Treatment Study for Non-Suicidal Self-Injury

NCT ID: NCT02060448

Last Updated: 2017-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Self Injurious Behavior Without Suicidal Intent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Emotion awareness training

Intervention Type BEHAVIORAL

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

Cognitive reappraisal

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Emotion awareness training

Intervention Type BEHAVIORAL

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

Cognitive reappraisal

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Emotion awareness training

Intervention Type BEHAVIORAL

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

Cognitive reappraisal

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Emotion awareness training

Intervention Type BEHAVIORAL

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

Cognitive reappraisal

Intervention Type BEHAVIORAL

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

Interventions

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Emotion awareness training

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

Intervention Type BEHAVIORAL

Cognitive reappraisal

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Boston University Charles River Campus

OTHER

Sponsor Role lead

Responsible Party

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Kate H. Bentley

Doctoral Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kate H Bentley, M.A.

Role: PRINCIPAL_INVESTIGATOR

Boston University

David H Barlow, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

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Center for Anxiety and Related Disorders, Boston University

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33884617 (View on PubMed)

Other Identifiers

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F31MH100761

Identifier Type: NIH

Identifier Source: secondary_id

View Link

F31MH100761

Identifier Type: NIH

Identifier Source: org_study_id

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