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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Suicidal Ideation, Deliberate Self-harm, Impulsivity

Intervention / Treatment
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* Behavioral: Calm program


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Adult participants will be enrolled in the intervention, and we will use pre-, post-data to evaluate whether the program appears to be helpful. Adolescent participants will be randomly assigned to a waitlist control or intervention; those in the waitlist will be offered the intervention after they complete the waitlist period.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants will be immediately assigned to the intervention. | Behavioral: Calm program<br>* 7 online modules designed to teach cognitive behavioral skills<br>|
| Other: Waitlist control<br>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. | Behavioral: Calm program<br>* 7 online modules designed to teach cognitive behavioral skills<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in suicidal ideation among adults | Columbia Suicide Severity Rating scale suicidal ideation severity score; scores range from 0 to 5, where 5 is more severe. | immediately before the intervention and one week after intervention | 
| Change in interview-rated suicidal ideation among adolescent patients | 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. | immediately before the intervention and one week after intervention | 
| Change in self-rated suicidal ideation among adolescent patients | Suicide Ideation Questionnaire Jr; scores range from 0 to 6, where 6 is more severe | immediately before the intervention and one week after intervention | 
| Change in self-rated deliberate self-harm | Deliberate Self-Harm Inventory Frequency in past month score, from 0 to number of incidents reported (higher scores are worse outcomes) | immediately before the intervention and one week after intervention | 
| Change in interview-based self-harm among adolescent patients | 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. | immediately before the intervention and one week after intervention | 
| Change in impulsivity | self-rated Three factor impulsivity Feelings Trigger Action subscale; scores range from 1 to 5, where 5 reflects more severe impulsivity | immediately before the intervention and one week after intervention | 
| Change in interview-based impulsivity among adolescent patients | Urgency interview scores, scored as the sum of 8 items, range = 0 to 16, where higher scores reflect more impulsivity. | immediately before the intervention and one week after intervention | 

Secondary Outcome Measures

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