Clinical trial NCT02697019: Internet-delivered Emotion Regulation Individual Therapy for Adolescents With NSSI - An Open Pilot Study
Official title: Internet-delivered Emotion Regulation Individual Therapy for Adolescents With NSSI - An Open Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonsuicidal Self-Injury
Keywords: Nonsuicidal Self-Injury (NSSI), Deliberate Self-Harm (DSH), Self-harm, Self-injury
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2016-03-02
Enrollment: 25
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 an Internet-delivered Emotion Regulation Individual Therapy for Adolescents (ERITA) with nonsuicidal self-injury (NSSI).


Eligibility criteria: 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)

Primary outcomes:
measure: Deliberate Self-Harm Inventory - 9 item version
timeFrame: 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 outcomes:
measure: Borderline Symptom List Behavior supplement (BSL-supplement)
timeFrame: 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
measure: Difficulties in Emotion Regulation Scale -16 item version (DERS-16)
timeFrame: 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
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Baseline (7 days prior to treatment start), post-treatment (12 weeks), three 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), three and six months follow-up]
measure: The Revised Child Anxiety and Depression Scale - Child and Parent rated (RCADS-C)
timeFrame: Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]
measure: Suicidal Ideation Questionnaire (SIQ-JR)
timeFrame: Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]
measure: Acceptance and Action Questionnaire (AAQ-7)
timeFrame: Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]
Other outcomes:
measure: The treatment credibility scale
timeFrame: One week after treatment start
measure: Working Alliance Inventory (WAI) short version
timeFrame: Three weeks after treatment start
measure: The Client Satisfaction Questionnaire (CSQ)
timeFrame: Twelve weeks after treatment start
measure: Adverse events
timeFrame: 12 weeks, and at 3 and 6 months after treatment has ended
measure: Adult ADHD Self-Report Scales (ASRS)
timeFrame: At baseline
measure: Parental Psychological Flexibility (PPF) Questionnaire
timeFrame: Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]
measure: The Coping with Children's Negative Emotions Scale Adolescent Version (CCNES-A)
timeFrame: Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]
measure: The Parenting Sense of Competence (PSOC) Scale
timeFrame: Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
References:
citation: Bjureberg J, Sahlin H, Hedman-Lagerlof E, Gratz KL, Tull MT, Jokinen J, Hellner C, Ljotsson B. Extending research on Emotion Regulation Individual Therapy for Adolescents (ERITA) with nonsuicidal self-injury disorder: open pilot trial and mediation analysis of a novel online version. BMC Psychiatry. 2018 Oct 11;18(1):326. doi: 10.1186/s12888-018-1885-6.