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Treatment Study for Non-Suicidal Self-Injury

Exploring Two Emotion-Focused Treatment Modules in Non-Suicidal Self-Injury

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02060448
Acronym
NSSI
Enrollment
13
Registered
2014-02-12
Start date
2013-11-30
Completion date
2015-12-31
Last updated
2017-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Self Injurious Behavior Without Suicidal Intent

Keywords

Non-suicidal self-injury, Self-injurious behavior, NSSI, Anxiety, Depression, Transdiagnostic, CBT, Unified Protocol

Brief summary

The overall aim of this study is to begin establishing an effective treatment for individuals who engage in non-suicidal self-injury (NSSI), as there are currently no evidence-based treatments that directly target this problematic behavior. Existing treatments that have demonstrated initial promise in reducing NSSI consist of many skills embedded in complex programs; therefore, the skill(s) responsible for improvements in NSSI are not clear. Procedures that focus on one's emotions, particularly that aim to increase emotional awareness and engagement in cognitive reappraisal (i.e., a way of thinking that lessens emotions), may be critical in effective NSSI treatment. The specific goals of this study are to investigate the effects of two specific emotion-focused treatment elements on NSSI. Participants will be ten individuals who meet the proposed Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5; American Psychiatric Association) criteria for NSSI disorder and engage in NSSI to reduce or escape from negative emotions. Two core modules of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al., 2011) will be adapted and delivered with the aim of reducing participants' non-suicidal self-injurious thoughts and behaviors. Each treatment module will consist of four 50-minute individual weekly sessions of emotion awareness training or cognitive reappraisal. The study will use a single-case experimental design, and phase change will be determined based on each participant's changes in non-suicidal self-injurious thoughts and behaviors.

Interventions

BEHAVIORALEmotion awareness training

Four weekly individual treatment sessions focused on increasing awareness of one's emotions.

Four weekly individual treatment sessions focused on thinking about stimuli in a way that diminishes one's emotions.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Boston University Charles River Campus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* At least 18 years old * Engage in non-suicidal self-injury (NSSI) to reduce or lessen negative thoughts or feelings * Not taking psychotropic medications, or meet criteria for stability on a particular dose and are willing to maintain a stable dosage throughout the study * Meet the proposed Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for NSSI disorder, which includes: 1. five or more days in which the individual has engaged in NSSI in the past year 2. NSSI is associated with at least two two of the following: psychological precipitant (e.g., negative feelings or thoughts), urge prior to the act, preoccupation with NSSI, contingent response (e.g., expectation that the act will relieve a negative feeling state) 3. clinically significant distress or interference caused by NSSI or its consequences 4. NSSI does not occur exclusively during states of psychosis, delirium, or intoxication 5. absence of suicidal intent

Exclusion criteria

* Current suicidal ideation and intent * Currently receiving cognitive-behavioral therapy (CBT) or any psychotherapy to address NSSI, anxiety, depression, or other Axis I disorders (and are not willing to discontinue that treatment) * Unwilling to refrain from initiating additional treatment during the course of the study * Current or very recent symptoms that warrant immediate clinical attention, alternative treatment, and/or a higher level of care that cannot be provided through the study (e.g., florid delusions or hallucinations, rapid mood state, severe manic symptoms) * Current or recent (within 3 months) history of substance use disorder (exception would be marijuana, caffeine, nicotine) * Emotional symptomatology is due to a medical/physical condition

Design outcomes

Primary

MeasureTime frameDescription
Frequency of non-suicidal self-injurious thoughts and behaviorsDaily (up to 126 days)Frequency of non-suicidal self-injurious thoughts and behaviors will be indicated by participants' responses to electronic questions delivered through a smart phone daily, assessed up to 126 days.

Secondary

MeasureTime frameDescription
Overall Anxiety Severity and Impairment Scale (OASIS)Weekly (up to 18 weeks)
Overall Depression Severity and Impairment Scale (ODSIS)Weekly (up to 18 weeks)
Beck Anxiety Inventory (BAI)Weekly (up to 18 weeks)
Beck Depression Inventory (BDI-II)Weekly (up to 18 weeks)
Deficits in Emotion Regulation Scale (DERS): Emotion Awareness and Nonacceptance of Negative Emotional Responses subscalesWeekly (up to 18 weeks)
Multi-dimensional Experiential Avoidance Questionnaire (MEAQ): Distraction/Suppression subscaleWeekly (up to 18 weeks)
Emotion Regulation Questionnaire (ERQ)Weekly (up to 18 weeks)
Insomnia Severity Index (ISI)Weekly (up to 18 weeks)Only three items of the ISI are included.
Subjective Symptoms Scale (SSS)Weekly (up to 18 weeks)
Southampton Mindfulness Questionnaire (SMQ)Weekly (up to 18 weeks)

Other

MeasureTime frameDescription
Self-Injury Implicit Association Test (SI-IAT)up to 18 weeksThe SI-IAT is a computerized behavioral test measures the implicit associations individuals hold about non-suicidal self-injury.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026