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

Suicidal Ideation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04781166
• Other study ID #: UC CPHS 2016-01-8287
• Status: Terminated
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: November 2023
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deliberate Self-harm
• Impulsive Behavior
• Impulsivity
• Self Mutilation
• Self-Injurious Behavior
• Suicidal Ideation

Intervention

Behavioral:
• Calm program
7 online modules designed to teach cognitive behavioral skills

Locations

Country	Name	City	State
United States	University of California	Berkeley	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Berkeley

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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