Self Injurious Behavior Without Suicidal IntentNSSINCT02060448

Treatment Study for Non-Suicidal Self-Injury

A study testing Emotion awareness training and Cognitive reappraisal in people with Self Injurious Behavior Without Suicidal Intent, run by Boston University Charles River Campus at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Self Injurious Behavior Without Suicidal Intent
What is being tested?: Emotion awareness training and Cognitive reappraisal
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteUnited States
Study dates: Nov 2013to Dec 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

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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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Center for Anxiety and Related Disorders, Boston University
Boston, Massachusetts, 02215

Other trials in United States

About this study

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

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.

Conditions: Self Injurious Behavior Without Suicidal Intent
Being tested: Emotion awareness training, Cognitive reappraisal
Keywords: Non-suicidal self-injury, Self-injurious behavior, NSSI, Anxiety, Depression, Transdiagnostic, CBT, Unified Protocol
Medical subject headings: Self-Injurious Behavior, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Emotion awareness trainingBehavioural
Four weekly individual treatment sessions focused on increasing awareness of one's emotions.
Cognitive reappraisalBehavioural
Four weekly individual treatment sessions focused on thinking about stimuli in a way that diminishes one's emotions.

Study groups in NCT02060448
Study group	Role	What they receive
2wk baseline + awareness (+ reappraisal)	Experimental	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. Receives: Behavioral: Emotion awareness training; Behavioral: Cognitive reappraisal
2wk baseline + reappraisal (+ awareness)	Experimental	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. Receives: Behavioral: Emotion awareness training; Behavioral: Cognitive reappraisal
4wk baseline + awareness (+ reappraisal)	Experimental	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. Receives: Behavioral: Emotion awareness training; Behavioral: Cognitive reappraisal
4wk baseline + reappraisal + (awareness)	Experimental	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. Receives: Behavioral: Emotion awareness training; Behavioral: Cognitive reappraisal

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Daily (up to 126 days)

Secondary outcomes (10)

Overall Anxiety Severity and Impairment Scale (OASIS)
Measured: Weekly (up to 18 weeks)
Overall Depression Severity and Impairment Scale (ODSIS)
Measured: Weekly (up to 18 weeks)
Beck Anxiety Inventory (BAI)
Measured: Weekly (up to 18 weeks)
Beck Depression Inventory (BDI-II)
Measured: Weekly (up to 18 weeks)
Deficits in Emotion Regulation Scale (DERS): Emotion Awareness and Nonacceptance of Negative Emotional Responses subscales
Measured: Weekly (up to 18 weeks)
Southampton Mindfulness Questionnaire (SMQ)
Measured: Weekly (up to 18 weeks)
Multi-dimensional Experiential Avoidance Questionnaire (MEAQ): Distraction/Suppression subscale
Measured: Weekly (up to 18 weeks)
Emotion Regulation Questionnaire (ERQ)
Measured: Weekly (up to 18 weeks)
Insomnia Severity Index (ISI)
Only three items of the ISI are included.
Measured: Weekly (up to 18 weeks)
Subjective Symptoms Scale (SSS)
Measured: Weekly (up to 18 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2013Dec 2015

First posted12 Feb 2014 (estimated)
Study startNov 2013
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Self Injurious Behavior Without Suicidal IntentStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02060448
Sponsor's protocol ID: F31MH100761
Other IDs: F31MH100761
Acronym: NSSI
Status last verified: Mar 2017
First submitted: 7 Feb 2014
Last updated: 21 Mar 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 33884617

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exploring Two Emotion-Focused Treatment Modules in Non-Suicidal Self-Injury
ClinicalTrials.gov ID: NCT02060448
Acronym / sponsor ID: NSSI / F31MH100761
Conditions: Self Injurious Behavior Without Suicidal Intent
Keywords: Non-suicidal self-injury, Self-injurious behavior, NSSI, Anxiety, Depression, Transdiagnostic, CBT, Unified Protocol
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Boston University Charles River CampusUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Nov 2013
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 12 Feb 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
2wk baseline + awareness (+ reappraisal)	Experimental	Behavioral: Emotion awareness training, Behavioral: Cognitive reappraisalParticipants 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)	Experimental	Behavioral: Emotion awareness training, Behavioral: Cognitive reappraisalParticipants 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)	Experimental	Behavioral: Emotion awareness training, Behavioral: Cognitive reappraisalParticipants 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)	Experimental	Behavioral: Emotion awareness training, Behavioral: Cognitive reappraisalParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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:

Key exclusion criteria (6 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Emotion awareness trainingFour weekly individual treatment sessions focused on increasing awareness of one's emotions.	Behavioural	2wk baseline + awareness (+ reappraisal), 2wk baseline + reappraisal (+ awareness), 4wk baseline + awareness (+ reappraisal), 4wk baseline + reappraisal + (awareness)
Cognitive reappraisalFour weekly individual treatment sessions focused on thinking about stimuli in a way that diminishes one's emotions.	Behavioural	2wk baseline + awareness (+ reappraisal), 2wk baseline + reappraisal (+ awareness), 4wk baseline + awareness (+ reappraisal), 4wk baseline + reappraisal + (awareness)

Primary outcome

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.

10 secondary outcomes

Overall Anxiety Severity and Impairment Scale (OASIS)
Time frame: Weekly (up to 18 weeks)
Overall Depression Severity and Impairment Scale (ODSIS)
Time frame: Weekly (up to 18 weeks)
Beck Anxiety Inventory (BAI)
Time frame: Weekly (up to 18 weeks)
Beck Depression Inventory (BDI-II)
Time frame: Weekly (up to 18 weeks)
Deficits in Emotion Regulation Scale (DERS): Emotion Awareness and Nonacceptance of Negative Emotional Responses subscales
Time frame: Weekly (up to 18 weeks)
Southampton Mindfulness Questionnaire (SMQ)
Time frame: Weekly (up to 18 weeks)
Multi-dimensional Experiential Avoidance Questionnaire (MEAQ): Distraction/Suppression subscale
Time frame: Weekly (up to 18 weeks)
Emotion Regulation Questionnaire (ERQ)
Time frame: Weekly (up to 18 weeks)
Insomnia Severity Index (ISI)
Time frame: Weekly (up to 18 weeks)
Subjective Symptoms Scale (SSS)
Time frame: Weekly (up to 18 weeks)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
Derived from this study: PubMed 33884617Witt 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kate H Bentley, M.A. principal investigator

Boston University

David H Barlow, Ph.D. principal investigator

Boston University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of non-suicidal self-injurious thoughts and behaviors (time frame: Daily (up to 126 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02060448, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2017; AzTrials last refreshed its copy on 31 Oct 2026.