Self-Injurious BehaviorNCT04244786
Treating Self Injurious Behavior: A Novel Brain Stimulation Approach
A study testing Transcranial direct current stimulation in people with Self-Injurious Behavior and Self Harm, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The purpose of this study is to explore the tolerability and effectiveness of transcranial direct current stimulation (tDCS) as a potential treatment for non-suicidal self-injury (NSSI). Individuals who engage in frequent NSSI will be randomized to 12 administrations of an active vs. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Self-Injurious Behavior, Self Harm, Self-injury
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 29 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60
- Frequent current NSSI (including cutting in which the skin is broken; self-hitting in which there is bruising; or burning in which there is evidence of a burn. Will not enroll if skin-picking or scratching is the only form of self-injury): has engaged in ≥2 episodes of NSSI in the two months prior to enrollment
- Capacity to provide informed consent
- If carries a diagnosis of bipolar I or II disorder, taking or willing to begin a therapeutic dose of a mood stabilizer.
- Normal hearing.
- Physical capacity (e.g., manual dexterity) to set-up and self-administer tDCS. -
Who cannot join
- Unstable medical conditions based on medical history or physical examination
- Current psychotic disorder, mania, hypomania, intellectual disability
- Dermatologic condition resulting in non-intact skin on the scalp
- Significant suicidal ideation with a plan and intent that cannot be managed safely as an outpatient
- Pregnancy, currently lactating, or planning to conceive during the course of study participation.
- A neurological disease or prior head trauma with evidence of cognitive impairment. Subjects who endorse a history of prior head trauma and score ≥ 1.5 standard deviations below the mean on the Trailmaking A\&B will be excluded from study participation.
Show all 18Show fewer
- Current alcohol or substance use disorder that is severe according to DSM-V criteria
- Individuals who initiated or increased the dose of concurrent psychiatric medications (including antidepressants, anxiolytics, antipsychotic medications, mood stabilizers, and benzodiazepines) within two weeks prior to enrollment
- Individuals who initiated psychotherapy within two weeks prior to enrollment
- Current seizure disorder.
- Use of anticonvulsant medications that target the GABA system (e.g., gabapentin).
- Individuals currently using benzodiazepines who are unwilling or unable to refrain from the use of benzodiazepine medications for at least 72 hours before the first tDCS session and throughout the duration of the 2-week tDCS intervention.
- Metal implants or paramagnetic objects contained within the body (including heart pacemaker, shrapnel, or surgical prostheses) which may present a risk to the subject or interfere with the MRI scan, according to the guidelines set forth in the following reference book commonly used by neuroradiologists: "Guide to MR procedures and metallic objects," F.G. Shellock, Lippincott Williams and Wilkins NY 2001. Additionally transdermal patches will be removed during the MR study at the discretion of the investigator.
- Claustrophobia significant enough to interfere with MRI scanning
- Weight that exceeds 325 lbs or inability to fit into MRI scanner
- Suicide attempt within the past 3 months
- Serious self-harm resulting in hospitalization within the past 3 months.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute/Columbia University
New York, New York, 10032
About this study
The purpose of this study is to explore the tolerability and effectiveness of transcranial direct current stimulation (tDCS) as a potential treatment for non-suicidal self-injury (NSSI). Individuals who engage in frequent NSSI will be randomized to 12 administrations of an active vs. inactive form of tDCS, paired with an Attention Training Technique task, over a two-week period. Functional MRI may be performed before and after this two week period. NSSI urges and behaviors will be monitored before, during, and after the period of tDCS administrations.
