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Combined TMS and Brief Cognitive Behavioral Therapy to Reduce Suicide

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ClinicalTrials.gov Identifier: NCT03952468
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
High rates of Veteran suicide remain a tragedy. Rates of Veteran suicide have not decreased for 10 years, despite the best efforts of the field. Those interventions that do exist have only modest effects, which are simply insufficient for the magnitude of the problem. This proposal will combine two treatments - brief cognitive behavioral therapy (BCBT) and repetitive transcranial magnetic stimulation (TMS). Both of these interventions can reduce suicide and are available at Veterans Affairs Medical Centers across the country, yet to date no one has combined these therapies. This proposal will test the effect of this combination, and, if successful, will lead to a novel yet implementable new treatment to reduce Veteran suicide.

Condition or disease Intervention/treatment Phase
Suicide Device: Transcranial Magnetic Stimulation Other: Brief Cognitive Behavioral Therapy Phase 2 Phase 3

Detailed Description:

The goal of the proposed study is to test the effect of adding Transcranial Magnetic Stimulation (TMS) to Brief Cognitive Behavioral Therapy (BCBT) to reduce Veterans' rates of suicide ideation and related behaviors. Over 20 Veterans die each day of suicide and rates have not appreciably decreased in the last ten years.

BCBT is a well-established and efficacious treatment that is an extension of Cognitive Behavioral Therapy, a treatment that is widely implemented across VA health care systems. However, not all patients respond to BCBT. Thus finding ways to enhance treatment efficacy for reducing suicide is critical. Transcranial Magnetic Stimulation (TMS) may be an optimal treatment to use in conjunction with psychotherapy. TMS is a noninvasive technique that uses a pulsed magnetic field to induce neuronal depolarization in a targeted brain region, typically the left dorsolateral prefrontal cortex. TMS can reduce psychiatric symptoms associated with suicide risk in Veterans, including depression and PTSD. Furthermore, TMS is not associated with the systemic and costly side effects associated with medications used for these disorders (e.g., weight gain, diabetes, sexual side effects).

The primary objective of this study is to conduct a fully-powered randomized controlled trial evaluating the effect of adding a standard TMS course of treatment to BCBT to reduce suicide behaviors in a sample of Veterans hospitalized for suicide behavior. One hundred and thirty (130) Veterans admitted to the psychiatric unit for suicide ideation or attempts will be randomly assigned to either active TMS plus BCBT or to sham TMS plus BCBT. Participants will be assessed at baseline, post treatment, six, and 12 months post hospital discharge. Efficacy of the program will be determined by examining a primary suicide composite outcome and several secondary outcomes including suicide attempt, time to first attempt, number of re-hospitalizations and severity and severity of suicidal ideation. Secondary analyses will be conducted to help identify the types of patients who will receive the most benefit from the addition of TMS to BCBT Brief Cognitive Behavioral Therapy for suicide.

If successful, this study would result in a combined treatment to decrease suicide ideation and related behaviors. The proposal addresses HSRD post-deployment health priority, specifically suicide prevention and is innovative in that it will be the first study to examine efficacy of combined treatment specifically for suicide prevention.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 130 Veterans admitted to the Providence VAMC psychiatric inpatient unit due to suicide attempt or ideation with intent to make an attempt will be recruited and randomly assigned to receive: a) active TMS+BCBT or b) sham TMS+BCBT. Both interventions will begin within the week following hospital discharge, and Veterans will be followed for 12 months post-discharge.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Prior to each TMS session, un-blinded study staff will attach the appropriate (i.e., active or sham) coil according to the participants' randomization code (obtained from the urn randomization computer program). This will facilitate "triple blind" stimulation, where the participant, TMS provider, and outcome rater are blind to group assignation.
Primary Purpose: Treatment
Official Title: Combined Transcranial Magnetic Stimulation and Brief Cognitive Therapy to Reduce Suicide Behavior in High-Risk Veterans
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Active Comparator: TMS + Brief Cognitive Behavioral Therapy
Combined transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide
Device: Transcranial Magnetic Stimulation
Administration of rapidly fluctuating magnetic field, delivered over the dorsolateral prefrontal cortex.
Other Name: TMS

Other: Brief Cognitive Behavioral Therapy
BCBT is a well-established and efficacious treatment that is an extension of Cognitive Behavioral Therapy, a treatment that is widely implemented across VA health care systems.

