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

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ClinicalTrials.gov Identifier: NCT02060448
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : March 21, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Kate H. Bentley, Boston University Charles River Campus

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.

Condition or disease Intervention/treatment Phase
Self Injurious Behavior Without Suicidal Intent Behavioral: Emotion awareness training Behavioral: Cognitive reappraisal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploring Two Emotion-Focused Treatment Modules in Non-Suicidal Self-Injury
Study Start Date : November 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Self-Harm

Arm Intervention/treatment
Experimental: 2wk baseline + awareness (+ reappraisal)
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.
Behavioral: Emotion awareness training
Four weekly individual treatment sessions focused on increasing awareness of one's emotions.

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

Experimental: 2wk baseline + reappraisal (+ awareness)
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.
Behavioral: Emotion awareness training
Four weekly individual treatment sessions focused on increasing awareness of one's emotions.

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

Experimental: 4wk baseline + awareness (+ reappraisal)
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.
Behavioral: Emotion awareness training
Four weekly individual treatment sessions focused on increasing awareness of one's emotions.

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

Experimental: 4wk baseline + reappraisal + (awareness)
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.
Behavioral: Emotion awareness training
Four weekly individual treatment sessions focused on increasing awareness of one's emotions.

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




Primary Outcome Measures :
  1. Frequency of non-suicidal self-injurious thoughts and behaviors [ Time Frame: Daily (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 Outcome Measures :
  1. Overall Anxiety Severity and Impairment Scale (OASIS) [ Time Frame: Weekly (up to 18 weeks) ]
  2. Overall Depression Severity and Impairment Scale (ODSIS) [ Time Frame: Weekly (up to 18 weeks) ]
  3. Beck Anxiety Inventory (BAI) [ Time Frame: Weekly (up to 18 weeks) ]
  4. Beck Depression Inventory (BDI-II) [ Time Frame: Weekly (up to 18 weeks) ]
  5. Deficits in Emotion Regulation Scale (DERS): Emotion Awareness and Nonacceptance of Negative Emotional Responses subscales [ Time Frame: Weekly (up to 18 weeks) ]
  6. Southampton Mindfulness Questionnaire (SMQ) [ Time Frame: Weekly (up to 18 weeks) ]
  7. Multi-dimensional Experiential Avoidance Questionnaire (MEAQ): Distraction/Suppression subscale [ Time Frame: Weekly (up to 18 weeks) ]
  8. Emotion Regulation Questionnaire (ERQ) [ Time Frame: Weekly (up to 18 weeks) ]
  9. Insomnia Severity Index (ISI) [ Time Frame: Weekly (up to 18 weeks) ]
    Only three items of the ISI are included.

  10. Subjective Symptoms Scale (SSS) [ Time Frame: Weekly (up to 18 weeks) ]

Other Outcome Measures:
  1. Self-Injury Implicit Association Test (SI-IAT) [ Time Frame: up to 18 weeks ]
    The SI-IAT is a computerized behavioral test measures the implicit associations individuals hold about non-suicidal self-injury.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060448


Locations
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United States, Massachusetts
Center for Anxiety and Related Disorders, Boston University
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Boston University Charles River Campus
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Kate H Bentley, M.A. Boston University
Principal Investigator: David H Barlow, Ph.D. Boston University

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Responsible Party: Kate H. Bentley, Doctoral Candidate, Boston University Charles River Campus
ClinicalTrials.gov Identifier: NCT02060448     History of Changes
Other Study ID Numbers: F31MH100761 ( U.S. NIH Grant/Contract )
F31MH100761 ( U.S. NIH Grant/Contract )
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kate H. Bentley, Boston University Charles River Campus:
Non-suicidal self-injury
Self-injurious behavior
NSSI
Anxiety
Depression
Transdiagnostic
CBT
Unified Protocol

Additional relevant MeSH terms:
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Self-Injurious Behavior
Behavioral Symptoms