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

NCT ID: NCT04781166

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2021-10-01

Brief Summary

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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

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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.

Conditions

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Suicidal Ideation Deliberate Self-harm Impulsivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Interview-based assessments will be conducted by personnel who are unaware of treatment condition.

Study Groups

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Intervention

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Group Type EXPERIMENTAL

Calm program

Intervention Type BEHAVIORAL

7 online modules designed to teach cognitive behavioral skills

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.

Group Type OTHER

Calm program

Intervention Type BEHAVIORAL

7 online modules designed to teach cognitive behavioral skills

Interventions

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Calm program

7 online modules designed to teach cognitive behavioral skills

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Berkeley

OTHER

Sponsor Role lead

Responsible Party

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Sheri L. Johnson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sheri L Johnson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

professor

Locations

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University of California

Berkeley, California, United States

Site Status

Countries

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United States

Other Identifiers

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UC CPHS 2016-01-8287

Identifier Type: -

Identifier Source: org_study_id

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