Interrupting Self-Harm Study

NCT03550521 | Withdrawn

• 1 other identifier: IRB_00108383
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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?

Conditions

Nonsuicidal Self-injury

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Mindfulness condition

EXPERIMENTAL

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

Control condition

NO INTERVENTION

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

Interventions

Mindfulness BEHAVIORAL

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.

Mindfulness condition

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• 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.

  PMID: 33677832 DERIVED

MeSH Terms

Conditions

Self-Injurious Behavior

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Michael R Riquino, MSW

  University of Utah College of Social Work

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: June 8, 2018
• Study Start: June 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)