baseline in interpersonal problems after 14 weeks and at 6- and 12 months after treatment has ended.

Sheehan Disability Scale (SDS)

Change from Baseline in global functioning after 14 weeks and at 6- and 12 months after treatment has ended.

Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)

Change from Baseline in societal costs after 14 weeks and at 6- and 12 months after treatment has ended.

Euroqol-5D (EQ-5D)

Change from Baseline in quality of life after 14 weeks and at 6- and 12 months after treatment has ended.

Full Information

NCT ID

NCT01986257

First Posted

November 4, 2013

Last Updated

November 2, 2017

Sponsor

Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT01986257

Brief Title

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

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

October 2013 (Actual)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

97 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Emotion Regulation Group Therapy (ERGT).

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Emotion Regulation Group Therapy (ERGT).

Primary Outcome Measure Information:

Title

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

Description

Change from Baseline in deliberate self-harm after 14 weeks and at 6- and 12 months after treatment has ended.

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.

Secondary Outcome Measure Information:

Title

Borderline Symptom List Behavior supplement (BSL-supplement)

Description

Change from Baseline in self-destructive behaviors after 14 weeks and at 6- and 12 months after treatment has ended.

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.

Title

Difficulties in Emotion Regulation Scale (DERS)

Description

Change from Baseline in difficulties with emotion regulation after 14 weeks and at 6- and 12 months after treatment has ended.

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.

Title

Diary questionnaire (DQ)

Description

Change from Baseline in positive and negative affect after 14 weeks and at 6- and 12 months after treatment has ended.

Time Frame

Title

The Borderline Evaluation of Severity over Time (BEST).

Description

Change from Baseline in Borderline severity symptoms after 14 weeks and at 6- and 12 months after treatment has ended.

Time Frame

Pre-treatment (7 days prior to treatment start), post-treatment (14 weeks) and six and twelve months follow-up.

Title

The Depression Anxiety Stress Scales (DASS)

Description

Change from Baseline in depression and anxiety after 14 weeks and at 6- and 12 months after treatment has ended.

Time Frame

Pre-treatment (7 days prior to treatment start), post-treatment (14 weeks) and six and twelve months follow-up.

Title

Inventory of Interpersonal Problems - Borderline Personality Disorder (IIP-BPD)

Description

Change from Baseline in interpersonal problems after 14 weeks and at 6- and 12 months after treatment has ended.

Time Frame

Pre-treatment (7 days prior to treatment start), post-treatment (14 weeks) and six and twelve months follow-up.

Title

Sheehan Disability Scale (SDS)

Description

Change from Baseline in global functioning after 14 weeks and at 6- and 12 months after treatment has ended.

Time Frame

Pre-treatment (7 days prior to treatment start), post-treatment (14 weeks) and six and twelve months follow-up.

Title

Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)

Description

Change from Baseline in societal costs after 14 weeks and at 6- and 12 months after treatment has ended.

Time Frame

Baseline, post-treatment (14 weeks) and six and twelve months follow-up.

Title

Euroqol-5D (EQ-5D)

Description

Change from Baseline in quality of life after 14 weeks and at 6- and 12 months after treatment has ended.

Time Frame

Baseline, post-treatment (14 weeks) and six and twelve months follow-up.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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)

Facility Information:

Facility Name

Centre for Psychiatry Research Karolinska Institutet and Stockholm County Council

City

Stockholm

ZIP/Postal Code

113 64

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

28982814

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. Erratum In: BMJ Open. 2017 Nov 3;7(11):e016220corr1.

Results Reference

derived

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