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

Nonsuicidal Self-Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02697019
• Other study ID #: 2015/1895-31/5
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: December 2017

Study information

• Verified date: August 2018
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Nonsuicidal Self-Injury
• Self-Injurious Behavior

Intervention

Behavioral:
• Internet-delivered Emotion Regulation Individual Therapy for Adolescents

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The treatment credibility scale	Perceived treatment credibility	One week after treatment start
Other	Working Alliance Inventory (WAI) short version	Perceived working alliance	Three weeks after treatment start
Other	The Client Satisfaction Questionnaire (CSQ)	Perceived client satisfaction	Twelve weeks after treatment start
Other	Adverse events	Adverse events	12 weeks, and at 3 and 6 months after treatment has ended
Other	Adult ADHD Self-Report Scales (ASRS)	Self-reported symptoms of attention-deficit/hyperactivity disorder (ADHD)	At baseline
Other	Parental Psychological Flexibility (PPF) Questionnaire	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]
Other	The Coping with Children's Negative Emotions Scale Adolescent Version (CCNES-A)	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]
Other	The Parenting Sense of Competence (PSOC) Scale	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]
Primary	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	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
Secondary	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
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]