Internet Delivered ERITA for Nonsuicidal Self-Injury

Nonsuicidal Self-injury Clinical Trial

— ERITA  

Official title:

Internet Delivered Emotion Regulation Individual Therapy for Adolescents With Nonsuicidal Self-Injury: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03353961
• Other study ID #: 2017/10 BIP ERITA
• Status: Completed
• Phase: N/A
• Start date: November 20, 2017
• Est. completion date: October 17, 2021

Study information

• Verified date: April 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Statistical Analyses

Treatment effects will be evaluated according to the intention-to-treat principle. Primary end-point for all outcomes is post-treatment. Secondary end-point include a controlled 3 month follow-up.

Primary Analysis

The primary outcome analysis will include treatment group (ERITA , TAU) and weekly reports of NSSI frequency measured once every week 4 weeks prior to treatment start, once every week during treatment, and once every week four weeks after treatment termination. Regression analysis modelled for count data will be used to estimate trend over time. Four weeks after treatment termination will be considered primary endpoint. Pairwise contrasts (group x time interaction) from the regression model will be used to evaluate between-group differences at primary endpoint (4 weeks after treatment termination).

Secondary Analyses

Secondary outcomes measured once before, during, and after treatment will be analyzed in a similar fashion as for the primary outcome, modelled after data's distribution (count or continuous). Measures collected only once at baseline and post-treatment will be analyzed with regression analyses including treatment group (online ERITA , TAU) as the between-subjects factor, time (baseline to post) as the within-subjects factor, and group × time interactions, modelled after data's distribution (count or continuous).

Parallel process latent growth curve modeling will be used to determine whether change in week-to-week emotion dysregulation (DERS-16) during treatment mediate the overall effect of ERITA+ETAU on week-to-week change in the primary outcome self-rated NSSI frequency (DSHI-Y).

3 Month Follow-Up

Data collected at 3-month follow-up will be used to determine the extent to which potential treatment gains were maintained both within and between treatment conditions

Update 28 April 2022: As a secondary analyses, we also aim to investigate the effect of treatment moderators (primary aim) and predictors (secondary aim) on NSSI frequency one month after treatment termination. This update was submitted prior to conducting the analyses.

The selection of potential moderators was theoretically and empirically motivated. We will investigate the following variables (measured at baseline):

Age Difficulties in emotion regulation As measured with the Difficulties in Emotion Regulation Scale - 36 item version (DERS) Past month NSSI frequency As measured with the Deliberate Self-Harm Inventory Youth version (DSHI-Y) Global functioning As measured with the Childrens Global Assessment Scale Depressive symptoms As measured with the 21-item Depression Anxiety Stress Scales (DASS-21) Sleep difficulties As measured with the Insomnia Severity Index (ISI) Parental Minimization - discounting or devaluing the child's negative emotions/problems As measured with The Coping with Children's Negative Emotions Scale Adolescent Version (CCNES-A), subscale minimazation Level of suicidality As measured with the MINI-KID International Neuropsychiatric Interview, version 6

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: October 17, 2021
• Est. primary completion date: January 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Nonsuicidal Self-injury
• Self-Injurious Behavior
• Wounds and Injuries

Intervention

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.
• Treatment as usual
Treatment as usual as provided in the community.

Locations

Country	Name	City	State
Sweden	Centre for Psychiatry Research Karolinska Institutet and Stockholm County Council	Stockholm
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Short version of the Experiences in Close Relationships Scale - Revised Child version	Experiences in close relationships. Ranges from 12-84, with higher scores indicating greater problems.	Change from baseline, once every second week during treatment (0-12 weeks after baseline)
Other	Generalised Anxiety Disorder 7-item scale	Worry. Ranges 0-21, with higher scores indicating more worry.	Change from baseline, once every second week during treatment (0-12 weeks after baseline)
Other	Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version	Costs associated with psychiatric illness	Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Other	Kidscreen-10	Quality of life. Ranges 11-55, with higher scores indicating higher quality in life.	Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Other	Patient Internet-delivered cognitive behavioral Adherence Scale	Patient adherence to treatment. Ranges from 0-20, with higher scores indicating higher adherence.	6 and 12 weeks after baseline
Other	Working Alliance Inventory	Working alliance with online therapist	4 weeks after treatment starts
Other	The Coping with Children's Negative Emotions Scale Adolescent Version	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.	Change from baseline, 6 and 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Other	The Client Satisfaction Questionnaire	Client satisfaction with treatment. Ranges from 8-32 with higher scores indicating greater treatment satisfaction.	12 weeks after treatment starts
Other	Adverse Events	Self-rating scale that measures adverse events related to treatment	12 weeks after treatment starts
Other	Credibility/Expectancy Questionnaire	Treatment credibility and expectancy. Ranges from 0-50 with higher scores indicating greater credibility/expectancy.	1 week after treatment starts
Primary	Deliberate Self-Harm Inventory Youth version (DSHI-Y)	Frequency of nonsuicidal self-injury	Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended
Secondary	Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)	Difficulties in emotion regulation as primary potential mechanism of change. Ranges from 16-80, with higher scores indicating more difficulties.	Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended
Secondary	Difficulties in Emotion Regulation Scale - 36 item version (DERS)	Difficulties in emotion regulation. Ranges from 36-180, with higher scores indicating more difficulties.	Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Secondary	the 21-item Depression Anxiety Stress Scales (DASS-21)	Symptoms of depression, anxiety and stress. Each subscale (depression, anxiety and stress) ranges from 0-21, with higher scores indicating more symptoms.	Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Secondary	Borderline Symptom List Supplement	Impulsive self-destructive behaviors	Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended
Secondary	Acceptance and Action Questionnaire	Acceptance and valued actions. Ranges from 7-49, with higher scores indicating less acceptance and valued actions.	Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Secondary	Childrens Global Assessment Scale	Global functioning. Ranges from 1-100, with higher scores indicating better functioning.	Change from baseline, 16 weeks after treatment starts, 3 months after treatment has ended
Secondary	The Clinical Global Impressions -Severity and Improvement scales	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.	Change from baseline, 16 weeks after treatment starts, 3 months after treatment has ended