Clinical trial NCT04781166: An Online Intervention to Reduce Self-Harm Among Persons With High Emotion-Related Impulsivity
Official title: An Online Intervention to Reduce Self-Harm Among Persons With High Emotion-Related
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Suicidal Ideation
Deliberate Self-harm
Impulsivity
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 2
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in suicidal ideation among adults
timeFrame: immediately before the intervention and one week after intervention
measure: Change in interview-rated suicidal ideation among adolescent patients
timeFrame: immediately before the intervention and one week after intervention
measure: Change in self-rated suicidal ideation among adolescent patients
timeFrame: immediately before the intervention and one week after intervention
measure: Change in self-rated deliberate self-harm
timeFrame: immediately before the intervention and one week after intervention
measure: Change in interview-based self-harm among adolescent patients
timeFrame: immediately before the intervention and one week after intervention
measure: Change in impulsivity
timeFrame: immediately before the intervention and one week after intervention
measure: Change in interview-based impulsivity among adolescent patients
timeFrame: immediately before the intervention and one week after intervention
Secondary outcomes:
measure: Change in aggression
timeFrame: immediately before the intervention and one week after intervention
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: University of California
state: California
Study officials:
affiliation: professor
name: Sheri L Johnson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: