Treatment Study for Non-Suicidal Self-Injury

Self Injurious Behavior Without Suicidal Intent Clinical Trial

— NSSI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060448
• Other study ID #: F31MH100761
• Secondary ID: F31MH100761
• Status: Completed
• Phase: N/A
• First received: February 7, 2014
• Last updated: March 19, 2017
• Start date: November 2013
• Est. completion date: December 2015

Study information

• Verified date: March 2017
• Source: Boston University Charles River Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Self Injurious Behavior Without Suicidal Intent
• Self-Injurious Behavior

Intervention

Behavioral:
• Emotion awareness training
Four weekly individual treatment sessions focused on increasing awareness of one's emotions.
• Cognitive reappraisal
Four weekly individual treatment sessions focused on thinking about stimuli in a way that diminishes one's emotions.

Locations

Country	Name	City	State
United States	Center for Anxiety and Related Disorders, Boston University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University Charles River Campus	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-Injury Implicit Association Test (SI-IAT)	The SI-IAT is a computerized behavioral test measures the implicit associations individuals hold about non-suicidal self-injury.	up to 18 weeks
Primary	Frequency of non-suicidal self-injurious thoughts and behaviors	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.	Daily (up to 126 days)
Secondary	Overall Anxiety Severity and Impairment Scale (OASIS)		Weekly (up to 18 weeks)
Secondary	Overall Depression Severity and Impairment Scale (ODSIS)		Weekly (up to 18 weeks)
Secondary	Beck Anxiety Inventory (BAI)		Weekly (up to 18 weeks)
Secondary	Beck Depression Inventory (BDI-II)		Weekly (up to 18 weeks)
Secondary	Deficits in Emotion Regulation Scale (DERS): Emotion Awareness and Nonacceptance of Negative Emotional Responses subscales		Weekly (up to 18 weeks)
Secondary	Southampton Mindfulness Questionnaire (SMQ)		Weekly (up to 18 weeks)
Secondary	Multi-dimensional Experiential Avoidance Questionnaire (MEAQ): Distraction/Suppression subscale		Weekly (up to 18 weeks)
Secondary	Emotion Regulation Questionnaire (ERQ)		Weekly (up to 18 weeks)
Secondary	Insomnia Severity Index (ISI)	Only three items of the ISI are included.	Weekly (up to 18 weeks)
Secondary	Subjective Symptoms Scale (SSS)		Weekly (up to 18 weeks)