NCT02326012

Brief Summary

The primary aim is to investigate the effectiveness of Emotion Regulation Individual Therapy for Adolescents (ERITA) who self-harm.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

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

March 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 25, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

1.8 years

First QC Date

December 22, 2014

Last Update Submit

January 3, 2016

Conditions

Nonsuicidal 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 6 months after treatment has ended.

    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)

    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)

    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)

    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)

    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)

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

  • +3 more secondary outcomes

Other Outcomes (6)

  • Euroqol-5D (EQ-5D)

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

  • Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (TiC-P)

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

  • Patient Health Questionnaire (PHQ9)

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

  • +3 more other outcomes

Study Arms (1)

Emotion Regulation Individual Therapy for Adolescents

EXPERIMENTAL
Behavioral: Emotion Regulation Individual Therapy for Adolescents

Interventions

Emotion Regulation Individual Therapy for AdolescentsBEHAVIORAL
Emotion Regulation Individual Therapy for Adolescents

Eligibility Criteria

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

You may qualify if:

  • 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

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, 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.

    PMID: 29282024DERIVED

MeSH Terms

Conditions

Self-Injurious Behavior

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

December 22, 2014

First Posted

December 25, 2014

Study Start

March 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 5, 2016

Record last verified: 2016-01

Locations

SE(1)