Read the detailed description
The purpose of this study is to explore the tolerability and effectiveness of transcranial direct current stimulation (tDCS) as a potential treatment for non-suicidal self-injury (NSSI). NSSI is the deliberate attempt to harm oneself, most often through cutting or burning, without suicidal intent. NSSI is a maladaptive emotion-regulation strategy often triggered by negative emotions, especially those involving feelings of rejection. tDCS is a low-cost, portable, well-tolerated, non-invasive form of brain stimulation that delivers a low current to a specific area of the brain via electrodes. Several studies have demonstrated its effectiveness in treating an array of conditions, depending on electrode placement, including depression and chronic pain. tDCS may also facilitate adaptive emotion regulation; researchers have also successfully used tDCS to reduce negative emotions and aggressive responses to social rejection. The investigators therefore seek to explore tDCS as a potential treatment for NSSI. This pilot feasibility study seeks 1) to examine how tDCS is tolerated in a sample of individuals who engage in frequent NSSI; 2) to gather pilot data regarding changes in emotional and neural responses during a social task after a series of tDCS sessions in this clinical population of individuals who engage in NSSI; 3) to gather pilot data on the effects of tDCS on NSSI behaviors and urges. The investigators seek to recruit a sample of 22 individuals who engage in frequent NSSI to complete all study procedures. Individuals will be randomized to receive active- or sham-tDCS for two twenty-minute applications on each of six alternating sessions over approximately two weeks for a total of 12 tDCS administrations, each paired with an Attention Training Task. Functional MRI (fMRI) may be performed at baseline and again after the completion of 12 applications of tDCS. Subjects' NSSI and urges to engage in NSSI will be recorded for four weeks in real-time, using an iPod- based system that reminds subjects to stop at certain times during the day to record their thoughts, feelings, and behaviors. This will allow measurement of NSSI urges and behaviors for one week before, two weeks during, and one week after the tDCS intervention. The long-term goal of this study is to identify a novel form of treatment for NSSI and to better understand NSSI pathophysiology.
- Conditions
- Self-Injurious Behavior, Self Harm, Self-injury, Self-inflicted Injury, Self Injurious Behavior Without Suicidal Intent, Non-Suicidal Self Injury
- Being tested
- Transcranial direct current stimulation, No intervention
- Keywords
- Transcranial direct current stimulation, Transcranial electric stimulation, non-invasive brain stimulation, tDCS
- Medical subject headings
- Self-Injurious Behavior, Depression, Bipolar Disorder, Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
tDCS is a low-cost, portable, well-tolerated, non-invasive form of brain stimulation that delivers a low current to a specific area of the brain via electrodes.
No interventionOther
No intervention for participants who discontinued prior to randomization
| Study group | Role | What they receive |
|---|---|---|
| active anodal tDCS to ventrolateral prefrontal cortex (VLPFC) | Active comparator | active anodal tDCS to ventrolateral prefrontal cortex (VLPFC).
1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6-sessions Receives: Device: Transcranial direct current stimulation |
| sham anodal tDCS to VLPFC | Sham comparator | sham anodal tDCS to VLPFC
Identical electrode montage, 12 administrations of sham tDCS over 6 sessions. Receives: Device: Transcranial direct current stimulation |
| Discontinued prior to randomization | Other | Participants who enrolled in the study but discontinued before being randomized to either active or sham arms of the study Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Processing (Cyberball) fMRI Task: fMRI Responses
The Cyberball task is a task used during functional MRI scanning. During the task, individuals play a virtual ball-tossing game, playing catch with two computer avatars, and have a social exclusion experience when the avatars stop tossing the ball to them. The outcome measure is a subtraction of a measure of brain activity (fMRI BOLD signal) during portions of the task when the individual is included in the virtual ball-tossing game as compared to periods when the individual is excluded (i.e. fMRI BOLD signal inclusion periods - fMRI BOLD signal exclusion periods). This is quantified in 7 specific brain regions specified in the table below. dACC = dorsal anterior cingulate. vlPFC = ventrolateral prefrontal cortex. AI = anterior insula. The unit of measurement is a beta-weight from a general linear model (a statistical model) and a higher value reflects greater activity in a given brain region during experiences of social exclusion as compared to social inclusion.
Measured: Pre-treatment (baseline) and post-treatment (up to 2 weeks)
Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior
EMA assessment of NSSI urges and behavior before, during, and after tDCS intervention. EMA is a tool through which participants can respond to a brief questionnaire on a smartphone device while going about their daily lives. Participants were prompted to complete a brief questionnaire 6 times per day over a 4 week period (one week before tDCS (baseline), 2 weeks during tDCS (during tDCS), and one week after the final tDCS administration (post-tDCS)), which asks questions about urges to engage in NSSI and in actual NSSI behavior. Scores, coded on a scale from 1-5, are averaged across all prompts during the time period (baseline, during tDCS, post-tDCS). A higher score indicates more severe symptoms except for "success at resisting thoughts", which is reverse-coded.
