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Completed

NCT Number: NCT02326012

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

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

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Key information

Conditions

Nonsuicidal Self-Injury Behavior Behavioral Symptoms 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 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)

Treatment and study plan

Emotion Regulation Individual Therapy for Adolescents

Behavioral

Primary outcomes

  1. Deliberate Self-Harm Inventory - 9 item version

    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

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

Secondary outcomes

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

    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

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

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

    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

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

  3. Diary questionnaire (DQ)

    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

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

  4. Difficulties in Emotion Regulation Scale (DERS)

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

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

  5. Strengths and Difficulties Questionnaire Child and Parent version (SDQ-C/P)

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

    Change from baseline in strengths and difficulties after 12 weeks and at 6 months after treatment has ended.

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

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

    Change from baseline in borderline personality features after 12 weeks and at 6 months after treatment has ended.

  7. The alcohol use disorders identification test - C (AUDIT-C)

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

    Change from baseline in alcohol use after 12 weeks and at 6 months after treatment has ended.

  8. Evaluation of the Drug Use Disorders Identification Test - C (DUDIT-C)

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

    Change from baseline in drug use after 12 weeks and at 6 months after treatment has ended.

Other outcomes

  1. Euroqol-5D (EQ-5D)

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

    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.

  2. Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (TiC-P)

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

    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.

  3. Patient Health Questionnaire (PHQ9)

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

    Change in patient parent health from baseline after 12 weeks and at 6 months after treatment has ended.

  4. General Anxiety Disorder (GAD7)

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

    Change in patient parent health from baseline after 12 weeks and at 6 months after treatment has ended.

  5. The treatment credibility scale

    Time frame: One week after treatment start

    Perceived treatment credibility

  6. Working Alliance Inventory (WAI) short version

    Time frame: Three weeks after treatment start

    Perceived working alliance

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 25, 2014
Registry last updated
Jan 5, 2016

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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