Internet-delivered Emotion Regulation Individual Therapy or Adolescents (IERITA) With Self-injury Within Child and Adolescent Mental Health Services: Pilot Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Adaptable IERITA: IERITA is a 12-week acceptance-based behavioral therapy. The goal is to reduce self-injury through learning and using other ways to regulate emotions. IERITA includes modules where the participants can read text, watch videos, listen to audio, and message their allocated therapists. The adolescent treatment is 11 modules, and the parent course is six. Both adolescents and parents receive separate asynchronous online therapist support. The adapted IERITA intervention is tailored to the participant and can thus entail different adaptions for different participants. Adaptions can entail changes in therapist contact, what material to focus on, and how to work with the treatment. The adapted IERITA intervention is offered between week four and 12.

Standard IERITA: IERITA is a 12-week acceptance-based behavioral therapy. The goal is to reduce self-injury through learning and using other ways to regulate emotions. IERITA includes modules where the participants can read text, watch videos, listen to audio, and message their allocated therapists. The adolescent treatment is 11 modules, and the parent course is six. Both adolescents and parents receive separate asynchronous online therapist support.

Treatment as usual: Participants are free to any receive regular care (i.e., psychosocial treatment, medications, or a combination of both) as needed during the trial.

Study summary

The overall purpose of the study is to implement and evaluate IERITA (Internet-delivered Emotion Regulation Individual Therapy for Adolescents) within child and adolescent mental health services for adolescents engaging in nonsuicidal self-injury (NSSI) and to optimize treatment outcomes for those adolescents at risk of insufficient effects. The specific purpose of this pilot trial is to investigate feasibility in preparation for a larger trial.

Eligibility

Primary outcome measure(s)

• Deliberate Self-harm Inventory - Youth version (DSHI-Y) — One-, three- and twelve-months post-treatment
  The DSHI-Y measures the frequency of the most common NSSI behaviors. The primary outcome will be the proportion of treatment remission. Remission will be defined as the absence of self-injury the past 30 days. Clinician-rated.
• Internet Intervention Patient Adherence Scale (iiPAS) — Treatment week 3 and post-treatment (week 12)
  The IIPAS measures patient adherence to guided internet-delivered behavioral interventions. This scale has 5 items, and a total score ranging from 0 to 20, where 0 indicates no adherence and 20 perfect adherence. Clinician-rated.
• Credibility/Expectancy Questionnaire (CEQ) - 1 item version — Treatment week 3
  CEQ measures treatment credibility and expectancy. This version of the scale has 1 item ranging from 0 to 100, with higher scores indicating greater credibility/expectancy. Self-rated (adolescent).
• The Client Satisfaction Questionnaire (CSQ) — Post-treatment (week 12)
  The CSQ measures satisfaction with treatment. This scale has 8 items and a summary score ranging from 8 to 32, with higher scores indicating greater treatment satisfaction. Self-rated (adolescent and parent).
• Therapist time — Post-treatment (week 12)
  Clinicians report time spent on treatment.
• Number of completed sessions and modules — Post-treatment (week 12)
  Clinicians report number of completed sessions and modules for adolescents and parents.
• Rate of treatment adaptions — Post-treatment (week 12)
  Clinicians report presence or absence of possible treatment adaptions (e.g., changes in therapist contact or what material to focus on).
• Degree of partcipation in data collection — One-month post-treatment
  The proportion of adolescents completing the primary clinical outcome, Deliberate Self-harm Inventory - Youth version, either through interview or self-report questionnaire at one-month post-treatment
• Adapted ICBT Therapist Rating Scale (ICBT-TRS) — Through study completion, an average of 1 year
  Therapist behaviors are rated separately as 0 (absence of behavior), 1 (inadequate performance), or 2 (competent). Rated by experienced clinical supervisors.

Trial sites (1)

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