Interrupting Self-Harm Study

Sponsor

University of Utah (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03550521

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

My study will employ a convergent mixed methods two-arm parallel randomized controlled design. The qualitative strand will primarily rely on semi-structured interview procedures to answer the following questions: (1) How do adolescents perceive and experience the phenomenon of nonsuicidal self-injury (NSSI)? (2) What do adolescents believe needs to be done to address NSSI? The quantitative strand will primarily rely on clinical interview data, self-report measures, and an experimental task protocol to answer the following question: What is the impact of a brief mindfulness induction (versus a control condition) on self-injury attentional bias among self-injuring adolescents?

Condition or Disease	Intervention/Treatment	Phase
Nonsuicidal Self-injury	Behavioral: Mindfulness	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

A Mixed Methods Investigation of Brief Mindfulness Training and Self-injury Attentional Bias Among Self-injuring Adolescents

Actual Study Start Date :

Jun 1, 2018

Actual Primary Completion Date :

Jun 1, 2019

Actual Study Completion Date :

Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindfulness condition The brief mindfulness induction will be modeled after basic mindfulness skills commonly used in mindfulness-based interventions and tailored to target distressing thoughts and feelings.	Behavioral: Mindfulness Participants will be instructed to focus on the sensations of breathing. Subsequently, whenever their minds wander to distressing thoughts or emotions, they will be instructed to acknowledge those thoughts or emotions, and then bring their attention back to the sensations of breathing.
No Intervention: Control condition Participants assigned to the control task will be instructed to "let your mind wander freely without trying to focus on anything in particular."

Arm

Intervention/Treatment

Experimental: Mindfulness condition

The brief mindfulness induction will be modeled after basic mindfulness skills commonly used in mindfulness-based interventions and tailored to target distressing thoughts and feelings.

Behavioral: Mindfulness

Participants will be instructed to focus on the sensations of breathing. Subsequently, whenever their minds wander to distressing thoughts or emotions, they will be instructed to acknowledge those thoughts or emotions, and then bring their attention back to the sensations of breathing.

No Intervention: Control condition

Participants assigned to the control task will be instructed to "let your mind wander freely without trying to focus on anything in particular."

Outcome Measures

Primary Outcome Measures

Change in self-injury attentional bias as measured by a Dot Probe Paradigm [The Dot Probe Paradigm will be administered immediately preceding the mindfulness or control conditions and immediately following the mindfulness or control conditions]
Attentional bias (AB) refers to the allocation of attentional resources to specific aspects of environmental stimuli

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

To be included in the study, a participant must be: 1) at least 12 years old and no more than 18 years old, 2) able to understand and communicate in English, 3) willing and able to participate in all study procedures, and 4) currently engaging in nonsuicidal self-injury OR have a history of nonsuicidal self-injury.

Exclusion Criteria:

Individuals will be excluded from the study if they are experiencing a suicidal crisis at the time of the study procedures (e.g., they endorse suicidal ideation, planning, and intent as determined by the Mini International Neuropsychiatric Interview 7.0) and require crisis intervention or hospitalization.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Utah	Salt Lake City	Utah	United States	84112

Sponsors and Collaborators

University of Utah

Investigators

Principal Investigator: Michael R Riquino, MSW, University of Utah College of Social Work

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Utah

ClinicalTrials.gov Identifier:

NCT03550521

Other Study ID Numbers:

IRB_00108383

First Posted:

Jun 8, 2018

Last Update Posted:

Apr 28, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Self-Injurious Behavior

Study Results

No Results Posted as of Apr 28, 2021