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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04781166
Enrollment
2
Registered
2021-03-04
Start date
2021-04-15
Completion date
2021-10-01
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deliberate Self-harm, Impulsivity, Suicidal Ideation

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.

Interventions

BEHAVIORALCalm program

7 online modules designed to teach cognitive behavioral skills

Sponsors

University of California, Berkeley
Lead SponsorOTHER

Study design

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.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
13 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Change in suicidal ideation among adultsimmediately before the intervention and one week after interventionColumbia Suicide Severity Rating scale suicidal ideation severity score; scores range from 0 to 5, where 5 is more severe.
Change in interview-rated suicidal ideation among adolescent patientsimmediately before the intervention and one week after interventionSelf-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 patientsimmediately before the intervention and one week after interventionSuicide Ideation Questionnaire Jr; scores range from 0 to 6, where 6 is more severe
Change in self-rated deliberate self-harmimmediately before the intervention and one week after interventionDeliberate Self-Harm Inventory Frequency in past month score, from 0 to number of incidents reported (higher scores are worse outcomes)
Change in interview-based self-harm among adolescent patientsimmediately before the intervention and one week after interventionSelf-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 impulsivityimmediately before the intervention and one week after interventionself-rated Three factor impulsivity Feelings Trigger Action subscale; scores range from 1 to 5, where 5 reflects more severe impulsivity
Change in interview-based impulsivity among adolescent patientsimmediately before the intervention and one week after interventionUrgency interview scores, scored as the sum of 8 items, range = 0 to 16, where higher scores reflect more impulsivity.

Secondary

MeasureTime frameDescription
Change in aggressionimmediately before the intervention and one week after interventionBryant Aggression scale: mean of physical aggression, verbal aggression, and anger subscales; range of scores from 1 to 5, where 5 = more severe aggression

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026