Internet Delivered ERITA for Nonsuicidal Self-Injury

Study Overview
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Brief Summary
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To evaluate if Internet delivered emotion regulation individual therapy for adolescents is an efficacious treatment when delivered as adjunctive to treatment as usual compared to a control group consisting of treatment as usual.

Detailed Description
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Statistical Analyses Treatment effects will be evaluated according to the intention-to-treat principle. Primary end-point for all outcomes is post-treatment. Secondary end-point include a controlled 3 month follow-up. Primary Analysis The primary outcome analysis will include treatment group (ERITA , TAU) and weekly reports of NSSI frequency measured once every week 4 weeks prior to treatment start, once every week during treatment, and once every week four weeks after treatment termination. Regression analysis modelled for count data will be used to estimate trend over time. Four weeks after treatment termination will be considered primary endpoint. Pairwise contrasts (group x time interaction) from the regression model will be used to evaluate between-group differences at primary endpoint (4 weeks after treatment termination). Secondary Analyses Secondary outcomes measured once before, during, and after treatment will be analyzed in a similar fashion as for the primary outcome, modelled after data's distribution (count or continuous). Measures collected only once at baseline and post-treatment will be analyzed with regression analyses including treatment group (online ERITA , TAU) as the between-subjects factor, time (baseline to post) as the within-subjects factor, and group × time interactions, modelled after data's distribution (count or continuous). Parallel process latent growth curve modeling will be used to determine whether change in week-to-week emotion dysregulation (DERS-16) during treatment mediate the overall effect of ERITA+ETAU on week-to-week change in the primary outcome self-rated NSSI frequency (DSHI-Y). 3 Month Follow-Up Data collected at 3-month follow-up will be used to determine the extent to which potential treatment gains were maintained both within and between treatment conditions Update 28 April 2022: As a secondary analyses, we also aim to investigate the effect of treatment moderators (primary aim) and predictors (secondary aim) on NSSI frequency one month after treatment termination. This update was submitted prior to conducting the analyses. The selection of potential moderators was theoretically and empirically motivated. We will investigate the following variables (measured at baseline): Age Difficulties in emotion regulation As measured with the Difficulties in Emotion Regulation Scale - 36 item version (DERS) Past month NSSI frequency As measured with the Deliberate Self-Harm Inventory Youth version (DSHI-Y) Global functioning As measured with the Childrens Global Assessment Scale Depressive symptoms As measured with the 21-item Depression Anxiety Stress Scales (DASS-21) Sleep difficulties As measured with the Insomnia Severity Index (ISI) Parental Minimization - discounting or devaluing the child's negative emotions/problems As measured with The Coping with Children's Negative Emotions Scale Adolescent Version (CCNES-A), subscale minimazation Level of suicidality As measured with the MINI-KID International Neuropsychiatric Interview, version 6

Official Title
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Internet Delivered Emotion Regulation Individual Therapy for Adolescents With Nonsuicidal Self-Injury: A Randomized Controlled Study

Conditions
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Nonsuicidal Self-injury

Intervention / Treatment
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* Behavioral: Emotion regulation individual therapy
* Behavioral: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 5 nonsuicidal self-injury episodes past year ≥ 1 nonsuicidal self-injury episodes past month having at least one parent who committed to participate in the parent program Exclusion Criteria: Severe suicidal ideation a diagnosis of psychotic or bipolar I disorder or ongoing (past month) substance dependence the presence of co-occurring psychological disorders that required immediate treatment (i.e., severe anorexia nervosa) insufficient understanding of the Swedish language

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adjunctive Internet-delivered ERITA<br>Participants will receive 11 weeks of internet-delivered emotion regulation individual therapy with therapist support adjunctive to treatment as usual as provided in the community. The caregiver(s) will receive 6 modules of internet-delivered parent program with therapist support. | Behavioral: Emotion regulation individual therapy<br>* The emotion regulation individual therapy is delivered via an internet platform and includes therapist contact several times per week via the platform.<br>|
| Active Comparator: Treatment as usual<br>Participants will receive treatment as usual for 11 weeks of treatment as usual as provided in the community. | Behavioral: Treatment as usual<br>* Treatment as usual as provided in the community.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deliberate Self-Harm Inventory Youth version (DSHI-Y) | Frequency of nonsuicidal self-injury | Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difficulties in Emotion Regulation Scale - 16 item version (DERS-16) | Difficulties in emotion regulation as primary potential mechanism of change. Ranges from 16-80, with higher scores indicating more difficulties. | Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended | 
| Difficulties in Emotion Regulation Scale - 36 item version (DERS) | Difficulties in emotion regulation. Ranges from 36-180, with higher scores indicating more difficulties. | Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended | 
| the 21-item Depression Anxiety Stress Scales (DASS-21) | Symptoms of depression, anxiety and stress. Each subscale (depression, anxiety and stress) ranges from 0-21, with higher scores indicating more symptoms. | Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended | 
| Borderline Symptom List Supplement | Impulsive self-destructive behaviors | Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended | 
| Acceptance and Action Questionnaire | Acceptance and valued actions. Ranges from 7-49, with higher scores indicating less acceptance and valued actions. | Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended | 
| Childrens Global Assessment Scale | Global functioning. Ranges from 1-100, with higher scores indicating better functioning. | Change from baseline, 16 weeks after treatment starts, 3 months after treatment has ended | 
| The Clinical Global Impressions -Severity and Improvement scales | Global symptom severity and improvement. Severity of illness scale ranges from 1-7, with higher scores indicating higher severity of illness. Global improvement scale ranges from 1-7 with lower scores indicating more improvement. | Change from baseline, 16 weeks after treatment starts, 3 months after treatment has ended | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSSI