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

Not Applicable

Completed

• Conditions: Nonsuicidal Self-Injury

• Registration Number: NCT02326012
• Lead Sponsor: Karolinska Institutet

Brief Summary

The primary aim is to investigate the effectiveness of Emotion Regulation Individual Therapy for Adolescents (ERITA) who self-harm.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-12-22
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-25
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-03
• Last Update Posted: 2016-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• a primary diagnosis of NSSI as defined by DSM-5 Section 3
• < 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Deliberate Self-Harm Inventory - 9 item version	Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up	Change from baseline in self-harming behaviors when measures weekly, after 12 weeks and at 6 months after treatment has ended.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the Drug Use Disorders Identification Test - C (DUDIT-C)	Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up	Change from baseline in drug use after 12 weeks and at 6 months after treatment has ended.
Borderline Symptom List Behavior supplement (BSL-supplement)	Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up	Change from baseline in self-destructive and risky behaviors when measures weekly, after 12 weeks and at 6 months after treatment has ended.
Difficulties in Emotion Regulation Scale -16 item version (DERS-16)	Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up	Change from baseline in difficulties in emotion regulation when measures weekly, after 12 weeks and at 6 months after treatment has ended.
Diary questionnaire (DQ)	Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up	Change from baseline in difficulties in emotion regulation when measures weekly, after 12 weeks and at 6 months after treatment has ended.
Difficulties in Emotion Regulation Scale (DERS)	Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up	Change from baseline in difficulties in emotion regulation after 12 weeks and at 6 months after treatment has ended.
Strengths and Difficulties Questionnaire Child and Parent version (SDQ-C/P)	Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up	Change from baseline in strengths and difficulties after 12 weeks and at 6 months after treatment has ended.
Borderline personality features in childhood (BPFS-C)	Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up	Change from baseline in borderline personality features after 12 weeks and at 6 months after treatment has ended.
The alcohol use disorders identification test - C (AUDIT-C)	Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up	Change from baseline in alcohol use after 12 weeks and at 6 months after treatment has ended.

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden