An Online Intervention to Reduce Self-Harm Among Persons With High Emotion-Related
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Change in suicidal ideation among adults
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Interview-based assessments will be conducted by personnel who are unaware of treatment condition.
Eligibility Criteria
- Ages
- 13 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Intervention
Participants will be immediately assigned to the intervention.
Intervention: Calm program (Behavioral)
Waitlist control
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 (Behavioral)
Outcomes
Primary Outcomes
Change in suicidal ideation among adults
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Change in aggression(immediately before the intervention and one week after intervention)
Investigators
Sheri L. Johnson
Professor
University of California, Berkeley