Clinical trial NCT02326012: 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
Overall status: COMPLETED
Phase: NA
Conditions: Nonsuicidal Self-Injury
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2014-12-25
Enrollment: 17
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: Deliberate Self-Harm Inventory - 9 item version
timeFrame: Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up
Secondary outcomes:
measure: Borderline Symptom List Behavior supplement (BSL-supplement)
timeFrame: Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up
measure: Difficulties in Emotion Regulation Scale -16 item version (DERS-16)
timeFrame: Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up
measure: Diary questionnaire (DQ)
timeFrame: Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
measure: Strengths and Difficulties Questionnaire Child and Parent version (SDQ-C/P)
timeFrame: Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
measure: Borderline personality features in childhood (BPFS-C)
timeFrame: Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
measure: The alcohol use disorders identification test - C (AUDIT-C)
timeFrame: Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
measure: Evaluation of the Drug Use Disorders Identification Test - C (DUDIT-C)
timeFrame: Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
Other outcomes:
measure: Euroqol-5D (EQ-5D)
timeFrame: Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
measure: Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (TiC-P)
timeFrame: Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
measure: Patient Health Questionnaire (PHQ9)
timeFrame: Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
measure: General Anxiety Disorder (GAD7)
timeFrame: Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up
measure: The treatment credibility scale
timeFrame: One week after treatment start
measure: Working Alliance Inventory (WAI) short version
timeFrame: Three weeks after treatment start
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
References:
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.