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Internet Delivered ERITA for Nonsuicidal Self-Injury (ERITA)

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ClinicalTrials.gov Identifier: NCT03353961
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Clara Hellner Gumpert, Karolinska Institutet

Brief Summary:
To evaluate if Internet delivered emotion regulation individual therapy for adolescents is an efficacious treatment when delivered as adjunctive to treatment as usual compared to a control group consisting of treatment as usual.

Condition or disease Intervention/treatment Phase
Nonsuicidal Self-injury Behavioral: Emotion regulation individual therapy Behavioral: Treatment as usual Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Internet Delivered Emotion Regulation Individual Therapy for Adolescents With Nonsuicidal Self-Injury: A Randomized Controlled Study
Actual Study Start Date : November 20, 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Self-Harm

Arm Intervention/treatment
Experimental: Adjunctive Internet-delivered ERITA
Participants will receive 11 weeks of internet-delivered emotion regulation individual therapy with therapist support adjunctive to treatment as usual as provided in the community. The caregiver(s) will receive 6 modules of internet-delivered parent program with therapist support.
Behavioral: Emotion regulation individual therapy
The emotion regulation individual therapy is delivered via an internet platform and includes therapist contact several times per week via the platform.

Active Comparator: Treatment as usual
Participants will receive treatment as usual for 11 weeks of treatment as usual as provided in the community.
Behavioral: Treatment as usual
Treatment as usual as provided in the community.




Primary Outcome Measures :
  1. Deliberate Self-Harm Inventory Youth version (DSHI-Y) [ Time Frame: Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended ]
    Frequency of nonsuicidal self-injury


Secondary Outcome Measures :
  1. Difficulties in Emotion Regulation Scale - 16 item version (DERS-16) [ Time Frame: Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended ]
    Difficulties in emotion regulation as primary potential mechanism of change. Ranges from 16-80, with higher scores indicating more difficulties.

  2. Difficulties in Emotion Regulation Scale - 36 item version (DERS) [ Time Frame: Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended ]
    Difficulties in emotion regulation. Ranges from 36-180, with higher scores indicating more difficulties.

  3. the 21-item Depression Anxiety Stress Scales (DASS-21) [ Time Frame: Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended ]
    Symptoms of depression, anxiety and stress. Each subscale (depression, anxiety and stress) ranges from 0-21, with higher scores indicating more symptoms.

  4. Borderline Symptom List Supplement [ Time Frame: Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended ]
    Impulsive self-destructive behaviors

  5. Acceptance and Action Questionnaire [ Time Frame: Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended ]
    Acceptance and valued actions. Ranges from 7-49, with higher scores indicating less acceptance and valued actions.

  6. Childrens Global Assessment Scale [ Time Frame: Change from baseline, 16 weeks after treatment starts, 3 months after treatment has ended ]
    Global functioning. Ranges from 1-100, with higher scores indicating better functioning.

  7. The Clinical Global Impressions —Severity and Improvement scales [ Time Frame: Change from baseline, 16 weeks after treatment starts, 3 months after treatment has ended ]
    Global symptom severity and improvement. Severity of illness scale ranges from 1-7, with higher scores indicating higher severity of illness. Global improvement scale ranges from 1-7 with lower scores indicating more improvement.


Other Outcome Measures:
  1. Suicidal Ideation Questionnaire [ Time Frame: Pre-treatment ]
    Suicidal ideation. Past-month suicidal ideation ranges from 15-75, with higher scores indicating more suicidal ideation. This measure was only included for participant characterisation and safety (not intended to be analysed as outcome of change).

  2. Short version of the Experiences in Close Relationships Scale - Revised Child version [ Time Frame: Change from baseline, once every second week during treatment (0-12 weeks after baseline) ]
    Experiences in close relationships. Ranges from 12-84, with higher scores indicating greater problems.

  3. Generalised Anxiety Disorder 7-item scale [ Time Frame: Change from baseline, once every second week during treatment (0-12 weeks after baseline) ]
    Worry. Ranges 0-21, with higher scores indicating more worry.

  4. Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version [ Time Frame: Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended ]
    Costs associated with psychiatric illness

  5. Kidscreen-10 [ Time Frame: Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended ]
    Quality of life. Ranges 11-55, with higher scores indicating higher quality in life.

  6. Patient Internet-delivered cognitive behavioral Adherence Scale [ Time Frame: 6 and 12 weeks after baseline ]
    Patient adherence to treatment. Ranges from 0-20, with higher scores indicating higher adherence.

  7. Working Alliance Inventory [ Time Frame: 4 weeks after treatment starts ]
    Working alliance with online therapist

  8. The Coping with Children's Negative Emotions Scale Adolescent Version [ Time Frame: Change from baseline, 6 and 12 weeks after treatment starts, 3 and 12 months after treatment has ended ]
    Parents' perceived ability to cope with children's negative emotions. Three subscales will be used derived to reflect the specific types of coping response parents tend to use in these situations (punitive reactions, problem focused reactions, and minimization reactions). Each subscale ranges from 1-7.

  9. The Client Satisfaction Questionnaire [ Time Frame: 12 weeks after treatment starts ]
    Client satisfaction with treatment. Ranges from 8-32 with higher scores indicating greater treatment satisfaction.

  10. Adverse Events [ Time Frame: 12 weeks after treatment starts ]
    Self-rating scale that measures adverse events related to treatment

  11. Credibility/Expectancy Questionnaire [ Time Frame: 1 week after treatment starts ]
    Treatment credibility and expectancy. Ranges from 0-50 with higher scores indicating greater credibility/expectancy.



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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 5 nonsuicidal self-injury episodes past year
  • ≥ 1 nonsuicidal self-injury episodes past month
  • having at least one parent who committed to participate in the parent program

Exclusion Criteria:

  • Severe suicidal ideation
  • a diagnosis of psychotic or bipolar I disorder or ongoing (past month) substance dependence
  • the presence of co-occurring psychological disorders that required immediate treatment (i.e., severe anorexia nervosa)
  • insufficient understanding of the Swedish language

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353961


Contacts
Contact: Johan Bjureberg, MSc +46(0)700009188 Johan.Bjureberg@ki.se

Locations
Sweden
Centre for Psychiatry Research Karolinska Institutet and Stockholm County Council Recruiting
Stockholm, Sweden, 113 64
Contact: Johan Bjureberg, lic. Psychologist    +46(0)700009188    johan.bjureberg@ki.se   
Karolinska Institutet Recruiting
Stockholm, Sweden, 113 64
Principal Investigator: Clara Hellner Gumpert, PhD         
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Clara Hellner, PhD, MD Karolinska Institutet

Responsible Party: Clara Hellner Gumpert, PhD, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03353961     History of Changes
Other Study ID Numbers: 2017/10 BIP ERITA
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Clara Hellner Gumpert, Karolinska Institutet:
NSSI

Additional relevant MeSH terms:
Wounds and Injuries
Self-Injurious Behavior
Behavioral Symptoms