Nonsuicidal Self-InjuryNCT02326012
Emotion Regulation Individual Therapy for Adolescents With NSSI - An Open Pilot Study
A study testing Emotion Regulation Individual Therapy for Adolescents in people with Nonsuicidal Self-Injury, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The primary aim is to investigate the effectiveness of Emotion Regulation Individual Therapy for Adolescents (ERITA) who self-harm. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Nonsuicidal Self-Injury
- What is being tested?
- Emotion Regulation Individual Therapy for Adolescents
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2014to Jan 2016
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- a primary diagnosis of NSSI as defined by DSM-5 Section 3
- < 1 NSSI episode during the past month
- at least one parent needs to commit to participate in the parent program
Who cannot join
- bipolar disorder I or primary psychosis
- severe suicidal ideation
- ongoing substance dependence
- 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
- 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.
About this study
The primary aim is to investigate the effectiveness of Emotion Regulation Individual Therapy for Adolescents (ERITA) who self-harm.
- Conditions
- Nonsuicidal Self-Injury
- Being tested
- Emotion Regulation Individual Therapy for Adolescents
- Medical subject headings
- Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion Regulation Individual Therapy for AdolescentsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Emotion Regulation Individual Therapy for Adolescents | Experimental | Not described Receives: Behavioral: Emotion Regulation Individual Therapy for Adolescents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deliberate Self-Harm Inventory - 9 item version
Change from baseline in self-harming behaviors when measures weekly, after 12 weeks and at 6 months after treatment has ended.
Measured: Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up
Secondary outcomes (8)
Borderline Symptom List Behavior supplement (BSL-supplement)
Change from baseline in self-destructive and risky behaviors when measures weekly, after 12 weeks and at 6 months after treatment has ended.
Measured: Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up
Difficulties in Emotion Regulation Scale -16 item version (DERS-16)
Change from baseline in difficulties in emotion regulation when measures weekly, after 12 weeks and at 6 months after treatment has ended.
Measured: Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up
Diary questionnaire (DQ)
Change from baseline in difficulties in emotion regulation when measures weekly, after 12 weeks and at 6 months after treatment has ended.
Measured: Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up
Difficulties in Emotion Regulation Scale (DERS)
Change from baseline in difficulties in emotion regulation after 12 weeks and at 6 months after treatment has ended.
Measured: Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
Strengths and Difficulties Questionnaire Child and Parent version (SDQ-C/P)
Change from baseline in strengths and difficulties after 12 weeks and at 6 months after treatment has ended.
Measured: Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
Borderline personality features in childhood (BPFS-C)
Change from baseline in borderline personality features after 12 weeks and at 6 months after treatment has ended.
Measured: Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
The alcohol use disorders identification test - C (AUDIT-C)
Change from baseline in alcohol use after 12 weeks and at 6 months after treatment has ended.
Measured: Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
Evaluation of the Drug Use Disorders Identification Test - C (DUDIT-C)
Change from baseline in drug use after 12 weeks and at 6 months after treatment has ended.
Measured: Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six 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 posted25 Dec 2014 (estimated)
- Study startMar 2014
- Primary completionJan 2016
- Study completionJan 2016
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 Nonsuicidal Self-InjuryStudies 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
- 17 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
- NCT02326012
- Sponsor's protocol ID
- 2014/1-31/3
- Status last verified
- Jan 2016
- First submitted
- 22 Dec 2014
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bjureberg J, Sahlin H, Hellner C, Hedman-Lagerlof E, Gratz KL, Bjarehed J, Jokinen J, Tull MT, Ljotsson B. Emotion regulation individual therapy for adolescents with nonsuicidal self-injury disorder: a feasibility study. BMC Psychiatry. 2017 Dec 28;17(1):411. doi: 10.1186/s12888-017-1527-4.
PubMed 29282024
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion Regulation Individual Therapy for Adolescents With NSSI - An Open Pilot Study
- ClinicalTrials.gov ID
- NCT02326012
- Acronym / sponsor ID
- 2014/1-31/3
- Conditions
- Nonsuicidal Self-Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 25 Dec 2014 (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 Individual Therapy for Adolescents (ERITA) who self-harm.
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 Individual Therapy for Adolescents | Experimental | Behavioral: Emotion Regulation Individual Therapy for Adolescents |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- a primary diagnosis of NSSI as defined by DSM-5 Section 3
- < 1 NSSI episode during the past month
- at least one parent needs to commit to participate in the parent program
Key exclusion criteria (8 listed)
- bipolar disorder I or primary psychosis
- severe suicidal ideation
- ongoing substance dependence
- 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
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 Individual Therapy for Adolescents | Behavioural | Emotion Regulation Individual Therapy for Adolescents |
Primary outcome
Deliberate Self-Harm Inventory - 9 item version
Time frame: Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up
Change from baseline in self-harming behaviors when measures weekly, after 12 weeks and at 6 months after treatment has ended.
8 secondary outcomes
Borderline Symptom List Behavior supplement (BSL-supplement)
Time frame: Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up
Difficulties in Emotion Regulation Scale -16 item version (DERS-16)
Time frame: Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up
Diary questionnaire (DQ)
Time frame: Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
Strengths and Difficulties Questionnaire Child and Parent version (SDQ-C/P)
Time frame: Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
Borderline personality features in childhood (BPFS-C)
Time frame: Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
The alcohol use disorders identification test - C (AUDIT-C)
Time frame: Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
Evaluation of the Drug Use Disorders Identification Test - C (DUDIT-C)
Time frame: Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six 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 5 Jan 2016.
- Derived from this study: PubMed 29282024Bjureberg J, Sahlin H, Hellner C, Hedman-Lagerlof E, Gratz KL, Bjarehed J, Jokinen J, Tull MT, Ljotsson B. Emotion regulation individual therapy for adolescents with nonsuicidal self-injury disorder: a feasibility study. BMC Psychiatry. 2017 Dec 28;17(1):411. doi: 10.1186/s12888-017-1527-4.
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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 Individual Therapy for Adolescents in people with Nonsuicidal Self-Injury, 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 8 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 5 Jan 2016. 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?
Deliberate Self-Harm Inventory - 9 item version (time frame: Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six 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 NCT02326012, 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 5 Jan 2016.