NCT02697019

Brief Summary

The primary aim is to investigate the effectiveness of an Internet-delivered Emotion Regulation Individual Therapy for Adolescents (ERITA) with nonsuicidal self-injury (NSSI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

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

February 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

1.8 years

First QC Date

February 26, 2016

Last Update Submit

August 9, 2018

Conditions

Nonsuicidal Self-Injury

Keywords

Nonsuicidal Self-Injury (NSSI), Deliberate Self-Harm (DSH), Self-harm, Self-injury

Outcome Measures

Primary Outcomes (1)

  • Deliberate Self-Harm Inventory - 9 item version

    Change from baseline in self-harming behaviors when measures weekly, after 12 weeks, and at 3 and 6 months after treatment has ended

    Baseline (30 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks), and three and six months follow-up

Secondary Outcomes (7)

  • Borderline Symptom List Behavior supplement (BSL-supplement)

    Baseline (30 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks), and three and six months follow-up

  • Difficulties in Emotion Regulation Scale -16 item version (DERS-16)

    Baseline (30 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks), and three and six months follow-up

  • Difficulties in Emotion Regulation Scale (DERS)

    Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]

  • Borderline personality features in childhood (BPFS-C)

    Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]

  • The Revised Child Anxiety and Depression Scale - Child and Parent rated (RCADS-C)

    Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]

  • +2 more secondary outcomes

Other Outcomes (8)

  • The treatment credibility scale

    One week after treatment start

  • Working Alliance Inventory (WAI) short version

    Three weeks after treatment start

  • The Client Satisfaction Questionnaire (CSQ)

    Twelve weeks after treatment start

  • +5 more other outcomes

Study Arms (1)

Internet-delivered ERITA

EXPERIMENTAL
Behavioral: Internet-delivered Emotion Regulation Individual Therapy for Adolescents

Interventions

Internet-delivered Emotion Regulation Individual Therapy for AdolescentsBEHAVIORAL
Internet-delivered ERITA

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • A primary diagnosis of NSSI as defined in Section 3 in the fifth edition of the Diagnostic and Statistical Manual 5 of the American Psychiatric Association (DSM-5) \< 1 NSSI episode during the past month At least one parent needs to commit to participate in the parent program

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, 113 64, Sweden

Location

Related Publications (1)

  • Bjureberg J, Sahlin H, Hedman-Lagerlof E, Gratz KL, Tull MT, Jokinen J, Hellner C, Ljotsson B. Extending research on Emotion Regulation Individual Therapy for Adolescents (ERITA) with nonsuicidal self-injury disorder: open pilot trial and mediation analysis of a novel online version. BMC Psychiatry. 2018 Oct 11;18(1):326. doi: 10.1186/s12888-018-1885-6.

    PMID: 30305103DERIVED

MeSH Terms

Conditions

Self-Injurious BehaviorDyschromatosis symmetrica hereditaria 1

Condition Hierarchy (Ancestors)

Behavioral 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
PhD

Study Record Dates

First Submitted

February 26, 2016

First Posted

March 2, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations

SE(1)