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

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ClinicalTrials.gov Identifier: NCT02697019
Recruitment Status : Completed
First Posted : March 2, 2016
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Clara Hellner Gumpert, Karolinska Institutet

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).

Condition or disease Intervention/treatment Phase
Nonsuicidal Self-Injury Behavioral: Internet-delivered Emotion Regulation Individual Therapy for Adolescents Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet-delivered Emotion Regulation Individual Therapy for Adolescents With NSSI - An Open Pilot Study
Actual Study Start Date : February 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Self-Harm

Arm Intervention/treatment
Experimental: Internet-delivered ERITA Behavioral: Internet-delivered Emotion Regulation Individual Therapy for Adolescents



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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


Other Outcome Measures:
  1. The treatment credibility scale [ Time Frame: One week after treatment start ]
    Perceived treatment credibility

  2. Working Alliance Inventory (WAI) short version [ Time Frame: Three weeks after treatment start ]
    Perceived working alliance

  3. The Client Satisfaction Questionnaire (CSQ) [ Time Frame: Twelve weeks after treatment start ]
    Perceived client satisfaction

  4. Adverse events [ Time Frame: 12 weeks, and at 3 and 6 months after treatment has ended ]
    Adverse events

  5. Adult ADHD Self-Report Scales (ASRS) [ Time Frame: At baseline ]
    Self-reported symptoms of attention-deficit/hyperactivity disorder (ADHD)

  6. 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

  7. 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

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02697019


Locations
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Sweden
Karolinska Institutet
Stockholm, Sweden, 113 64
Sponsors and Collaborators
Karolinska Institutet

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Clara Hellner Gumpert, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02697019     History of Changes
Other Study ID Numbers: 2015/1895-31/5
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018

Keywords provided by Clara Hellner Gumpert, Karolinska Institutet:
Nonsuicidal Self-Injury (NSSI), Deliberate Self-Harm (DSH), Self-harm, Self-injury

Additional relevant MeSH terms:
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Self-Injurious Behavior
Behavioral Symptoms