Measured: One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS)
Self Injurious Thoughts and Behaviors Inventory Part 1
Selected items from the Self-Injurious Thoughts and Behaviors Interview (SITBI) were used at baseline and after the tDCS or sham intervention as outcome measures in this study. These items ask participants to report on their NSSI thoughts and behaviors over the past week. The following items are reported in this table:
Sitbi 58: At their worst, how intense were your thoughts about engaging in NSSI? (0: very mild to 4: very severe) sitbi 59: On average, how intense were your thoughts about engaging in NSSI? (0: very mild to 4: very severe)
Measured: Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)
Ecological Momentary Assessment (EMA): NSSI Urges and Behavior
EMA assessment of NSSI urges and behavior before, during, and after tDCS intervention. EMA is a tool through which participants can respond to a brief questionnaire on a smartphone device while going about their daily lives. Participants were prompted to complete a brief questionnaire 6 times per day over a 4 week period (one week before tDCS (baseline), 2 weeks during tDCS (during tDCS), and one week after the final tDCS administration (post-tDCS)), which asks questions about urges to engage in NSSI and in actual NSSI behavior. Items refer to the proportion of survey responses in which an individual endorsed the given thought or behavior or attempted to resist NSSI thoughts since the previous response (0 to 1), with "yes" scored as 1 and "no" scored as a zero.
Measured: One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS)
Self Injurious Thoughts and Behaviors Inventory Part 2
Selected items from the Self-Injurious Thoughts and Behaviors Interview (SITBI) were used at baseline and after the tDCS or sham intervention as outcome measures in this study. These items ask participants to report on their NSSI thoughts and behaviors over the past week. The following item is reported in this table:
sitbi 68: How many times [did you self-injure] in the past week? (number entered, minimum = 0, maximum = no limit)
Measured: pre-treatment (baseline) and post-treatment (up to 2 weeks)
Self Injurious Thoughts and Behaviors Inventory Part 3
Selected items from the Self-Injurious Thoughts and Behaviors Interview (SITBI) were used at baseline and after the tDCS or sham intervention as outcome measures in this study. These items ask participants to report on their NSSI thoughts and behaviors over the past week. The following item is reported in this table:
sitbi 60: When you have had these thoughts: how long have they usually lasted? (0: 0 seconds to 6: more than 2 days)
Measured: Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)
Self Injurious Thoughts and Behaviors Inventory Part 4
Selected items from the Self-Injurious Thoughts and Behaviors Interview (SITBI) were used at baseline and after the tDCS or sham intervention as outcome measures in this study. These items ask participants to report on their NSSI thoughts and behaviors over the past week. The following items are reported here:
sitbi 61: What is the likelihood you will have thoughts about engaging in NSSI in the future? (0: very unlikely to 4: very likely) sitbi 72: What do you think is the likelihood you will engage in NSSI in the future? (0: very unlikely to 4: very likely)
Measured: Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 Oct 2019
- Primary completion29 Jul 2022
- Study completion29 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Self-Injurious BehaviorStudies 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
- Model description
- Double-blind, randomized, sham-controlled trial. 2 arms of clinical trial. Listing 3 arms to include an arm for individuals who signed consent but discontinued prior to randomization and clinical intervention, to describe available data and adverse events in this group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Miller, New York State Psychiatric Institute
- Investigators
- Jeffrey M Miller, MD, Principal investigator, NYSPI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244786
- Sponsor's protocol ID
- #7170
- Status last verified
- Jun 2024
- First submitted
- 23 Oct 2019
- Last updated
- 3 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Scan results, questionnaire answers, and data collected during the task may be used in future studies, and if shared with other investigators, information that identifies the scan, questionnaire responses, or task data with you will be removed before hand.
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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Self Injurious Behavior: A Novel Brain Stimulation Approach
- ClinicalTrials.gov ID
- NCT04244786
- Acronym / sponsor ID
- #7170
- Conditions
- Self-Injurious Behavior, Self Harm, Self-injury, Self-inflicted Injury, Self Injurious Behavior Without Suicidal Intent, Non-Suicidal Self Injury
- Keywords
- Transcranial direct current stimulation, Transcranial electric stimulation, non-invasive brain stimulation, tDCS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 28 Jan 2020 (actual)
- Results
- Posted 3 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore the tolerability and effectiveness of transcranial direct current stimulation (tDCS) as a potential treatment for non-suicidal self-injury (NSSI). Individuals who engage in frequent NSSI will be randomized to 12 administrations of an active vs. inactive form of tDCS, paired with an Attention Training Technique task, over a two-week period. Functional MRI may be performed before and after this two week period. NSSI urges and behaviors will be monitored before, during, and after the period of tDCS administrations.
