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Completed

NCT Number: NCT02697019

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

The primary aim is to investigate the effectiveness of an Internet-delivered Emotion Regulation Individual Therapy for Adolescents (ERITA) with nonsuicidal self-injury (NSSI).

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Key information

Conditions

Nonsuicidal Self-Injury Behavior Behavioral Symptoms Dyschromatosis symmetrica hereditaria 1 Self-Injurious Behavior

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, 113 64, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Internet-delivered Emotion Regulation Individual Therapy for Adolescents

Behavioral

Primary outcomes

  1. Deliberate Self-Harm Inventory - 9 item version

    Time frame: 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

    Change from baseline in self-harming behaviors when measures weekly, after 12 weeks, and at 3 and 6 months after treatment has ended

Secondary outcomes

  1. Borderline Symptom List Behavior supplement (BSL-supplement)

    Time frame: 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

    Change from baseline in self-destructive behaviors when measures weekly, after 12 weeks, and at 3 and 6 months after treatment has ended

  2. Difficulties in Emotion Regulation Scale -16 item version (DERS-16)

    Time frame: 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

    Change from baseline in difficulties in emotion regulation when measures weekly, after 12 weeks, and at 3 and 6 months after treatment has ended

  3. Difficulties in Emotion Regulation Scale (DERS)

    Time frame: Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]

    Change from baseline in difficulties in emotion regulation after 12 weeks, at 3 and 6 months after treatment has ended

  4. Borderline personality features in childhood (BPFS-C)

    Time frame: Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]

    Change from baseline in symptoms of borderline personality disorder after 12 weeks, at 3 and 6 months after treatment has ended

  5. The Revised Child Anxiety and Depression Scale - Child and Parent rated (RCADS-C)

    Time frame: Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]

    Change from baseline in anxiety and depression after 12 weeks, at 3 and 6 months after treatment has ended

  6. Suicidal Ideation Questionnaire (SIQ-JR)

    Time frame: Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]

    Change from baseline in suicidal ideation after 12 weeks, at 3 and 6 months after treatment has ended

  7. Acceptance and Action Questionnaire (AAQ-7)

    Time frame: Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]

    Change from baseline in acceptance and action after 12 weeks, at 3 and 6 months after treatment has ended

Other outcomes

  1. The treatment credibility scale

    Time frame: One week after treatment start

    Perceived treatment credibility

  2. Working Alliance Inventory (WAI) short version

    Time frame: Three weeks after treatment start

    Perceived working alliance

  3. The Client Satisfaction Questionnaire (CSQ)

    Time frame: Twelve weeks after treatment start

    Perceived client satisfaction

  4. Adverse events

    Time frame: 12 weeks, and at 3 and 6 months after treatment has ended

    Adverse events

  5. Adult ADHD Self-Report Scales (ASRS)

    Time frame: At baseline

    Self-reported symptoms of attention-deficit/hyperactivity disorder (ADHD)

  6. Parental Psychological Flexibility (PPF) Questionnaire

    Time frame: Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]

    Change from baseline in parental psychological flexibility after 12 weeks, at 3 and 6 months after treatment has ended

  7. The Coping with Children's Negative Emotions Scale Adolescent Version (CCNES-A)

    Time frame: Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]

    Change from baseline in parental coping after 12 weeks, at 3 and 6 months after treatment has ended

  8. The Parenting Sense of Competence (PSOC) Scale

    Time frame: Baseline (7 days prior to treatment start), post-treatment (12 weeks), three and six months follow-up]

    Change from baseline in parental coping after 12 weeks, at 3 and 6 months after treatment has ended

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 2, 2016
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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