Treatment Study for Non-Suicidal Self-Injury
NSSI
Exploring Two Emotion-Focused Treatment Modules in Non-Suicidal Self-Injury
1 other identifier
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 7, 2014
CompletedFirst Posted
Study publicly available on registry
February 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 21, 2017
March 1, 2017
2.1 years
February 7, 2014
March 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
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 subscales
Weekly (up to 18 weeks)
- +5 more secondary outcomes
Other Outcomes (1)
Self-Injury Implicit Association Test (SI-IAT)
up to 18 weeks
Study Arms (4)
2wk baseline + awareness (+ reappraisal)
EXPERIMENTALParticipants in this arm will first undergo a two-week baseline phase. Participants who evidence a significant decrease in non-suicidal self-injurious thoughts and behaviors, or SITBs, (i.e., "responders") after emotion awareness training will go straight to a four-week follow-up, and not receive cognitive reappraisal. Participants who evidence a less than satisfactory response in non-suicidal SITBs (i.e., "partial responders") after emotion awareness training will return to a two-week baseline phase before receiving cognitive reappraisal, and then enter a four-week follow-up. Participants who evidence little to no response in non-suicidal SITBs (i.e., "non-responders") after emotion awareness training will immediately receive cognitive reappraisal and then enter a four-week follow-up.
2wk baseline + reappraisal (+ awareness)
EXPERIMENTALParticipants will first undergo a two-week baseline phase. Participants who evidence a significant decrease in non-suicidal SITBs (i.e., "responders") after cognitive reappraisal will go straight to a four-week follow-up, and not receive emotion awareness training. Participants who evidence a less than satisfactory response in non-suicidal SITBs (i.e., "partial responders") after cognitive reappraisal will return to a two-week baseline phase before receiving emotion awareness training, and then enter a four-week follow-up. Participants who evidence little to no response in non-suicidal SITBs and behaviors (i.e., "non-responders") after cognitive reappraisal will immediately receive emotion awareness training and then enter a four-week follow-up.
4wk baseline + awareness (+ reappraisal)
EXPERIMENTALParticipants in this arm will first undergo a four-week baseline phase. Participants who evidence a significant decrease in non-suicidal SITBs (i.e., "responders") after emotion awareness training will go straight to a four-week follow-up, and not receive cognitive reappraisal. Participants who evidence a less than satisfactory response in non-suicidal SITBs (i.e., "partial responders") after emotion awareness training will return to a two-week baseline phase before receiving cognitive reappraisal, and then enter a four-week follow-up. Participants who evidence little to no response in non-suicidal SITBs (i.e., "non-responders") after emotion awareness training will immediately receive cognitive reappraisal and then enter a four-week follow-up.
4wk baseline + reappraisal + (awareness)
EXPERIMENTALParticipants in this arm will first undergo a four-week baseline phase. Participants who evidence a significant decrease in non-suicidal SITBs (i.e., "responders") after cognitive reappraisal will go straight to a four-week follow-up, and not receive emotion awareness training. Participants who evidence a less than satisfactory response in non-suicidal SITBs (i.e., "partial responders") after cognitive reappraisal will return to a two-week baseline phase before receiving emotion awareness training, and then enter a four-week follow-up. Participants who evidence little to no response in non-suicidal SITBs (i.e., "non-responders") after cognitive reappraisal will immediately receive emotion awareness training and then enter a four-week follow-up.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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:
- five or more days in which the individual has engaged in NSSI in the past year
- 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)
- clinically significant distress or interference caused by NSSI or its consequences
- NSSI does not occur exclusively during states of psychosis, delirium, or intoxication
- absence of suicidal intent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Anxiety and Related Disorders, Boston University
Boston, Massachusetts, 02215, United States
Related Publications (1)
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
PMID: 33884617DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kate H Bentley, M.A.
Boston University
- PRINCIPAL INVESTIGATOR
David H Barlow, Ph.D.
Boston University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctoral Candidate
Study Record Dates
First Submitted
February 7, 2014
First Posted
February 12, 2014
Study Start
November 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
March 21, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share