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Treatment Study for Non-Suicidal Self-Injury (NSSI)

Primary Purpose

Self Injurious Behavior Without Suicidal Intent

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotion awareness training
Cognitive reappraisal
Sponsored by
Boston University Charles River Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Self Injurious Behavior Without Suicidal Intent focused on measuring Non-suicidal self-injury, Self-injurious behavior, NSSI, Anxiety, Depression, Transdiagnostic, CBT, Unified Protocol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Anxiety and Related Disorders, Boston University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

2wk baseline + awareness (+ reappraisal)

2wk baseline + reappraisal (+ awareness)

4wk baseline + awareness (+ reappraisal)

4wk baseline + reappraisal + (awareness)

Arm Description

Participants 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.

Participants 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.

Participants 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.

Participants 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 7, 2014
Last Updated
March 19, 2017
Sponsor
Boston University Charles River Campus
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02060448
Brief Title
Treatment Study for Non-Suicidal Self-Injury
Acronym
NSSI
Official Title
Exploring Two Emotion-Focused Treatment Modules in Non-Suicidal Self-Injury
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University Charles River Campus
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self Injurious Behavior Without Suicidal Intent
Keywords
Non-suicidal self-injury, Self-injurious behavior, NSSI, Anxiety, Depression, Transdiagnostic, CBT, Unified Protocol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2wk baseline + awareness (+ reappraisal)
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
2wk baseline + reappraisal (+ awareness)
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
4wk baseline + awareness (+ reappraisal)
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
4wk baseline + reappraisal + (awareness)
Arm Type
Experimental
Arm Description
Participants 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.
Intervention Type
Behavioral
Intervention Name(s)
Emotion awareness training
Intervention Description
Four weekly individual treatment sessions focused on increasing awareness of one's emotions.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive reappraisal
Intervention Description
Four weekly individual treatment sessions focused on thinking about stimuli in a way that diminishes one's emotions.
Primary Outcome Measure Information:
Title
Frequency of non-suicidal self-injurious thoughts and behaviors
Description
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.
Time Frame
Daily (up to 126 days)
Secondary Outcome Measure Information:
Title
Overall Anxiety Severity and Impairment Scale (OASIS)
Time Frame
Weekly (up to 18 weeks)
Title
Overall Depression Severity and Impairment Scale (ODSIS)
Time Frame
Weekly (up to 18 weeks)
Title
Beck Anxiety Inventory (BAI)
Time Frame
Weekly (up to 18 weeks)
Title
Beck Depression Inventory (BDI-II)
Time Frame
Weekly (up to 18 weeks)
Title
Deficits in Emotion Regulation Scale (DERS): Emotion Awareness and Nonacceptance of Negative Emotional Responses subscales
Time Frame
Weekly (up to 18 weeks)
Title
Southampton Mindfulness Questionnaire (SMQ)
Time Frame
Weekly (up to 18 weeks)
Title
Multi-dimensional Experiential Avoidance Questionnaire (MEAQ): Distraction/Suppression subscale
Time Frame
Weekly (up to 18 weeks)
Title
Emotion Regulation Questionnaire (ERQ)
Time Frame
Weekly (up to 18 weeks)
Title
Insomnia Severity Index (ISI)
Description
Only three items of the ISI are included.
Time Frame
Weekly (up to 18 weeks)
Title
Subjective Symptoms Scale (SSS)
Time Frame
Weekly (up to 18 weeks)
Other Pre-specified Outcome Measures:
Title
Self-Injury Implicit Association Test (SI-IAT)
Description
The SI-IAT is a computerized behavioral test measures the implicit associations individuals hold about non-suicidal self-injury.
Time Frame
up to 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate H Bentley, M.A.
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David H Barlow, Ph.D.
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Anxiety and Related Disorders, Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33884617
Citation
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.
Results Reference
derived

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Treatment Study for Non-Suicidal Self-Injury

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