Emotion Regulation Individual Therapy for Adolescents With NSSI - An Open Pilot Study

January 3, 2016 updated by: Clara Hellner Gumpert, Karolinska Institutet
The primary aim is to investigate the effectiveness of Emotion Regulation Individual Therapy for Adolescents (ERITA) who self-harm.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 113 64
        • Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Emotion Regulation Individual Therapy for Adolescents
Behavioral: Emotion Regulation Individual Therapy for Adolescents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline in self-destructive and risky 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
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
Change from baseline in difficulties in emotion regulation 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
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
Change from baseline in difficulties in emotion regulation 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
Difficulties in Emotion Regulation Scale (DERS)
Time Frame: Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
Change from baseline in difficulties in emotion regulation after 12 weeks and at 6 months after treatment has ended.
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
Change from baseline in strengths and difficulties after 12 weeks and at 6 months after treatment has ended.
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
Change from baseline in borderline personality features after 12 weeks and at 6 months after treatment has ended.
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
Change from baseline in alcohol use after 12 weeks and at 6 months after treatment has ended.
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
Change from baseline in drug use after 12 weeks and at 6 months after treatment has ended.
Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The treatment credibility scale
Time Frame: One week after treatment start
Perceived treatment credibility
One week after treatment start
Working Alliance Inventory (WAI) short version
Time Frame: Three weeks after treatment start
Perceived working alliance
Three weeks after treatment start
Euroqol-5D (EQ-5D)
Time Frame: Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
Change from Baseline in quality of life after 14 weeks and at 6- and 12 months after treatment has Change from baseline in quality of life after 12 weeks and at 6 months after treatment has ended. Used for health economic evaluations.
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)
Time Frame: Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
Change from Baseline in societal costs after 14 weeks and at 6- and 12 months after treatment has Change from baseline in quality of life after 12 weeks and at 6 months after treatment has ended. Used for health economic evaluations.
Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
Patient Health Questionnaire (PHQ9)
Time Frame: Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
Change in patient parent health from baseline after 12 weeks and at 6 months after treatment has ended.
Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
General Anxiety Disorder (GAD7)
Time Frame: Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
Change in patient parent health from baseline after 12 weeks and at 6 months after treatment has ended.
Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

December 22, 2014

First Submitted That Met QC Criteria

December 22, 2014

First Posted (Estimate)

December 25, 2014

Study Record Updates

Last Update Posted (Estimate)

January 5, 2016

Last Update Submitted That Met QC Criteria

January 3, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/1-31/3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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