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

August 9, 2018 updated by: Clara Hellner Gumpert, Karolinska Institutet
The primary aim is to investigate the effectiveness of an Internet-delivered Emotion Regulation Individual Therapy for Adolescents (ERITA) with nonsuicidal self-injury (NSSI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

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 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

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: Internet-delivered ERITA
Behavioral: Internet-delivered 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 (30 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks), and three and six months follow-up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Borderline Symptom List Behavior supplement (BSL-supplement)
Time Frame: 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
Change from baseline in self-destructive 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
Difficulties in Emotion Regulation Scale -16 item version (DERS-16)
Time Frame: 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
Change from baseline in difficulties in emotion regulation 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
Difficulties in Emotion Regulation Scale (DERS)
Time Frame: Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]
Change from baseline in difficulties in emotion regulation after 12 weeks, at 3 and 6 months after treatment has ended
Baseline (7 days prior to treatment start), post-treatment (12 weeks), three 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), three and six months follow-up]
Change from baseline in symptoms of borderline personality disorder after 12 weeks, at 3 and 6 months after treatment has ended
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)
Time Frame: Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]
Change from baseline in anxiety and depression after 12 weeks, at 3 and 6 months after treatment has ended
Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]
Suicidal Ideation Questionnaire (SIQ-JR)
Time Frame: Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]
Change from baseline in suicidal ideation after 12 weeks, at 3 and 6 months after treatment has ended
Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]
Acceptance and Action Questionnaire (AAQ-7)
Time Frame: Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]
Change from baseline in acceptance and action after 12 weeks, at 3 and 6 months after treatment has ended
Baseline (7 days prior to treatment start), post-treatment (12 weeks), three 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
The Client Satisfaction Questionnaire (CSQ)
Time Frame: Twelve weeks after treatment start
Perceived client satisfaction
Twelve weeks after treatment start
Adverse events
Time Frame: 12 weeks, and at 3 and 6 months after treatment has ended
Adverse events
12 weeks, and at 3 and 6 months after treatment has ended
Adult ADHD Self-Report Scales (ASRS)
Time Frame: At baseline
Self-reported symptoms of attention-deficit/hyperactivity disorder (ADHD)
At baseline
Parental Psychological Flexibility (PPF) Questionnaire
Time Frame: Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]
Change from baseline in parental psychological flexibility after 12 weeks, at 3 and 6 months after treatment has ended
Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]
The Coping with Children's Negative Emotions Scale Adolescent Version (CCNES-A)
Time Frame: Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]
Change from baseline in parental coping after 12 weeks, at 3 and 6 months after treatment has ended
Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]
The Parenting Sense of Competence (PSOC) Scale
Time Frame: Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]
Change from baseline in parental coping after 12 weeks, at 3 and 6 months after treatment has ended
Baseline (7 days prior to treatment start), post-treatment (12 weeks), three 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 (Actual)

February 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

February 26, 2016

First Submitted That Met QC Criteria

February 26, 2016

First Posted (Estimate)

March 2, 2016

Study Record Updates

Last Update Posted (Actual)

August 10, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/1895-31/5

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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