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

Nonsuicidal Self-Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02326012
• Other study ID #: 2014/1-31/3
• Status: Completed
• Phase: N/A
• First received: December 22, 2014
• Last updated: January 3, 2016
• Start date: March 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nonsuicidal Self-Injury

Intervention

Behavioral:
• 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	Euroqol-5D (EQ-5D)	Change from Baseline in quality of life after 14 weeks and at 6- and 12 months after treatment has Change from baseline in quality of life after 12 weeks and at 6 months after treatment has ended. Used for health economic evaluations.	Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up	No
Other	Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (TiC-P)	Change from Baseline in societal costs after 14 weeks and at 6- and 12 months after treatment has Change from baseline in quality of life after 12 weeks and at 6 months after treatment has ended. Used for health economic evaluations.	Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up	No
Other	Patient Health Questionnaire (PHQ9)	Change in patient parent health from baseline after 12 weeks and at 6 months after treatment has ended.	Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up	No
Other	General Anxiety Disorder (GAD7)	Change in patient parent health from baseline after 12 weeks and at 6 months after treatment has ended.	Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up	No
Other	The treatment credibility scale	Perceived treatment credibility	One week after treatment start	No
Other	Working Alliance Inventory (WAI) short version	Perceived working alliance	Three weeks after treatment start	No
Primary	Deliberate Self-Harm Inventory - 9 item version	Change from baseline in self-harming behaviors when measures weekly, after 12 weeks and at 6 months after treatment has ended.	Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up	Yes
Secondary	Borderline Symptom List Behavior supplement (BSL-supplement)	Change from baseline in self-destructive and risky behaviors when measures weekly, after 12 weeks and at 6 months after treatment has ended.	Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up	No
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 6 months after treatment has ended.	Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up	No
Secondary	Diary questionnaire (DQ)	Change from baseline in difficulties in emotion regulation when measures weekly, after 12 weeks and at 6 months after treatment has ended.	Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up	No
Secondary	Difficulties in Emotion Regulation Scale (DERS)	Change from baseline in difficulties in emotion regulation after 12 weeks and at 6 months after treatment has ended.	Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up	No
Secondary	Strengths and Difficulties Questionnaire Child and Parent version (SDQ-C/P)	Change from baseline in strengths and difficulties after 12 weeks and at 6 months after treatment has ended.	Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up	No
Secondary	Borderline personality features in childhood (BPFS-C)	Change from baseline in borderline personality features after 12 weeks and at 6 months after treatment has ended.	Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up	No
Secondary	The alcohol use disorders identification test - C (AUDIT-C)	Change from baseline in alcohol use after 12 weeks and at 6 months after treatment has ended.	Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up	No
Secondary	Evaluation of the Drug Use Disorders Identification Test - C (DUDIT-C)	Change from baseline in drug use after 12 weeks and at 6 months after treatment has ended.	Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up	No