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

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

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

Conditions
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Nonsuicidal Self-Injury

Intervention / Treatment
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* Behavioral: Internet-delivered Emotion Regulation Individual Therapy for Adolescents


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-delivered ERITA<br> | Behavioral: Internet-delivered Emotion Regulation Individual Therapy for Adolescents<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Borderline Symptom List Behavior supplement (BSL-supplement) | 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) | 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) | 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) | 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) | 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) | 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) | 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] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nonsuicidal Self-Injury (NSSI), Deliberate Self-Harm (DSH), Self-harm, Self-injury