Borderline Personality DisorderNCT01986257
ERGT for Women Engaging in NSSI - an Effectiveness Study
A study testing Emotion Regulation Group Therapy (ERGT). in people with Borderline Personality Disorder and Non-suicidal Self-injury (NSSI), run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Borderline Personality Disorder, Non-suicidal Self-injury (NSSI)
- What is being tested?
- Emotion Regulation Group Therapy (ERGT).
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Centre for Psychiatry Research Karolinska Institutet and Stockholm County Council
Stockholm, 113 64
About this study
Official title: 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.
- Being tested
- Emotion Regulation Group Therapy (ERGT).
- Medical subject headings
- Borderline Personality Disorder, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion Regulation Group Therapy (ERGT).Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Emotion Regulation Group Therapy (ERGT). | Experimental | Not described Receives: Behavioral: Emotion Regulation Group Therapy (ERGT). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Change from Baseline in self-destructive behaviors after 14 weeks and at 6- and 12 months after treatment has ended.
Measured: 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)
Change from Baseline in difficulties with emotion regulation after 14 weeks and at 6- and 12 months after treatment has ended.
Measured: 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)
Change from Baseline in positive and negative affect after 14 weeks and at 6- and 12 months after treatment has ended.
Measured: 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).
Change from Baseline in Borderline severity symptoms after 14 weeks and at 6- and 12 months after treatment has ended.
Measured: 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)
Change from Baseline in depression and anxiety after 14 weeks and at 6- and 12 months after treatment has ended.
Measured: 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)
Change from Baseline in interpersonal problems after 14 weeks and at 6- and 12 months after treatment has ended.
Measured: Pre-treatment (7 days prior to treatment start), post-treatment (14 weeks) and six and twelve months follow-up.
Sheehan Disability Scale (SDS)
Change from Baseline in global functioning after 14 weeks and at 6- and 12 months after treatment has ended.
Measured: 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)
Change from Baseline in societal costs after 14 weeks and at 6- and 12 months after treatment has ended.
Measured: Baseline, post-treatment (14 weeks) and six and twelve months follow-up.
Euroqol-5D (EQ-5D)
Change from Baseline in quality of life after 14 weeks and at 6- and 12 months after treatment has ended.
Measured: Baseline, post-treatment (14 weeks) and six and twelve months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clara Hellner Gumpert, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986257
- Sponsor's protocol ID
- DNR 2013/1321-31/3
- Status last verified
- Nov 2017
- First submitted
- 4 Nov 2013
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28982814
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion Regulation Group Therapy (ERGT) for Women Engaging in Non-suicidal Self-Injury (NSSI) - an Effectiveness Study
- ClinicalTrials.gov ID
- NCT01986257
- Acronym / sponsor ID
- DNR 2013/1321-31/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Jul 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 18 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emotion Regulation Group Therapy (ERGT). | Experimental | Behavioral: Emotion Regulation Group Therapy (ERGT). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotion Regulation Group Therapy (ERGT). | Behavioural | Emotion Regulation Group Therapy (ERGT). |
Primary outcome
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.
9 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
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.
Euroqol-5D (EQ-5D)
Time frame: Baseline, post-treatment (14 weeks) and six and twelve months follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Derived from this study: PubMed 28982814Sahlin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion Regulation Group Therapy (ERGT). in people with Borderline Personality Disorder and Non-suicidal Self-injury (NSSI), run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01986257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.