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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
Emotion Regulation Individual Therapy for Adolescents
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonsuicidal Self-Injury

Eligibility Criteria

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

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)

Sites / Locations

  • Karolinska Institutet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Emotion Regulation Individual Therapy for Adolescents

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 6 months after treatment has ended.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
December 22, 2014
Last Updated
January 3, 2016
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT02326012
Brief Title
Emotion Regulation Individual Therapy for Adolescents With NSSI - An Open Pilot Study
Official Title
Emotion Regulation Individual Therapy for Adolescents With NSSI - An Open Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonsuicidal 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
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Emotion Regulation Individual Therapy for Adolescents
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
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 6 months after treatment has ended.
Time Frame
Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up
Secondary Outcome Measure Information:
Title
Borderline Symptom List Behavior supplement (BSL-supplement)
Description
Change from baseline in self-destructive and risky behaviors when measures weekly, after 12 weeks and at 6 months after treatment has ended.
Time Frame
Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) 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 6 months after treatment has ended.
Time Frame
Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up
Title
Diary questionnaire (DQ)
Description
Change from baseline in difficulties in emotion regulation when measures weekly, after 12 weeks and at 6 months after treatment has ended.
Time Frame
Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up
Title
Difficulties in Emotion Regulation Scale (DERS)
Description
Change from baseline in difficulties in emotion regulation after 12 weeks and at 6 months after treatment has ended.
Time Frame
Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
Title
Strengths and Difficulties Questionnaire Child and Parent version (SDQ-C/P)
Description
Change from baseline in strengths and difficulties after 12 weeks and at 6 months after treatment has ended.
Time Frame
Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
Title
Borderline personality features in childhood (BPFS-C)
Description
Change from baseline in borderline personality features after 12 weeks and at 6 months after treatment has ended.
Time Frame
Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
Title
The alcohol use disorders identification test - C (AUDIT-C)
Description
Change from baseline in alcohol use after 12 weeks and at 6 months after treatment has ended.
Time Frame
Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
Title
Evaluation of the Drug Use Disorders Identification Test - C (DUDIT-C)
Description
Change from baseline in drug use after 12 weeks and at 6 months after treatment has ended.
Time Frame
Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
Other Pre-specified Outcome Measures:
Title
Euroqol-5D (EQ-5D)
Description
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.
Time Frame
Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
Title
Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (TiC-P)
Description
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.
Time Frame
Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
Title
Patient Health Questionnaire (PHQ9)
Description
Change in patient parent health from baseline after 12 weeks and at 6 months after treatment has ended.
Time Frame
Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
Title
General Anxiety Disorder (GAD7)
Description
Change in patient parent health from baseline after 12 weeks and at 6 months after treatment has ended.
Time Frame
Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
113 64
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
29282024
Citation
Bjureberg J, Sahlin H, Hellner C, Hedman-Lagerlof E, Gratz KL, Bjarehed J, Jokinen J, Tull MT, Ljotsson B. Emotion regulation individual therapy for adolescents with nonsuicidal self-injury disorder: a feasibility study. BMC Psychiatry. 2017 Dec 28;17(1):411. doi: 10.1186/s12888-017-1527-4.
Results Reference
derived

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

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