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

Primary Purpose

Nonsuicidal Self-Injury

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Internet-delivered Emotion Regulation Individual Therapy for Adolescents

About this trial

This is an interventional treatment trial for Nonsuicidal Self-Injury focused on measuring Nonsuicidal Self-Injury (NSSI), Deliberate Self-Harm (DSH), Self-harm, Self-injury

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Karolinska Institutet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Internet-delivered ERITA

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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

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

Suicidal Ideation Questionnaire (SIQ-JR)

Change from baseline in suicidal ideation after 12 weeks, at 3 and 6 months after treatment has ended

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

Full Information

NCT ID

NCT02697019

First Posted

February 26, 2016

Last Updated

August 9, 2018

Sponsor

Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT02697019

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

February 2016 (Actual)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nonsuicidal Self-Injury

Keywords

Nonsuicidal Self-Injury (NSSI), Deliberate Self-Harm (DSH), Self-harm, Self-injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Internet-delivered ERITA

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Internet-delivered Emotion Regulation Individual Therapy for Adolescents

Primary Outcome Measure Information:

Title

Deliberate Self-Harm Inventory - 9 item version

Description

Change from baseline in self-harming behaviors when measures weekly, after 12 weeks, and at 3 and 6 months after treatment has ended

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

Secondary Outcome Measure Information:

Title

Borderline Symptom List Behavior supplement (BSL-supplement)

Description

Change from baseline in self-destructive behaviors when measures weekly, after 12 weeks, and at 3 and 6 months after treatment has ended

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

Title

Difficulties in Emotion Regulation Scale -16 item version (DERS-16)

Description

Change from baseline in difficulties in emotion regulation when measures weekly, after 12 weeks, and at 3 and 6 months after treatment has ended

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

Title

Difficulties in Emotion Regulation Scale (DERS)

Description

Change from baseline in difficulties in emotion regulation after 12 weeks, at 3 and 6 months after treatment has ended

Time Frame

Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]

Title

Borderline personality features in childhood (BPFS-C)

Description

Change from baseline in symptoms of borderline personality disorder after 12 weeks, at 3 and 6 months after treatment has ended

Time Frame

Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]

Title

The Revised Child Anxiety and Depression Scale - Child and Parent rated (RCADS-C)

Description

Change from baseline in anxiety and depression after 12 weeks, at 3 and 6 months after treatment has ended

Time Frame

Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]

Title

Suicidal Ideation Questionnaire (SIQ-JR)

Description

Change from baseline in suicidal ideation after 12 weeks, at 3 and 6 months after treatment has ended

Time Frame

Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]

Title

Acceptance and Action Questionnaire (AAQ-7)

Description

Change from baseline in acceptance and action after 12 weeks, at 3 and 6 months after treatment has ended

Time Frame

Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]

Other Pre-specified Outcome Measures:

Title

The treatment credibility scale

Description

Perceived treatment credibility

Time Frame

One week after treatment start

Title

Working Alliance Inventory (WAI) short version

Description

Perceived working alliance

Time Frame

Three weeks after treatment start

Title

The Client Satisfaction Questionnaire (CSQ)

Description

Perceived client satisfaction

Time Frame

Twelve weeks after treatment start

Title

Adverse events

Description

Adverse events

Time Frame

12 weeks, and at 3 and 6 months after treatment has ended

Title

Adult ADHD Self-Report Scales (ASRS)

Description

Self-reported symptoms of attention-deficit/hyperactivity disorder (ADHD)

Time Frame

At baseline

Title

Parental Psychological Flexibility (PPF) Questionnaire

Description

Change from baseline in parental psychological flexibility after 12 weeks, at 3 and 6 months after treatment has ended

Time Frame

Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]

Title

The Coping with Children's Negative Emotions Scale Adolescent Version (CCNES-A)

Description

Change from baseline in parental coping after 12 weeks, at 3 and 6 months after treatment has ended

Time Frame

Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]

Title

The Parenting Sense of Competence (PSOC) Scale

Description

Change from baseline in parental coping after 12 weeks, at 3 and 6 months after treatment has ended

Time Frame

Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility 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)

Facility Information:

Facility Name

Karolinska Institutet

City

Stockholm

ZIP/Postal Code

113 64

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

30305103

Citation

Bjureberg J, Sahlin H, Hedman-Lagerlof E, Gratz KL, Tull MT, Jokinen J, Hellner C, Ljotsson B. Extending research on Emotion Regulation Individual Therapy for Adolescents (ERITA) with nonsuicidal self-injury disorder: open pilot trial and mediation analysis of a novel online version. BMC Psychiatry. 2018 Oct 11;18(1):326. doi: 10.1186/s12888-018-1885-6.

Results Reference

derived

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

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