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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03550521
Other study ID # IRB_00108383
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date June 1, 2019

Study information

Verified date April 2021
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 1, 2019
Est. primary completion date June 1, 2019
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Utah Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The Dot Probe Paradigm will be administered immediately preceding the mindfulness or control conditions and immediately following the mindfulness or control conditions
See also
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Completed NCT05935345 - Addressing Nonsuicidal Self-injury in Schools N/A
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Completed NCT02697019 - Internet-delivered Emotion Regulation Individual Therapy for Adolescents With NSSI - An Open Pilot Study N/A