Sham Comparator: Sham TMS + Brief cognitive behavioral therapy
Sham Transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide
Device: Transcranial Magnetic Stimulation
Administration of rapidly fluctuating magnetic field, delivered over the dorsolateral prefrontal cortex.
Other Name: TMS

Other: Brief Cognitive Behavioral Therapy
BCBT is a well-established and efficacious treatment that is an extension of Cognitive Behavioral Therapy, a treatment that is widely implemented across VA health care systems.




Primary Outcome Measures :
  1. Change in Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: 12 month follow up ]
    Interview administered assessment of suicide ideation and behavior. The interview consists of two subscales, an ideation and behavior subscale. The severity of ideation subscale is rated on a 5-point ordinal scale: 1 = wish to be dead, 2 = nonspecific active suicidal thoughts, 3 = suicidal thoughts with methods, 4 = suicidal intent, and 5 = suicidal intent with plan. The suicidal behavior subscale is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and nonsuicidal self-injurious behavior.


Secondary Outcome Measures :
  1. Change in Beck Scale for Suicide Ideation (SSI) [ Time Frame: 12 month follow up ]

    A 21-item interview administered measure. The first 5 items are screeners (wish to live, wish to die, and desire to attempt suicide), followed by 14 items to assess suicidal risk factors. The last 2 items capture previous suicide attempts.

    Each item is rated on a 3-point scale ranging from 0 to 2 according to suicidal intensity. The SSI is scored by adding up the ratings (0-2) from the first 19 items.


  2. Change in World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) [ Time Frame: 12 month follow up ]
    The WHODAS 2.0 is a 12-question, self-administered questionnaire and generic assessment instrument for health and disability that covers six domains: Cognition (items 3 and 6), Mobility (items 1 and 7), Self-care (items 8 and 9), Getting Along (items 10 and 11), Life Activities (items 2 and 12), and Participation (items 4 and 5). Items are rated from "None," "Mild," "Moderate," "Severe," to "Extreme or cannot do," indicating difficulty over the past month.

  3. Change in Treatment History Questionnaire [ Time Frame: 12 month follow up ]
    Interview based assessment of treatment use including hospitalizations, outpatient treatment, medication use, and emergency services. Participants report the number and type of outpatient, inpatient, residential, and emergency/crisis treatment received since last visit.



Information from the National Library of Medicine

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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:

-Suicide attempt or suicidal ideation with intent to make a suicide attempt within 48 hours of hospitalization as indicated on the hospital chart and confirmed by administration of the C-SSRS.

Exclusion Criteria:

  • Primary psychotic disorder
  • Bipolar disorder
  • Cognitive impairment which would interfere with adequate participation in the project (MMSE < 20).
  • For safety, participants must meet established screening criteria safety during MRI, which is implemented as a conservative measure given the application of TMS in this population, since MRI involves magnetic fields at similar intensity to those emitted from the stimulation coil. These measures require a patient not having the following (unless MRI-safe):

    • Cardiac pacemaker
    • Implanted device (deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord.
  • TMS-specific exclusions are:

    • pregnancy/lactation, or planning to become pregnant during the study
    • lifetime history of moderate or severe traumatic brain injury (TBI)
    • Current unstable medical conditions
    • Current (or past if appropriate) significant neurological disorder
    • Lifetime history seizure disorder
    • Primary or secondary CNS tumors
    • Stroke
    • Cerebral aneurysm.
    • Other exclusions are conditions that would like to be worsened by TMS, such as bipolar disorder
    • Place Veterans at greater risk of seizures from TMS, such as severe and uncontrolled substance use disorder
    • Inability to participate in CBT
    • Other conditions or circumstance that, in the opinion of the investigator team, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments

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): NCT03952468


Contacts
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Contact: Jennifer M Primack, PhD MA (857) 472-3044 Jennifer.Primack@va.gov
Contact: Noah S Philip, MD (401) 273-7100 ext 6200 noah.philip@va.gov

Locations
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United States, Rhode Island
Providence VA Medical Center, Providence, RI Not yet recruiting
Providence, Rhode Island, United States, 02908
Contact: Candace M Shuman    (401) 273-7100 ext 3872    Candace.Shuman@va.gov   
Contact: Debra D'Allesandro, BA    (401) 273-7100 ext 6238    Debra.D'Allesandro@va.gov   
Principal Investigator: Jennifer Marie Primack, PhD MA         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Jennifer Marie Primack, PhD MA Providence VA Medical Center, Providence, RI

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03952468     History of Changes
Other Study ID Numbers: IIR 17-201
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
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: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
suicide prevention
Veterans

Additional relevant MeSH terms:
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Suicide
Self-Injurious Behavior
Behavioral Symptoms