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

NCT04781166 | Terminated

• 1 other identifier: UC CPHS 2016-01-8287
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideation; Deliberate Self-harm; Impulsivity

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Change in aggression

  immediately before the intervention and one week after intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will be immediately assigned to the intervention.

Behavioral: Calm program

Waitlist control

OTHER

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

Interventions

Calm program BEHAVIORAL

7 online modules designed to teach cognitive behavioral skills

Intervention; Waitlist control

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Berkeley: lead

Study Sites (1)

University of California

Berkeley, California, 94720, United States

Location

MeSH Terms

Conditions

Suicidal Ideation; Self-Injurious Behavior; Impulsive Behavior

Condition Hierarchy (Ancestors)

Suicide; Behavioral Symptoms; Behavior

Study Officials

• Sheri L Johnson, Ph.D.

  professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Interview-based assessments will be conducted by personnel who are unaware of treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: March 4, 2021
• Study Start: April 15, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: We will upload data at the time we submit the article for publication. Data will be available for 7 years.
• Access Criteria: Data will be available to authorized users of the OSF website.

Locations

US (1)