An Online Intervention to Reduce Self-Harm Among Persons With High Emotion-Related Impulsivity

Not Applicable

Terminated

• Conditions: Deliberate Self-harm; Impulsivity; Suicidal Ideation
• Interventions: Behavioral: Calm program

• Registration Number: NCT04781166
• Lead Sponsor: University of California, Berkeley

Brief Summary

The goal of this program is to test a brief, online, cognitive behavioral intervention for people who struggle with self-harm or suicidal urges or behavior in the context of emotion-related impulsivity.

Detailed Description

Participants will be asked to complete 7 brief online modules to cover how to understand emotion-triggered impulsivity, to better detect states of high emotion and arousal, to learn new strategies for self-calming high arousal, and to pre-plan how to cope with high arousal states. As part of the program, participants receive daily texts and prompts to remind them of the intervention content and skills. At baseline and follow-up, participants will complete measures of emotion-related impulsivity, self-harm, and suicidality.

Study Timeline

• Study First Submitted: 2021-02-19
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-04
• Study Start: 2021-04-15
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• at least 13 years of age
• engaged in mental health care
• evidence of either self-harm or suicidal urges or behavior in the past 3 months
• high levels of emotion-related impulsivity.

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Exclusion Criteria

• inability to adequately take part in the online measures due to problems with intellectual function, language, or other conditions,
• psychosis,
• not currently living in California,
• lack of access to a device to privately complete online modules.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Waitlist control	Calm program	Participants will complete measures before and after a waitlist equivalent to the duration of the intervention, to assess whether change is observed with time and repeated assessment. After the waitlist control, participants will be provided the opportunity to take part in the intervention. In this RDICT design, the pre- post- treatment data will be included in analyses.
Intervention	Calm program	Participants will be immediately assigned to the intervention.

Primary Outcome Measures

Name	Time	Method
Change in suicidal ideation among adults	immediately before the intervention and one week after intervention	Columbia Suicide Severity Rating scale suicidal ideation severity score; scores range from 0 to 5, where 5 is more severe.
Change in self-rated deliberate self-harm	immediately before the intervention and one week after intervention	Deliberate Self-Harm Inventory Frequency in past month score, from 0 to number of incidents reported (higher scores are worse outcomes)
Change in interview-rated suicidal ideation among adolescent patients	immediately before the intervention and one week after intervention	Self-Injurious Thoughts and Behaviors Interview suicidal ideation in the past month scored as the sum of the items on the worst intensity, average intensity, and likelihood of suicidal ideation items; scores range from 0 to 12, with higher scores reflecting greater severity.
Change in self-rated suicidal ideation among adolescent patients	immediately before the intervention and one week after intervention	Suicide Ideation Questionnaire Jr; scores range from 0 to 6, where 6 is more severe
Change in impulsivity	immediately before the intervention and one week after intervention	self-rated Three factor impulsivity Feelings Trigger Action subscale; scores range from 1 to 5, where 5 reflects more severe impulsivity
Change in interview-based self-harm among adolescent patients	immediately before the intervention and one week after intervention	Self-Injurious Thoughts and Behaviors Interview NSSI severity in the past month, scored as the sum of the items on the worst intensity, average intensity, and likelihood of NSSI items; scores range from 0 to 12 with higher scores reflecting greater severity.
Change in interview-based impulsivity among adolescent patients	immediately before the intervention and one week after intervention	Urgency interview scores, scored as the sum of 8 items, range = 0 to 16, where higher scores reflect more impulsivity.

Secondary Outcome Measures

Name	Time	Method
Change in aggression	immediately before the intervention and one week after intervention	Bryant Aggression scale: mean of physical aggression, verbal aggression, and anger subscales; range of scores from 1 to 5, where 5 = more severe aggression

Trial Locations

Locations (1)

University of California; 🇺🇸 Berkeley, California, United States