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

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.

Study Overview

• Status: Terminated
• Conditions: Suicidal Ideation; Impulsivity; Deliberate Self-harm
• Intervention / Treatment: Behavioral: Calm program

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94720
      • University of California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants will be immediately assigned to the intervention.	Behavioral: Calm program; 7 online modules designed to teach cognitive behavioral skills
Other: 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.	Behavioral: Calm program; 7 online modules designed to teach cognitive behavioral skills

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, Berkeley
• Investigators: Principal Investigator: Sheri L Johnson, Ph.D., Professor

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: February 19, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Wounds and Injuries; Suicide; Suicidal Ideation; Self-Injurious Behavior; Impulsive Behavior; Self Mutilation
• Other Study ID Numbers: UC CPHS 2016-01-8287

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will provide fully de-identified data on OSF.
• IPD Sharing Time Frame: We will upload data at the time we submit the article for publication. Data will be available for 7 years.
• IPD Sharing Access Criteria: Data will be available to authorized users of the OSF website.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No