Back to resultsInterrupting Self-Harm Study
Primary Purpose
Nonsuicidal Self-injury
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness
Sponsored by
About this trial
This is an interventional treatment trial for Nonsuicidal Self-injury
Eligibility Criteria
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.
Sites / Locations
- University of Utah
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mindfulness condition
Control condition
Arm Description
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.
Participants assigned to the control task will be instructed to "let your mind wander freely without trying to focus on anything in particular."
Outcomes
Primary Outcome Measures
Change in self-injury attentional bias as measured by a Dot Probe Paradigm
Attentional bias (AB) refers to the allocation of attentional resources to specific aspects of environmental stimuli
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03550521
Brief Title
Interrupting Self-Harm Study
Official Title
A Mixed Methods Investigation of Brief Mindfulness Training and Self-injury Attentional Bias Among Self-injuring Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
PI left
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah
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
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonsuicidal Self-injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Control condition
Arm Type
No Intervention
Arm Description
Participants assigned to the control task will be instructed to "let your mind wander freely without trying to focus on anything in particular."
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in self-injury attentional bias as measured by a Dot Probe Paradigm
Description
Attentional bias (AB) refers to the allocation of attentional resources to specific aspects of environmental stimuli
Time Frame
The Dot Probe Paradigm will be administered immediately preceding the mindfulness or control conditions and immediately following the mindfulness or control conditions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael R Riquino, MSW
Organizational Affiliation
University of Utah College of Social Work
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33677832
Citation
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3(3):CD013667. doi: 10.1002/14651858.CD013667.pub2.
Results Reference
derived
Learn more about this trial
Interrupting Self-Harm Study
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