An Online Intervention to Reduce Self-Harm Among Persons With High Emotion-Related Impulsivity
Primary Purpose
Suicidal Ideation, Deliberate Self-harm, Impulsivity
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Calm program
Sponsored by
About this trial
This is an interventional treatment trial for Suicidal Ideation
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.
Sites / Locations
- University of California
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention
Waitlist control
Arm Description
Participants will be immediately assigned to the intervention.
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.
Outcomes
Primary Outcome Measures
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.
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.
Change in self-rated suicidal ideation among adolescent patients
Suicide Ideation Questionnaire Jr; scores range from 0 to 6, where 6 is more severe
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)
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.
Change in impulsivity
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 impulsivity among adolescent patients
Urgency interview scores, scored as the sum of 8 items, range = 0 to 16, where higher scores reflect more impulsivity.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04781166
First Posted
February 19, 2021
Last Updated
August 17, 2022
Sponsor
University of California, Berkeley
1. Study Identification
Unique Protocol Identification Number
NCT04781166
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of recruitment
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Berkeley
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Deliberate Self-harm, Impulsivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
Interview-based assessments will be conducted by personnel who are unaware of treatment condition.
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants will be immediately assigned to the intervention.
Arm Title
Waitlist control
Arm Type
Other
Arm Description
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 Type
Behavioral
Intervention Name(s)
Calm program
Intervention Description
7 online modules designed to teach cognitive behavioral skills
Primary Outcome Measure Information:
Title
Change in suicidal ideation among adults
Description
Columbia Suicide Severity Rating scale suicidal ideation severity score; scores range from 0 to 5, where 5 is more severe.
Time Frame
immediately before the intervention and one week after intervention
Title
Change in interview-rated suicidal ideation among adolescent patients
Description
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.
Time Frame
immediately before the intervention and one week after intervention
Title
Change in self-rated suicidal ideation among adolescent patients
Description
Suicide Ideation Questionnaire Jr; scores range from 0 to 6, where 6 is more severe
Time Frame
immediately before the intervention and one week after intervention
Title
Change in self-rated deliberate self-harm
Description
Deliberate Self-Harm Inventory Frequency in past month score, from 0 to number of incidents reported (higher scores are worse outcomes)
Time Frame
immediately before the intervention and one week after intervention
Title
Change in interview-based self-harm among adolescent patients
Description
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.
Time Frame
immediately before the intervention and one week after intervention
Title
Change in impulsivity
Description
self-rated Three factor impulsivity Feelings Trigger Action subscale; scores range from 1 to 5, where 5 reflects more severe impulsivity
Time Frame
immediately before the intervention and one week after intervention
Title
Change in interview-based impulsivity among adolescent patients
Description
Urgency interview scores, scored as the sum of 8 items, range = 0 to 16, where higher scores reflect more impulsivity.
Time Frame
immediately before the intervention and one week after intervention
Secondary Outcome Measure Information:
Title
Change in aggression
Description
Bryant Aggression scale: mean of physical aggression, verbal aggression, and anger subscales; range of scores from 1 to 5, where 5 = more severe aggression
Time Frame
immediately before the intervention and one week after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheri L Johnson, Ph.D.
Organizational Affiliation
professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California
City
Berkeley
State/Province
California
ZIP/Postal Code
94720
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
An Online Intervention to Reduce Self-Harm Among Persons With High Emotion-Related Impulsivity
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