Detailed description
The purpose of this study is to explore the tolerability and effectiveness of transcranial direct current stimulation (tDCS) as a potential treatment for non-suicidal self-injury (NSSI). NSSI is the deliberate attempt to harm oneself, most often through cutting or burning, without suicidal intent. NSSI is a maladaptive emotion-regulation strategy often triggered by negative emotions, especially those involving feelings of rejection. tDCS is a low-cost, portable, well-tolerated, non-invasive form of brain stimulation that delivers a low current to a specific area of the brain via electrodes. Several studies have demonstrated its effectiveness in treating an array of conditions, depending on electrode placement, including depression and chronic pain. tDCS may also facilitate adaptive emotion regulation; researchers have also successfully used tDCS to reduce negative emotions and aggressive responses to social rejection. The investigators therefore seek to explore tDCS as a potential treatment for NSSI. This pilot feasibility study seeks 1) to examine how tDCS is tolerated in a sample of individuals who engage in frequent NSSI; 2) to gather pilot data regarding changes in emotional and neural responses during a social task after a series of tDCS sessions in this clinical population of individuals who engage in NSSI; 3) to gather pilot data on the effects of tDCS on NSSI behaviors and urges. The investigators seek to recruit a sample of 22 individuals who engage in frequent NSSI to complete all study procedures. Individuals will be randomized to receive active- or sham-tDCS for two twenty-minute applications on each of six alternating sessions over approximately two weeks for a total of 12 tDCS administrations, each paired with an Attention Training Task. Functional MRI (fMRI) may be performed at baseline and again after the completion of 12 applications of tDCS. Subjects' NSSI and urges to engage in NSSI will be recorded for four weeks in real-time, using an iPod- based system that reminds subjects to stop at certain times during the day to record their thoughts, feelings, and behaviors. This will allow measurement of NSSI urges and behaviors for one week before, two weeks during, and one week after the tDCS intervention. The long-term goal of this study is to identify a novel form of treatment for NSSI and to better understand NSSI pathophysiology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blind, randomized, sham-controlled trial. 2 arms of clinical trial. Listing 3 arms to include an arm for individuals who signed consent but discontinued prior to randomization and clinical intervention, to describe available data and adverse events in this group.
| Arm | Type | Receives |
|---|---|---|
| active anodal tDCS to ventrolateral prefrontal cortex (VLPFC) | Active comparator | Device: Transcranial direct current stimulationactive anodal tDCS to ventrolateral prefrontal cortex (VLPFC). 1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6-sessions |
| sham anodal tDCS to VLPFC | Sham comparator | Device: Transcranial direct current stimulationsham anodal tDCS to VLPFC Identical electrode montage, 12 administrations of sham tDCS over 6 sessions. |
| Discontinued prior to randomization | Other | Other: No interventionParticipants who enrolled in the study but discontinued before being randomized to either active or sham arms of the study |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-60
- Frequent current NSSI (including cutting in which the skin is broken; self-hitting in which there is bruising; or burning in which there is evidence of a burn. Will not enroll if skin-picking or scratching is the only form of self-injury): has engaged in ≥2 episodes of NSSI in the two months prior to enrollment
- Capacity to provide informed consent
- If carries a diagnosis of bipolar I or II disorder, taking or willing to begin a therapeutic dose of a mood stabilizer.
- Normal hearing.
Key exclusion criteria (18 listed)
- Unstable medical conditions based on medical history or physical examination
- Current psychotic disorder, mania, hypomania, intellectual disability
- Dermatologic condition resulting in non-intact skin on the scalp
- Significant suicidal ideation with a plan and intent that cannot be managed safely as an outpatient
- Pregnancy, currently lactating, or planning to conceive during the course of study participation.
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 |
|---|---|---|
| Transcranial direct current stimulationtDCS is a low-cost, portable, well-tolerated, non-invasive form of brain stimulation that delivers a low current to a specific area of the brain via electrodes. | Device | active anodal tDCS to ventrolateral prefrontal cortex (VLPFC), sham anodal tDCS to VLPFC |
| No interventionNo intervention for participants who discontinued prior to randomization | Other | Discontinued prior to randomization |
Primary outcome
Social Processing (Cyberball) fMRI Task: fMRI Responses
Time frame: Pre-treatment (baseline) and post-treatment (up to 2 weeks)
The Cyberball task is a task used during functional MRI scanning. During the task, individuals play a virtual ball-tossing game, playing catch with two computer avatars, and have a social exclusion experience when the avatars stop tossing the ball to them. The outcome measure is a subtraction of a measure of brain activity (fMRI BOLD signal) during portions of the task when the individual is included in the virtual ball-tossing game as compared to periods when the individual is excluded (i.e. fMRI BOLD signal inclusion periods - fMRI BOLD signal exclusion periods). This is quantified in 7 specific brain regions specified in the table below. dACC = dorsal anterior cingulate. vlPFC = ventrolateral prefrontal cortex. AI = anterior insula. The unit of measurement is a beta-weight from a general linear model (a statistical model) and a higher value reflects greater activity in a given brain region during experiences of social exclusion as compared to social inclusion.
Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior
Time frame: One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS)
EMA assessment of NSSI urges and behavior before, during, and after tDCS intervention. EMA is a tool through which participants can respond to a brief questionnaire on a smartphone device while going about their daily lives. Participants were prompted to complete a brief questionnaire 6 times per day over a 4 week period (one week before tDCS (baseline), 2 weeks during tDCS (during tDCS), and one week after the final tDCS administration (post-tDCS)), which asks questions about urges to engage in NSSI and in actual NSSI behavior. Scores, coded on a scale from 1-5, are averaged across all prompts during the time period (baseline, during tDCS, post-tDCS). A higher score indicates more severe symptoms except for "success at resisting thoughts", which is reverse-coded.
Self Injurious Thoughts and Behaviors Inventory Part 1
Time frame: Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)
Selected items from the Self-Injurious Thoughts and Behaviors Interview (SITBI) were used at baseline and after the tDCS or sham intervention as outcome measures in this study. These items ask participants to report on their NSSI thoughts and behaviors over the past week. The following items are reported in this table: Sitbi 58: At their worst, how intense were your thoughts about engaging in NSSI? (0: very mild to 4: very severe) sitbi 59: On average, how intense were your thoughts about engaging in NSSI? (0: very mild to 4: very severe)
Ecological Momentary Assessment (EMA): NSSI Urges and Behavior
Time frame: One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS)
EMA assessment of NSSI urges and behavior before, during, and after tDCS intervention. EMA is a tool through which participants can respond to a brief questionnaire on a smartphone device while going about their daily lives. Participants were prompted to complete a brief questionnaire 6 times per day over a 4 week period (one week before tDCS (baseline), 2 weeks during tDCS (during tDCS), and one week after the final tDCS administration (post-tDCS)), which asks questions about urges to engage in NSSI and in actual NSSI behavior. Items refer to the proportion of survey responses in which an individual endorsed the given thought or behavior or attempted to resist NSSI thoughts since the previous response (0 to 1), with "yes" scored as 1 and "no" scored as a zero.
Self Injurious Thoughts and Behaviors Inventory Part 2
Time frame: pre-treatment (baseline) and post-treatment (up to 2 weeks)
Selected items from the Self-Injurious Thoughts and Behaviors Interview (SITBI) were used at baseline and after the tDCS or sham intervention as outcome measures in this study. These items ask participants to report on their NSSI thoughts and behaviors over the past week. The following item is reported in this table: sitbi 68: How many times [did you self-injure] in the past week? (number entered, minimum = 0, maximum = no limit)
Self Injurious Thoughts and Behaviors Inventory Part 3
Time frame: Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)
Selected items from the Self-Injurious Thoughts and Behaviors Interview (SITBI) were used at baseline and after the tDCS or sham intervention as outcome measures in this study. These items ask participants to report on their NSSI thoughts and behaviors over the past week. The following item is reported in this table: sitbi 60: When you have had these thoughts: how long have they usually lasted? (0: 0 seconds to 6: more than 2 days)
Self Injurious Thoughts and Behaviors Inventory Part 4
Time frame: Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)
Selected items from the Self-Injurious Thoughts and Behaviors Interview (SITBI) were used at baseline and after the tDCS or sham intervention as outcome measures in this study. These items ask participants to report on their NSSI thoughts and behaviors over the past week. The following items are reported here: sitbi 61: What is the likelihood you will have thoughts about engaging in NSSI in the future? (0: very unlikely to 4: very likely) sitbi 72: What do you think is the likelihood you will engage in NSSI in the future? (0: very unlikely to 4: very likely)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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: Yes. Scan results, questionnaire answers, and data collected during the task may be used in future studies, and if shared with other investigators, information that identifies the scan, questionnaire responses, or task data with you will be removed before hand.
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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.
Jeffrey M Miller, MD principal investigator
NYSPI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation in people with Self-Injurious Behavior and Self Harm, run by New York State Psychiatric Institute at 1 site in United States.
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 6 inclusion and 18 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 3 Jul 2024. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 3 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Social Processing (Cyberball) fMRI Task: fMRI Responses (time frame: Pre-treatment (baseline) and post-treatment (up to 2 weeks)). The study lists 7 primary outcomes in all. 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 NCT04244786, 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 3 Jul 2024.